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- 2026-05-03 23:15:13
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- Will Columvi be reviewed for reimb by CDDC in OCT?
- by Eo, Yun-Ho Sep 19, 2024 05:48am
- Demand is rising for the reimbursement of ‘Columvi,’ the first bispecific antibody treatment option for lymphoma, in Korea. The Korea Leukemia Patients Organization has requested the CD20-CD3 bispecific antibody for diffuse large B-cell lymphoma (DLBCL) Columvi (glofitamab) be redeliberated at the Health Insurance Review and Assessment Service's Cancer Disease Deliberation Committee meeting that will be held in October. In addition, the organization urged the manufacturer, Roche Korea, to come up with a financial sharing plan to accelerate the drug’s reimbursement listing. “Columvi is a third-line treatment that can be immediately used in situations where death can occur within a few months,” said KIPO, adding, “Patients with diffuse large B-cell lymphoma who have failed two or more lines of treatment strategies are sincerely awaiting Columvi’s prompt health insurance reimbursement listing.” The drug was presented for deliberation to the CDDC last July but failed to make the cut for reimbursement. However, Roche recently submitted an application again for its reimbursement. It remains to be seen if the hopes of the medical community and patient groups for Columvi’s reimbursement listing will be fulfilled this time. Columvi was approved in Korea last December for the treatment of adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL), after two or more lines of systemic therapy. The drug is a third-line treatment option for DLBCL, like Novartis’s chimeric antigen receptor (CAR)-T-cell therapy Kymriah (tisagenlecleucel). The two drugs have different benefits; therefore the choice will likely be based on each patient's condition and circumstance. Columvi demonstrated efficacy in Phase I/II NP30179 trial in 155 patients with relapsed or refractory DLBCL after two or more prior systemic therapies. Results showed that Columvi achieved a complete response (CR) of 40% and an overall response rate(ORR) of 52%. The efficacy was also consistent across all subgroups. The most common adverse event was cytokine release syndrome (CRS). Adding to the encouraging data, at the 2024 Congress of the European Hematology Association (EHA 2024), the company unveiled the results of the Phase III STARGLO study, which demonstrated an improvement in overall survival (OS) with Columvi. The STARGLO study enrolled patients with relapsed or refractory (R/R) diffuse DLBCL who were not eligible to receive an autologous stem cell transplant after one or more prior systemic therapies, or who had received two or more prior systemic therapies. In the primary analysis (median follow-up 11.3 months), Columvi and gemcitabine+oxaliplatin (GemOx) combination significantly improved the primary endpoint of OS with a 41% lower risk of death compared to rituximab+GemOx. Seok Jin Kim, Professor of Hematology and Oncology at Samsung Medical Center, said, "There had been much unmet need in DLBCL for more effective third-line treatment options for patients who fail first-line or experience repeated relapses. We expect the introduction of Columvi to significantly improve the outcomes for patients with relapsed or refractory lymphoma in Korea." Although the drug is non-reimbursed, the drug can be prescribed in various general hospitals in Korea. The drug has passed the drug committees (DCs) of Samsung Medical Center, Seoul Asan Medical Center, Sinchon Severance Hospital, Seoul National University Bundang Hospital, Seoul National University Hospital, Ulsan University Hospital, Korea University Anam Hospital, Wonju Severance Christian Hospital, and Chonnam National University Hwasun Hospital.
- Company
- Reimb for orphan drug 'Welireg' for cancer has been denied
- by Eo, Yun-Ho Sep 19, 2024 05:48am
- An orphan drug, 'Welireg,' for cancer still faces challenges in entering insurance reimbursement coverage. Sources said that MSD Korea is preparing to reapply for reimbursement review of its oral hypoxia-inducible factor 2 alpha (HIF-2α) inhibitor, Welireg (belzutifan), after failing to pass the Cancer Disease Review Committee (CDRC) review last month. MSD Korea filed a reimbursement application in April, and the issue was posted on a national petition platform in May. The petition had received over 50,000 signatures, but the drug did not pass the hurdle of the CDRC review. The analysis suggests that finance will be a determining factor for the outcome. Welireg received an orphan drug designation in South Korea last year for its rare indication to treat von Hippel-Lindau (VHL) disease. It won final approval in May last year. The drug is indicated to treat adult patients with VHL disease who require therapy for associated renal cell carcinoma (RCC), central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors, not requiring immediate surgery. The drug has a mechanism of reducing cell proliferation, new blood vessel growth, and tumor growth-associated HIF-2α targeting gene transcription and expression. The efficacy of Welireg was demonstrated through an open-label Study-004 clinical trial, which involved 61 patients with VHL-associated RCC who had at least one measurable solid tumor localized to the kidney. Enrolled patients had other VHL-associated tumors, including CNS hemangioblastomas and/or pNET. The primary endpoint for the clinical trial was an objective response rate (ORR), evaluated radiologically by independent central review according to RECIST v1.1. Additional efficacy endpoints included duration of response (DoR) and time to response (TTR). The results showed that the ORR for patients with VHL-associated RCC treated with Welireg was 49%. All other responses were partial responses. The treatment has yet to reach the median for DoR. The percentage of patients who continued responding after 12 months was 56%. The median TTR was 8 months. In 24 patients with VHL-associated CNS hemangioblastomas, the ORR was 63%. This group had a 4% complete response rate and a 58% partial response rate. Recently, Welireg also added an indication to treat RCC in the United States. The efficacy of the drug was demonstrated through the LITESPARK-005 clinical trial, which involved advanced RCC that has progressed following PD-1 and/or PD-L1 inhibitor or VEGF-TKI therapies. Based on the results, Welireg improved progression-free survival (PFS) compared to everolimus in patients with RCC that has progressed following PD-1 or PD-L1 immune checkpoint inhibitor or VEGF receptor targeting therapies. The drug also reduced the disease progression and death risk by 25%.
