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- 2026-06-06 10:10:30
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- Curacle resumes licensing-out activities after 2 years
- by Cha, Ji-Hyun May 13, 2026 09:10am
- Curacle, a biotech company specializing in new drug development, has successfully licensed out a preclinical-stage bispecific antibody candidate in a deal valued at over KRW 1 trillion. This marks its first licensing-out achievement in 2 years, following a notice of rights termination regarding a retinal disease treatment from a French ophthalmology-focused pharmaceutical company.The deal is expected to significantly reduce Curacle’s risk of being designated as an administrative issue stock due to revenue requirements. However, concerns remain due to limited disclosure about the counterparty.MT-103 global deal worth KRW 1.5 trillion… Curacle’s share KRW 781.8 billionAccording to filings with the Financial Supervisory Service, Curacle recently signed a global licensing agreement with US-based Memento Medicines for the development and commercialization of its bispecific antibody candidate ‘MT-103.’ Under the agreement, Memento gains exclusive worldwide rights to develop, manufacture, and commercialize MT-103.The total deal value is USD 1.077 billion (KRW 1.56 trillion). Of this, the non-refundable upfront payment is USD 8 million (0.7%), with USD 82.25 million in development and approval milestones and up to USD 987.5 million in royalties upon commercialization.Curacle and MabTics will share revenues 50:50 under a joint R&D agreement. Reflecting this, Curacle’s share amounts to USD 538.875 million (KRW 781.8 billion). The company’s upfront payment share is USD 4 million.Overview of Curacle’s bispecific antibody candidate ‘MT-103’ for the treatment of retinal diseases (Source: Curacle)MT-103 is a bispecific antibody candidate for retinal diseases co-developed by Curacle and MabTics. Curacle secured the antibody pipeline through a partnership signed in June 2023 and then signed a joint R&D agreement in July of the following year. MT-103 is one of the key antibody pipeline assets secured through this process.MT-103 is a bispecific antibody that combines an antibody that inhibits vascular endothelial growth factor (VEGF), which induces angiogenesis, with an antibody that activates the Tie2 receptor, which stabilizes blood vessels. While the existing bispecific antibody therapy ‘Vabysmo’ indirectly induces Tie2 activation by inhibiting VEGF and angiopoietin-2 (Ang-2), MT-103 is designed to directly activate Tie2. The company explains that this is expected to deliver differentiated therapeutic effects in patient groups that do not respond sufficiently to existing anti-VEGF therapies or Vabysmo.Preclinical data presented at ARVO 2026 by Curacle and MabTics, MT-103 induced Tie2 receptor phosphorylation and inhibited VEGF-induced signaling in cell experiments. In endothelial cell-based vascular leakage assays, it also demonstrated an effect of reducing vascular permeability. In animal models, the drug was shown to reduce pathological neovascularization, inhibit vascular leakage, improve retinal vascular remodeling, and alleviate inflammatory responses.First deal since CU06 return… expected to ease revenue-related administrative issue riskThis deal marks Curacle’s first licensing success since its previous retinal therapy candidate CU06 was returned in 2024 by a French ophthalmology-focused pharmaceutical company. In May 2024, Curacle received a notice of termination of the technology export agreement and a return of rights regarding the candidate drug ‘CU06’ for the treatment of diabetic macular edema and wet age-related macular degeneration from Théa Open Innovation, a French ophthalmology-focused pharmaceutical company.The contract, signed in October 2021 for a total of USD 163.5 million, transferred the global development and commercialization rights for CU06-RE (excluding Asia) to Théa. Although this contract was effectively Curacle’s only technology export achievement, it became void following the return of rights. This MT-103 agreement is considered significant as it marks Curacle’s first technology export achievement since then.With this agreement, Curacle is expected to fill the revenue gap that had effectively been left open. Curacle’s revenue has plummeted over the past 3 years. The company’s revenue, which stood at KRW 10.3 billion in 2023, fell by 84.5% to KRW 1.6 billion in 2024. Last year, revenue amounted to just KRW 7.1 million as the recognition of subsequent revenue was halted due to the termination of the CU06 technology export agreement. In effect, this means there was no revenue generated from its core business of new drug development.Consequently, the risk of being designated as an administrative issue stock due to revenue requirements has been largely alleviated. The company, which went public in 2021, saw the grace period for the designation criteria, triggered by revenue falling below KRW 3 billion, expire last year. The company faced the possibility of being designated as an administrative issue stock if it failed to meet this year’s revenue requirements; however, if the KRW 5.8 billion upfront payment from this contract is received as planned, that burden is expected to be significantly reduced.The company has also moved to secure a separate revenue base. Following the establishment of an API business division last year, the company completed a merger-by-absorption with the API firm Daesung Pharmtech in January of this year. A Curacle official stated, “We expect to receive the upfront payment for this contract at a time similar to that of a typical technology export contract. We will be able to meet the revenue requirements without issue through the absorption merger of the API that the company completed earlier this year.”Information on the contracting party is overly limited… in stark contrast with the D&D Pharmatech-Metsera caseHowever, some market observers have expressed skepticism regarding the substance of this agreement due to the limited information available about the counterparty. In its public disclosure, the company only stated that the counterparty is a US-based firm named Memento, without providing any further details. Basic information about Memento, such as its date of establishment, location, representative, and investors, cannot be verified, and the company does not even have a separate website.The company maintains that Memento is a NewCo-type entity established for the development of a specific pipeline and that it cannot disclose information on investors or management due to confidentiality clauses in the contract. The NewCo model involves establishing a separate new corporation for the purpose of developing a specific new drug candidate, attracting external investment, and pursuing clinical development and commercialization. Typically, such entities operate in “stealth mode” in the early stages, with confidentiality clauses preventing disclosure.A Curacle official stated, “The company cannot arbitrarily disclose information designated as confidential in the contract. It is a fact that the counterparty is a newly established entity in which a top-tier global venture capital (VC) firm has participated. We will be able to provide additional information once Memento begins its official promotional activities.”Industry observers point out that Curacle’s refusal to disclose information is excessively secretive, even considering the nature of the NewCo model. Even under the NCO model, the contract’s validity can only be recognized if it is backed by credible human and material resources. In particular, they argue that since major technology export contracts by listed companies directly impact stock prices and investment decisions, a minimum level of information disclosure is necessary to verify the identity of the contracting party.In the case of the contract between D&D Pharmatech and Metsera, cited as a successful example of a “Newco-style” technology export in the biotech industry, details such as the company’s purpose, headquarters location, major investors, founding entities, management team, and funding details were disclosed relatively specifically, even though the counterparty was a newly established entity.Metsera is a biotech startup established in New York, USA, in 2022 with the goal of developing an obesity treatment. Major U.S. biotech-focused venture capital firms ARCH Venture Partners and Population Health Partners (PHP) participated in its founding. PHP is an investment firm established by Ian C. Read, former chairman and CEO of Pfizer, and Clive Meanwell, founder of the Medicines Company. Meanwell is known for growing the Medicines Company and selling it to Novartis. These key figures are also positioned on Metsera’s board of directors and executive team. Clive Meanwell serves as Chairman, while Whit Bernard, formerly of PHP, serves as CEO, and co-founder J. Visioli serves as CFO and CBO.Metsera was acquired by the US big pharma company Pfizer last November, joining the ranks of global pharmaceutical firms just 3 years after its founding. Pfizer agreed to pay Metsera shareholders USD 65.60 per share in cash and an additional USD 20.70 in contingent value rights (CVR) based on clinical and regulatory milestones. The base enterprise value is USD 7 billion, and including the contingent payments, the total transaction value amounts to up to USD 86.3 per share.
- Company
- Intuitive Surgical doubles its growth in 5 years
- by Hwang, byoung woo May 13, 2026 09:10am
- Intuitive Surgical Korea, a leader in robotic surgery, continues to show strong growth.Since introducing the da Vinci surgical system in Korea in 2005, the company has achieved steady revenue growth, doubling its business over the past five years.Last year marked its 20th anniversary in Korea, surpassing 370,000 cumulative procedures and ushering in an era of “mainstream adoption of robotic surgery.”Doubles growth over 5 years… accelerating expansionThe revenue trend of Intuitive Surgical Korea (hereinafter Intuitive Korea) over the past five years can be summarized as a ‘high-growth trajectory.’Revenue grew from KRW 159.7 billion in 2021 to KRW 167.4 billion in 2022, then to KRW 212.9 billion in 2023, marking the first time the company surpassed KRW 200 billion in revenue.Since then, the company posted KRW 252.9 billion in revenue in 2024 and set a new record with KRW 342.4 billion in 2025.According to Intuitive, cumulative robotic surgeries in Korea surpassed 370,000 over the past 20 years through 2025, with procedures now performed at a rate of roughly “one every eight minutes” in Korea.In particular, the rapid increase in both clinical adoption and demand for equipment, to the extent that the number of single-port robotic surgeries ranks first in the world, served as the core foundation for this growth in performance.A detailed breakdown of revenue reveals a virtuous cycle between products and services.As of 2025, product sales, including da Vinci systems and surgical instruments, reached KRW 280.9 billion, accounting for 82% of total revenue. Service revenue, including system maintenance, totaled KRW 43.2 billion, while other revenue came in at KRW 18.2 billion.Compared to 2021, product sales more than doubled from KRW 130 billion, and service revenue also expanded by nearly KRW 20 billion from KRW 23.3 billion.In other words, as more robotic surgical systems are newly installed in hospitals (product revenue), the associated maintenance contracts (service revenue) accumulate, forming a stable structure that serves as a stable cash cow.Profitability also strengthens… operating profit surpasses KRW 10 billionProfitability indicators, including operating profit and net income, have also shown a positive trajectory.According to audit reports, operating profit grew steadily from KRW 4.7 billion in 2021 to ▲KRW 5.0 billion in 2022, ▲KRW 6.4 billion in 2023, and ▲KRW 7.6 billion in 2024. In 2025, it reached KRW 10.3 billion, surpassing the KRW 10 billion mark.Net income followed a similar upward trend.In 2021, the company recorded a net loss of KRW 63 million due to non-operating expenses and taxes, but rebounded to a net profit of KRW 3.4 billion in 2022.This was followed by net profits of ▲KRW 4.7 billion in 2023 and ▲KRW 5.3 billion in 2024, rising further to KRW 7.2 billion in 2025 alongside significant top-line expansion.However, as revenue surged, selling, general, and administrative (SG&A) expenses also increased substantially. SG&A rose from KRW 18 billion in 2021 to KRW 37.1 billion in 2025, more than doubling.That said, considering that the company’s workforce expanded from 139 employees as of March 2024 to around 200 by March 2026, the increase is more likely attributable to investment expansion rather than inefficiency.Expansion of da Vinci 5 and Ion… platform expansionThis growth coincides with the rollout of the company’s next-generation systems. The launch of da Vinci 5 in Korea in October 2024, making it the second country globally after the US, has been cited as a key growth driver.In addition, the company expanded into thoracic surgery and pulmonology diagnostics with the domestic launch of the robotic-assisted bronchoscopy system ‘Ion’ in August 2025.Product photo of the image-guided robot-assisted bronchoscopy system, IonIon uses a 3.5 mm ultra-thin robotic catheter to precisely access and diagnose lesions in peripheral lung regions that are otherwise difficult to reach. It is considered a potential game-changer in lung cancer diagnosis and treatment.In particular, the fact that Intuitive has designated Korea as a key starting point is another factor fueling expectations for continued sales growth.The company is currently establishing direct ties with the domestic robotic surgery research ecosystem, including donating the robotic surgery research platform ‘dVRK’ to the Daegu Gyeongbuk Institute of Science and Technology (DGIST) through the Intuitive Foundation (third such donation following Seoul National University and Yonsei University).Catherine Mohr, President of the Intuitive Foundation, who recently visited Korea, stated, “Korea contributes to the advancement of global surgical technology through its solid clinical foundation and active research in robotic-assisted surgery. During this visit, I confirmed the future potential of Korean healthcare.”Yong-bum Choi, CEO of Intuitive Surgical Korea, added, “This visit highlights Korea’s global standing in AI and robotic healthcare. We will strive to build an environment where more patients can benefit from treatment through ongoing education and collaboration.”
- Company
- 'Vadanem' prescription strategies specified
- by Son, Hyung Min May 12, 2026 11:30am
- The scope of Vadanem (vadadustat), a treatment for renal anemia, is expanding in clinical practice beyond being a simple alternative to Erythropoiesis-Stimulating Agents (ESAs). This follows the growing need for a patient-centered approach that considers application criteria based on dialysis status, the timing of treatment switching, and the specific characteristics of iron metabolism and the hemoglobin (Hb) response.Tanabe Pharma Korea and HK inno.N recently held the ‘New Paradigm VADANEM Symposium’ in Seoul to share clinical application strategies, focusing on application criteria by dialysis status, treatment switching timing, and the characteristics of iron metabolism and Hb response.On the first day, chaired by Professor Bum Soon Choi (Catholic Univ. College of Medicine), presentations were given by Professor Dong Ki Kim (Seoul National Univ. College of Medicine) and Professor Sungjin Jung (Catholic Univ. College of Medicine). On the second day, chaired by Professor Kwon-Wook Ju (Seoul National Univ. College of Medicine), the session featured presentations by Professor Gang Jee Ko (Korea Univ. College of Medicine) and Professor Eun Sil Koh (Catholic Univ. College of Medicine).Symposium commemorating the launch of Vadanem.Application strategies vary by dialysis status and ESA responseVadanem is an oral Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitor (HIF-PHI) that signals a shift away from the existing injection-centered treatment structure, dominated by ESAs. It has recently improved patient access following its inclusion in the domestic health insurance reimbursement list.However, experts reached consensus that a granular application strategy based on patient status is required in clinical practice, rather than solely on the convenience of an oral medication.Renal anemia is characterized by decreased erythropoietin (EPO) production as Chronic Kidney Disease (CKD) progresses, often accompanied by 'functional iron deficiency.' As hepcidin increases due to inflammation, a state arises in which iron cannot be utilized even when there is sufficient iron in the body.Given such an environment, 'ESA hyporesponsiveness,' where response to ESA treatment is poor, becomes an issue. Experts explained that for many patients, maintaining Hb levels is difficult despite high doses of ESA.Professor Dong Ki Kim said, "Since sufficient clinical experience with ESA treatment has been accumulated for dialysis patients, we should consider Hb variability and stability rather than simply switching drugs. New options can be reviewed for patients who have difficulty maintaining target Hb or experience high variability in existing treatments."He added, "For non-dialysis patients, the fact that it is an oral medication can serve as a significant variable in treatment selection. An approach that considers oral options from the initial treatment stage is entirely feasible."Additionally, it was noted that Vadanem could be considered an alternative for patient groups in whom Hb response is insufficient or variability is high despite ESA treatment. It was emphasized that the stability of Hb maintenance and treatment sustainability should be evaluated alongside simple numerical improvements.Experts suggested the following as potential patients for Vadanem ▲Patients with ESA hyporesponsiveness ▲Patients with concurrent inflammation ▲Non-dialysis patients with a high burden of injection therapy. A key point mentioned was that improvements in iron utilization efficiency can be expected in patients with functional iron deficiency.Another characteristic of Vadanem is its mechanistic differentiation regarding iron metabolism regulation. As it increases the efficiency of iron utilization in the body through the HIF pathway, analysis suggests that its coordination with iron supplementation strategies may differ from that of existing ESAs.Vadanem does not simply supplement EPO.It possesses a mechanism that induces "complete erythropoiesis" by simultaneously regulating iron absorption, transport, and utilization.Professor Sungjin Jung said, "HIF-PHI class treatments have the characteristic of regulating Hb more physiologically through mechanisms linked to iron metabolism. The fact that Hb increase patterns may appear differently compared to ESAs must be considered clinically."He emphasized, "Since treatment response can vary depending on iron status, an approach that evaluates iron metabolism indicators along with Hb levels is necessary."Symposium commemorating the launch of Vadanem.Hb response and iron metabolism variables…"Patient-specific approaches needed"Presenters explained that setting treatment goals based on patient characteristics is important, especially since the focus can be on maintaining Hb stably within a more physiological range rather than a rapid surge.For prescriptions, a strategy was suggested to start with 300 mg of Vadanem once daily, maintain it for a period, and then increase the dose based on response. It was emphasized that closely monitoring the rate of Hb increase in the early stages is crucial, and that dose adjustments are necessary if Hb rises too sharply.Furthermore, discussions on the timing of treatment switching continued. Switching to Vadanem can be a strategy for patient groups with declining response or side effect concerns during ESA treatment, and the possibility of considering oral agents from the initial treatment stage is expected to expand.Professor Gang Jee Ko said, "For patients whose ESA doses must be continuously raised or who have difficulty maintaining target Hb, treatment strategies need to be reviewed. For these patient groups, switching to Vadanem can be a realistic option."She added, "If a burden or compliance issue regarding injections arises during long-term treatment, switching to an oral agent is meaningful for patient management."Professor Koh Eun-sil also emphasized, "In the future, a trend may emerge where oral agents are considered as initial treatment options rather than just alternatives after ESA. It is important to flexibly design treatment strategies considering patient characteristics."Additionally, Professor Ko mentioned the need for managing drug interactions due to the nature of oral medications.Professor Ko concluded by explaining that "When co-administered with iron supplements or phosphate binders, drug absorption may decrease, so it is recommended to stagger administration times. Dose adjustments may also be necessary when co-administered with certain other drugs."
- Company
- Stricter regulations set to effectively block late generic entry
- by Chon, Seung-Hyun May 12, 2026 11:30am
- “85% of the lower value between the previous lowest price and the price reflecting failure to meet the 2 eligibility criteria.”The government plans to introduce a powerful price reduction mechanism for generics subject to the stepwise pricing system. Under the proposal, prices will be reduced by 15% based not only on the lowest listed price but also on prices reflecting unmet eligibility criteria. With the lower maximum generic price and stepwise reductions applied earlier, the price of the 14th generic entrant is expected to fall to less than half of the current level. The pharmaceutical industry is strongly opposing the move, arguing that reductions should be based solely on the lowest listed price.According to industry sources on the 11th, the Ministry of Health and Welfare presented a proposal in a working-level consultative body to strengthen the stepwise pricing threshold from the current 21st identical formulation to the 14th.The stepwise pricing system is structured so that the price ceiling decreases on a monthly basis, the later a generic drug enters the market. Under the current system, if there are more than 20 pre-listed identical products, the price of a generic drug entering the market as a latecomer is reduced by 15% each time.The government intends to incorporate not only the lowest price but also prices reflecting unmet eligibility criteria into the calculation.The government plans to maintain the approach implemented when the tiered pricing system was introduced in 2020, which assigns 85% of the lower of either the “immediately preceding lowest price” or the “price when two standard requirements are not met.”If drug prices that fail to meet standard requirements are factored into the stewpise pricing system, generic drug prices will drop exponentially.Under the eligibility criteria introduced in July 2020, generics must meet both requirements—conducting their own bioequivalence studies and using registered APIs—to receive the highest price. Failure to meet each criterion results in a 15% price reduction. From the current maximum of 53.55%, prices fall to 45.52% if one criterion is unmet, and 38.69% if both are unmet.AI-generated imageFor example, if all existing generics are priced at KRW 53.55, applying the lowest-price rule would result in a 15% reduction to KRW 45.52. However, applying the unmet-criteria rate of 38.69% leads to a further reduction to KRW 32.89, which is 38.6% lower than the lowest price.With upcoming reforms further lowering the maximum ceiling price for generics and increasing penalties for unmet criteria, the stepwise pricing system will become an even stronger price suppression mechanism.The Ministry of Health and Welfare’s revised drug pricing system, discussed at the Health Insurance Policy Deliberation Committee on March 26, includes a plan to lower the price calculation rate for generics and off-patent drugs from the current 53.55% to 45%.Under the current drug pricing system, which has been in effect since 2012, generics are granted a price premium of up to 59.5% of the original drug’s price prior to patent expiration upon initial listing, and the price cap is lowered to 53.55% 1 year later. New drugs whose patents have expired are also reduced to 53.55% of the pre-patent expiration price, similar to generics.Under the new system, both generics and off-patent drugs will be priced at 45% rather than 53.55%, and the uniform 59.5% premium for first generics will be abolished, replaced by differentiated incentives based on R&D investment. As a result, the long-standing ‘53.55%’ pricing benchmark introduced in 2012 will disappear after 14 years.The penalty for failing to meet maximum price criteria will also increase from 15% to 20%. If the base rate is set at 45%, generics failing one criterion will be priced at 36%, and those failing both at 28.8%.As a result, the 14th generic drug, to which the stepwise pricing applies, cannot exceed 24.48%—a 15% reduction from the 28.80% rate applied to generics failing to meet 2 maximum price criteria. Comparing the same 14th generic drug, if its price under the current system is KRW 53.55, whereas under the revised system, it drops to less than half that amount. The 15th and 16th generic drugs fall 38.6% from the lowest price, dropping 14.98% and 9.20%, respectively.Under the revised drug pricing system, the earlier application of the stepwise pricing system, a 15% stepwise price reduction, and a 20% price reduction for drugs that do not meet the highest-price requirement, creates a structure that effectively prevents late-entrant generics from entering the market.The pharmaceutical industry is strongly opposing the increasingly complex and aggressive pricing mechanism of the stepwise pricing system.The stepwise drug pricing system was previously abolished but has since been reintroduced. The Ministry of Health and Welfare abolished the tiered system as part of a 2012 reform of the drug pricing system. This allowed pharmaceutical companies to actively launch generics even in markets where patents had expired long ago, as they could still command high prices even with late market entry. However, as the problem of excessive generic proliferation became entrenched, the stepwise drug pricing system was revived after 8 years.Before 2012, generics could receive 54.4–68% of the original drug price, with stepwise reductions applied monthly based on the lowest existing price. While the maximum price for generics was set at 68% of the original drug’s pre-patent-expiry price, if 13 or more ‘first-to-market’ generics were listed simultaneously, the maximum price for generics was set at 54.4%. Subsequently, the maximum price for generics was reduced by 10% each time a new product was listed on a monthly basis. At that time, the price under the stepwise system was 10% lower than the lowest price of a pre-listed product.However, since 2020, the inclusion of unmet eligibility criteria has significantly amplified the impact of the system.An industry insider stated, “Even applying reductions based on the lowest price alone under the stepwise pricing system would discourage late entrants. By adding unmet criteria into the calculation, the government is effectively blocking late generics from entering the market.”
- Company
- Will Retevmo complete its reimbursement race in Korea?
- by Eo, Yun-Ho May 12, 2026 11:30am
- Retevmo has revived the fading prospects for reimbursement of RET-targeted anticancer drugs in Korea.The drug recently passed the Drug Reimbursement Evaluation Committee of the Health Insurance Review and Assessment Service (HIRA), approximately 5 years after receiving domestic approval in Korea. This achievement comes eight months after it passed the Cancer Disease Deliberation Committee in September last year.Retevmo has faced significant challenges throughout the reimbursement process. It received approval from the Ministry of Food and Drug Safety in March 2022.Subsequently, reimbursement criteria were established in November 2022, and the drug passed the Drug Reimbursement Evaluation Committee in May 2023, confirming its cost-effectiveness.However, in August 2023, the listing was derailed when price negotiations with the National Health Insurance Service (NHIS) broke down. Later, in October 2023, data demonstrating an improvement in overall survival (OS) from Phase III clinical trials was released. Based on this evidence, the company reapplied for reimbursement and has now successfully completed the second round of HIRA-level evaluations.Attention now turns to whether Retevmo can achieve a positive outcome in price negotiations and secure final reimbursement listing.RET mutation is a rare genetic alteration found in approximately 1–2% of patients with non-small cell lung cancer.Currently, Retevmo is the only approved RET-targeted therapy in Korea. Conventional chemotherapy and immunotherapy have shown limitations in terms of response rates and duration of response in this patient population.The US National Comprehensive Cancer Network (NCCN) guidelines recommend Retevmo as a “Preferred Category 1” option for first-line treatment of RET-mutated metastatic NSCLC. This is the highest grade, meeting the highest level of evidence and expert consensus. While it is considered a standard of care immediately upon diagnosis, it remains non-reimbursed in Korea.Of course, even within the global standard of care, many are not reimbursed in Korea. However, the case of Retevmo stands out in that it had already demonstrated cost-effectiveness once yet failed at the negotiation stage, and even after additional clinical evidence, the re-evaluation process has been prolonged.Among the A7 reference pricing countries, Retevmo is reimbursed and used in clinical practice in 6 countries (the US, Germany, Italy, the UK, Switzerland, and Japan), excluding France.
- Company
- Enhertu expands treatment scope into HER2 solid tumors
- by Son, Hyung Min May 11, 2026 09:18am
- The HER2-targeted antibody-drug conjugate (ADC) ‘Enhertu’ is accelerating its expansion into the solid tumor market by broadening its indications in Korea.As Enhertu expands its indications to include first-line breast cancer and second-line gastric cancer treatment, there is growing speculation that treatment strategies for HER2-positive solid tumors may shift toward ADCs.ADC anticancer drug ‘Enhertu’According to industry sources on the 9th, the Ministry of Food and Drug Safety recently approved the expansion of Enhertu’s (trastuzumab deruxtecan) indications to include first-line therapy for HER2-positive metastatic breast cancer and second-line therapy for HER2-positive metastatic gastric cancer.This approval allows Enhertu to be used in combination with pertuzumab as first-line therapy for patients with unresectable or metastatic HER2-positive breast cancer, as well as for patients with HER2-positive gastric or gastroesophageal junction adenocarcinoma whose disease has progressed following trastuzumab-based therapy.Enhertu was previously approved as a second-line treatment for HER2-positive metastatic breast cancer and a third-line treatment for HER2-positive metastatic breast cancer.Enhertu is a next-generation ADC that combines a monoclonal antibody with the same structure as trastuzumab, which binds to specific target receptors overexpressed on the surface of cancer cells, with a highly potent topoisomerase I inhibitor payload via a tumor-selective cleavage linker.An ADC is a novel anticancer drug created by linking an antibody that binds to a specific target antigen on the surface of cancer cells to a drug (payload) with cytotoxic activity via a linker. This therapy has the advantage of enhancing treatment efficacy while minimizing side effects by leveraging the antibody’s target selectivity and the drug’s cytotoxic activity to ensure the drug acts selectively on cancer cells.For over a decade, the THP regimen, which is a combination of taxane chemotherapy, Herceptin (trastuzumab), and Perjeta (pertuzumab), has remained the standard first-line treatment for HER2-positive metastatic breast cancer. However, limitations have been noted, as a significant number of patients experience disease progression within two years, and some are unable to proceed to subsequent treatments.In the DESTINY-Breast09 study, which served as the basis for this approval, the Enhertu and Perjeta combination reduced the risk of disease progression or death by 44% compared to the existing standard THP regimen. The median progression-free survival (PFS) was 40.7 months, an extension of more than one year compared to 26.9 months in the THP group.In terms of response rates, the objective response rate (ORR) in the Enhertu combination group was 85.1%, higher than the 78.6% in the THP group, and the complete response (CR) rate was 15.1%, exceeding the 8.5% in the control group.At the European Society for Medical Oncology Asia Congress (ESMO Asia 2025) held last year, analysis results for the Asian patient population of the trial were also released. An analysis of 346 Asian patients, including those from South Korea, showed that the median PFS in the Enhertu plus Perjeta combination group was 40.7 months, reducing the risk of progression by 45% compared to the THP group’s 24.7 months.Potential shift in gastric cancer treatment strategiesEnhertu’s expansion is not limited to breast cancer. It is also showing potential to improve survival in HER2-positive gastric cancer, an area with long-standing unmet needs, which is raising expectations for a shift toward ADC-based treatment strategies.HER2-positive gastric cancer is considered a prime area of unmet medical need. While the 5-year survival rate for early-stage gastric cancer exceeds 90%, it drops sharply in the metastatic stage. According to national cancer registry statistics, the 5-year relative survival rate for patients with metastatic gastric cancer is only around 6–7%.Nevertheless, the treatment landscape for HER2-positive gastric cancer has remained largely unchanged for a long time since Herceptin plus chemotherapy became the standard first-line treatment in 2010. Although various HER2-targeted therapies have been developed since then, they have failed to demonstrate clinical outcomes in gastric cancer as clear as those seen in breast cancer.In fact, treatment strategies based on Perjeta, Kadcyla (trastuzumab emtansine), and lapatinib have all failed to achieve significant improvements in survival in gastric cancer clinical trials. As a result, HER2-positive gastric cancer has been considered a tumor type with limited responsiveness to HER2-targeted therapy.Amid this context, Enhertu demonstrated an improvement in overall survival (OS) in the second-line treatment of HER2-positive metastatic gastric cancer through the DESTINY-Gastric04 study. In the trial, Enhertu reduced the risk of death by 30% compared to the standard combination of Cyramza (ramucirumab) and paclitaxel, and the median OS was 14.7 months, an improvement over the 11.4 months observed in the control group.Progression-free survival (PFS) was 6.7 months versus 5.6 months, and ORR was 44.3% versus 29.1%, respectively.
- Company
- New drug competitiveness, patient-focused structure is the key
- by Hwang, byoung woo May 11, 2026 09:18am
- As the Korea Drug Development Fund (KDDF) enters its second phase, opinions have emerged that a structural shift, prioritizing higher success rates over simple pipeline expansion, is necessary for future tasks.During the investment review process, voices called for evaluating project quality based on patient population definition, clinical positioning, and biomarker strategies, rather than viewing innovation and commercialization potential as a completely distinguished one.On the 8th, the KDDF held the '2026 Investment Review Committee Workshop' and conducted a panel discussion under the title 'Investment Review that Produces Results: Directions and Choices for National Drug Development Projects."The Korea Drug Development Fund (KDDF) held the '2026 Investment Review Committee Workshop' on the 8th.The panel discussion was moderated by Koh Dae-kyung, Senior Manager at KDDF, with participation from: ▲Professor Sung Hoon Kim of Yonsei University ▲Junghee Lim, Vice President of InterVest ▲Professor Jaeho Cheong of Yonsei Cancer Hospital ▲Taegon Baik, CEO of Arum Therapeutics.Korean drug development, highlighting challenges in clinical trials and capital beyond pipeline countThe discussion began with an evaluation of Korea's competitiveness in drug development. Despite a rapid increase in domestic pipelines, participants discussed why global drug outcomes remain limited and identified the gap between R&D capabilities and actual performance.Panelists agreed that while the quantitative growth of the domestic ecosystem is evident, it must be supplemented by Phase 3 capital, commercialization judgment, and patient-centric development strategies to translate into global success.First, Professor Sung Hoon Kim noted that the domestic ecosystem has grown to an incomparable scale, but cautioned that quantitative expansion does not automatically yield global results. Professor Kim said, "With thousands of pipelines in motion, even if most fail statistically, I believe a global drug will emerge soon," and assessed, "However, for this to be structurally possible, we ultimately need funds capable of supporting Phase 3 trials."InterVest Vice President Junghee Lim noted that the increase in pipelines should be viewed alongside its underlying structure. Lim explained that many projects are likely in early clinical stages, often linked to the rise of university-based venture startups. While acknowledging the advantage of having the most knowledgeable technical experts lead development, Lim questioned whether rigorous eligibility judgments from a commercialization perspective were adequately applied.(from left Koh Dae-kyung, Senior Manager at KDDF, Professor Jaeho Cheong of Yonsei Cancer Hospital , Professor Sung Hoon Kim of Yonsei University From a clinical perspective, 'patient-centric' was presented as a key keyword. Professor Jaeho Cheong suggested that, since the endpoint of drug development is the patient, the approach should shift away from a 'substance-centric' focus toward defining which patient groups, which biomarkers, and which clinical benefits will be achieved. Professor Cheong stated, "We are playing a game of probability regarding patient reachability," and added, "We must move toward a patient-centric, not substance-centric, approach."Professor Cheong added that competitiveness should be viewed based on clinical benefit rather than the number of candidates. This means that a focus on which patient segments to target and what clinical positioning to take must come first to increase the value of thousands of drugs.Role of investment review…balancing innovation and failure ProbabilityFollowing the evaluation of competitiveness, the discussion moved to the roles of the Fund and the Investment Review Committee. Senior Manager Koh Dae-kyung asked which criteria (among global competitiveness, innovation, performance potential, or commercialization potential) should be the primary focus.The discussion focused on the balance between 'selecting projects with high success probability' and 'early screening of projects with high failure probability.' As a project funded by public capital, it cannot focus solely on short-term results, yet it is also inappropriate to delay the verification of development feasibility in the name of innovation.Professor Chung proposed 'Translational Probability,' the likelihood of reaching the patient, as the core criterion for investment review. He explained that the role of public support is not just picking winners but also screening out projects with high failure probability early on."The endpoint of the risky journey of drug development is reaching the patient," Professor Chung explained. "Creating criteria that can quantify, index, and objectify this will be the role of the next generation of the Investment Review Committee." However, considering that the KDDF is at a stage where it must produce results in its remaining period, he acknowledged that the weight of competitiveness and commercialization potential might increase.(from left) Junghee Lim, Vice President of InterVest, Taegon Baik, CEO of Arum TherapeuticsFrom an investor's perspective, competitiveness and success probability were emphasized more heavily. Vice President Lim explained that the committee is composed of experts from various fields to view a single project from multiple perspectives. Lim stated that if a 'Best-in-class' drug is targeted, the proposal must include head-to-head comparisons with competitors, a mechanism of action (MoA) demonstrating competitiveness, evidence-based experimental models, and clinical trial designs.Regarding novel targets, Lim also distinguished between research and development. While a novel target may be a research topic to explore over a long period for academia, a company must produce results within limited resources and time.Future Projects, re-designing support systems to increase clinical success ratesIn the latter half of the discussion, participants deliberated on the direction of support after the current national drug development project and the structure of subsequent projects.Panelists argued that future projects should be designed to increase the clinical success rate, moving beyond simple research funding. Key tasks identified included investment linkage, clinical site matching, platform technology support, and strategies for securing Human Proof of Concept (PoC).Regarding this, CEO Taegon Baik suggested different support methods for discovery and clinical stages. Since the discovery stage is high-risk, it should be linked to corporate strategic investment and joint research. At the same time, national budgets should be more concentrated on clinical programs with high success potential.Professor Kim also proposed a separate track for platform technology support. Unlike individual pipelines, platform technologies have independent value but can appear ambiguous from a private investment perspective, necessitating a dedicated track for public support.Park Yeong min, Director of the Korea Drug Development FundDuring the Q&A session, issues such as securing financial resources for subsequent projects, operating expert advisory groups, public-led risk-sharing systems, and the need for a legal foundation were raised. Attendees suggested that since government budgets alone have limits, there should be linkages with long-term investment funds like the National Pension Service and expanded participation from private capital.Park Yeong min, Director of the Korea Drug Development Fund, stated that securing innovation, balancing evaluation and management, recycling budgets from halted projects, and ensuring the continuity of expert organizations are all tasks to be addressed in subsequent projects."We need to consider how to secure innovation and what evaluation criteria to maintain since public funds are involved," Director Park said. "From a VC's perspective, early exits may be important, while from a developer's perspective, there is a need for support until the end to develop a 'First-in-class' drug."Park added, "There are projects that are discontinued during stage or final evaluations, and we need wisdom on how to reuse those halted budgets. We must prepare in a way that preserves the strengths identified so far while minimizing the weaknesses."
- Company
- Rybrevant reimb delayed in Korea…treatment gap persists
- by Son, Hyung Min May 11, 2026 09:18am
- NSCLC drug ‘Rybrevant’The gap in treatment access continues as discussions on health insurance reimbursement for ‘Rybrevant,’ a treatment for non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, have been postponed again.This mutation is known for its low response rate to conventional EGFR-targeted therapies and for the limited treatment options available. With virtually no alternatives to Rybrevant currently available, reimbursement delays continue to place a financial burden on patients.According to industry sources on the 11th, the Drug Reimbursement Evaluation Committee of the Health Insurance Review and Assessment Service (HIRA) recently issued a redeliberation decision regarding the adequacy of reimbursement for Janssen’s NSCLC treatment, Rybrevant (amivantamab).The DREC evaluated its use as monotherapy for patients with locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations whose disease has progressed during or after platinum-based chemotherapy.Although Rybrevant received regulatory approval in Korea in December 2022, it has yet to obtain reimbursement coverage.In addition, the Cancer Drug Deliberation Committee meetings held in September last year and January this year failed to establish reimbursement criteria for several regimens, including ▲ first-line carboplatin + pemetrexed combination therapy for EGFR exon 20 insertion patients; ▲ first-line lazertinib combination therapy for EGFR exon 19 deletion or L858R mutation patients; and ▲ carboplatin + pemetrexed combination therapy following EGFR TKI treatment.Setbacks in development of exon 20 insertion targeted therapies… Rybrevant remains the only optionEGFR exon 20 insertion mutations are structurally complex and heterogeneous compared to exon 19 deletions or L858R mutations, making drug development particularly challenging.In fact, cases of failed drug development have continued in the global market as well.Takeda’s oral targeted therapy Exkivity (mobocertinib) initially received conditional approval based on an objective response rate (ORR) of 28% in early trials, but was withdrawn after failing to demonstrate improvement in progression-free survival (PFS) in the confirmatory Phase III EXCLAIM-2 study.Development of poziotinib was also halted due to efficacy falling short of expectations and toxicity issues.Amid these challenges, Rybrevant has effectively become the only approved treatment option in this setting.Rybrevant is a bispecific antibody targeting both EGFR and MET. It is designed to inhibit not only EGFR mutations but also MET-driven resistance pathways.In clinical practice, MET-based resistance mechanisms are observed in approximately 10–15% of all patients. This patient group has a relatively poor prognosis, and Rybrevant is therefore considered to offer meaningful potential in terms of long-term survival.Rybrevant shows efficacy as first-line combination therapy… patient burden remainsWhile reimbursement discussions for Rybrevant are delayed, clinical practice is increasingly focusing on the value of first-line combination therapy rather than monotherapy.In the Phase III PAPILLON study, Rybrevant in combination with pemetrexed and carboplatin improved both PFS and ORR compared to chemotherapy. The trial included 308 previously untreated patients with locally advanced or metastatic NSCLC harboring EGFR exon 20 mutations.In this study, median PFS was approximately 11.4 months in the combination group versus 6.7 months in the chemotherapy group.However, since current reimbursement discussions are focused on its use as second-line monotherapy, some observers note a gap between the pace of accumulating clinical evidence and policy application.The continued lack of reimbursement imposes a significant financial burden on patients. Annual treatment costs for Rybrevant without reimbursement are estimated at around KRW 150 million.In particular, since the drug is administered once a week during the first four weeks, the financial burden is concentrated in the early treatment phase. After this initial phase, the dosing schedule switches to every two weeks. However, it is reported that the pharmaceutical company is currently operating a partial cost-support program for the initial treatment phase, thereby reducing the actual financial burden on patients. Under this program, a portion of the drug cost is covered during the first four weeks, and a certain percentage of the cost is also covered during the subsequent maintenance therapy phase.Industry observers suggest that Janssen is placing greater strategic emphasis on its use as a combination therapy, which is gaining traction in clinical practice, rather than focusing solely on its monotherapy reimbursement.Rybrevant is currently being developed in combination with Leclaza to expand into first-line treatment of EGFR-mutant NSCLC, while also broadening the potential for its use in the early treatment stages for Exon 20 insertion mutations.However, while treatment strategies in clinical settings are shifting toward first-line combination therapy, reimbursement discussions remain stuck at second-line monotherapy, highlighting an ongoing disconnect between policy and clinical practice.
- Company
- Hunter syndrome drug Hunterase ICV approved in Peru
- by Lee, Seok-Jun May 08, 2026 01:15pm
- GC Biopharma announced on the 6th that its intracerebroventricular (ICV) Hunter syndrome treatment, ‘Hunterase ICV’, has received marketing approval from Peru’s regulatory authority, General Directorate of Medicines, Supplies and Drugs (DIGEMID).This marks the third overseas approval following Japan and Russia. The company plans to expand into additional countries using its Latin America entry as a foothold.Hunter syndrome is a rare inherited disease caused by a deficiency of the IDS (Iduronate-2-sulfatase) enzyme, leading to the accumulation of glycosaminoglycans (GAGs). It presents with skeletal abnormalities, joint deformities, respiratory and cardiac dysfunction, and cognitive impairment. It is known to occur in approximately 1 in every 100,000 to 150,000 male infants.About two-thirds of patients develop severe forms involving central nervous system damage. As the disease progresses, cognitive decline and behavioral abnormalities emerge, affecting patients’ quality of life and prognosis.Hunterase ICV is administered directly into the brain ventricles once a month. In Japanese clinical trials, it significantly reduced heparan sulfate, a key factor in CNS damage.The company also reported stabilization or improvement in cognitive and developmental functions, with sustained efficacy confirmed in long-term follow-up.Jae-woo Lee, head of R&D at GC Biopharma, said, “Based on long-term clinical data, we will focus on addressing the unmet medical needs of patients with severe Hunter syndrome.”
- Company
- SK bioscience's successful M&A
- by Chon, Seung-Hyun May 08, 2026 01:15pm
- The sales share of SK bioscience’s German contract development and manufacturing organization (CDMO) subsidiary has reached nearly 80%. By deploying funds secured during the COVID-19 pandemic into mergers and acquisitions (M&A), the company has strengthened its financial position and improved its defense against market pressures.According to SK bioscience, on the 7th, IDT Biologika’s first-quarter sales reached KRW 128.3 billion, an 8.5% increase from the same period last year.IDT Biologika is a German biotech company acquired by SK bioscience in 2024. SK bioscience purchased a 60% stake in IDT Biologika, previously held by the German biopharmaceutical firm Klocke Gruppe, through a wholly owned German subsidiary. The total acquisition price for IDT Biologika amounted to KRW 370.0 billion. SK bioscience decided to allocate paid-in capital to a third party, issuing 1,519,543 new shares worth KRW 75.7 billion to the Klocke Gruppe. Consequently, the total cash invested by SK bioscience in the acquisition of IDT Biologika is KRW 294.3 billion.Sales of SK bioscience and IDT Biologika (unit: KRW 100 million, source: SK bioscience) BLUE: SK bioscience, GREEN: IDT BiologikaFounded in 1921, IDT Biologika is a major biotech company operating CDMO businesses in Germany and the United States. It has a track record recognized by more than 10 core drug regulatory agencies, including those in the U.S. and Europe. The company develops processes and analytical methods while producing drug substances (DS) and drug products (DP) across the entire vaccine and biotech spectrum from clinical to commercial stages, employing approximately 1,800 people.IDT Biologika’s performance began to be reflected in SK bioscience’s consolidated financial statements starting from the fourth quarter of 2024. Revenue from IDT Biologika of KRW 111.2 billion was recognized in Q4 2024, and last year it recorded revenue of KRW 465.7 billion.With the inclusion of IDT Biologika’s results, SK bioscience’s revenue surged. In the first quarter of this year, SK bioscience’s revenue expanded more than sevenfold compared to the first quarter of 2024.SK bioscience faced significant fluctuations in performance throughout the COVID-19 pandemic.In 2020, SK bioscience signed a contract manufacturing agreement with AstraZeneca to produce and supply COVID-19 vaccine drug substances and finished products. In the same year, SK bioscience signed a tripartite agreement with the Ministry of Health and Welfare and Novavax to supply the COVID-19 vaccine 'NVX-CoV2373,' beginning full-scale contract manufacturing and supply in 2021.SK bioscience’s sales in the first quarter of 2020 was only KRW 22.7 billion. Then, it jumped nearly fivefold over the year to KRW 112.7 billion in the first quarter of 2021, and then rose to KRW 450.9 billion in the fourth quarter of 2021.However, as the contract manufacturing performance for COVID-19 vaccines dissipated, sales dropped. In the first quarter of 2023, SK bioscience’s sales amounted to KRW 20.6 billion, a 95.4% reduction compared to the fourth quarter of 2021.While sales fell sharply after the end of the pandemic, the M&A strategy successfully minimized the sales gap. In the first quarter of this year, IDT Biologika accounted for 76.1% of SK bioscience’s total sales. IDT Biologika’s sales were more than three times higher than SK bioscience’s separate sales of KRW 40.3 billion.From the fourth quarter of 2024 to the first quarter of this year, IDT Biologika’s cumulative sales reached KRW 705.2 billion, accounting for 72.2% of the parent company's sales.