- Opinion
- [Reporter’s View] Benefits of the U.S. Biosecure Act
- by Son, Hyung Min Sep 13, 2024 05:50am
- The US House of Representatives recently passed the Biosecure Act, which includes the US’s biological sanctions against China. The bill will now head to the US Senate for voting and go through a presidential review process for legislation. The Biosecure Act restricts transactions with major Chinese biotech companies that the U.S. Congress deems to pose a threat to national security. The US Congress has categorized the biotechs into 3 groups, A, B, and C. Group A includes 5 companies: BGI, MGI, and Complete Genomics, which are genomic equipment manufacturers and analytical services, and Wuxi AppTec and Wuxi Biologics, which are contract development and manufacturing organizations (CDMOs). Group B includes companies that are under the control of a foreign hostile government, provide equipment or services to companies on the list of biotechnology companies of concern, or pose a risk to U.S. national security, and Group C includes subsidiaries and parent companies associated with companies in Groups A and B that are under the control of a foreign hostile government. The Biosecure Act will be implemented after a grace period until January 2032, but already expectations are rising on how Korean companies can benefit from the Act. In particular, the inclusion of Wuxi Biologics, China's largest CDMO, in the sanctions has raised attention to the opportunity it brings to other domestic CDMOs such as Samsung Biologics, Celltrion, and ST Pharm. Wuxi Biologics is present in China, the US, Ireland, Germany, and Singapore, and employs more than 12,000 people. The company occupied 10% of the global CDMO market last year. In fact, ST Pharm is believed to have benefited from the proposal of the Biosecure Act, signing contracts previously made with China. Last month, the company was also selected to supply a small molecule blockbuster drug that generates trillions of wons in annual sales. However, we cannot have blind faith that domestic companies will reap all the benefits. The market is dominated by leading global CDMOs such as Switzerland's Lonza, the US's Catalent, and Japan's Fujifilm, all of which have their eyes on Wuxi Biologics' pie. Their competitive advantage is quality. Based on their years of experience in signing contracts with global pharmaceutical companies, the companies have been expanding their market. Global CDMOs have strong technical capabilities in early research, manufacturing, and commercial finishing processes. Indian companies that own price competitiveness are also emerging as viable competitors. Currently, India has more than 15,000 drug manufacturing facilities owned by around 3,000 pharmaceutical companies. Of these, it is estimated that at least 100 of which are specialized CDMOs. India has 40% lower drug manufacturing costs than the US and Europe, and has the highest number of US Food and Drug Administration (FDA)-approved pharmaceutical plants outside the US. In other words, to survive, domestic companies need to secure production capacity, quality, and technology, not settle for just a slice of Wuxi Biologics' pie. Global CDMOs have invested in cell gene therapy (CGT) and antibody-drug conjugates (ADCs) to win orders. Currently, domestic CDMOs are still in the investment stage for ADCs and CGTs. In addition, there is also a possibility that the U.S. will extend the protection of its industry and sanction more companies. In 2022, the U.S. administration has implied restricting overseas companies by proposing an executive order to increase domestic production of biopharmaceuticals. Policies aimed at increasing domestic production and protecting its own biotech sector are bound to be a blow to companies looking to enter the US. In this sense, it is not impossible that the knife pointed at China could be extended to other countries. This is where the government’s support comes into play. While the current government has signaled that it sees the bio-industry as a future growth engine and is committed to implementing relevant policies, there is a consensus that the industry has not felt the impact so far. Experts believe that the government needs to continue to support the industry by increasing the scale of government support and providing tax incentives. In the current state, The US Biosecure Act is clearly an opportunity for domestic companies. If the companies continue to seek growth based on their investment and technological capabilities and are supported by the government, they will be able to enter the global market.
- Company
- JAK inhibitor 'Jyseleca' approved for use at 'Big 5'
- by Eo, Yun-Ho Sep 13, 2024 05:50am
- Product photo of Jyseleca. The JAK inhibitor 'Jyseleca' has been successfully introduced to general hospitals. Sources said Jyseleca, the fifth JAK inhibitor in South Korea, has passed the drug committees (DC) of 'Big 5' tertiary hospitals, including Samsung Medical Center, Seoul University Hospital, Seoul St. Mary's Hospital, Seoul Asan Medical Center, and Sinchon Severance Hospital. The drug also passed DC of medical centers, including Kangbuk Samsung Hospital, Korea University Anam Hospital, Cha University Bundang Medical Center, Sejong Chungnam National University Hospital, Ulsan University Hospital, Konkuk University Hospital Chungju Hospital, and Hanyang University Medical Center, as well as national university hospitals in major cities. Considering that it is the fifth approved JAK inhibitor in South Korea, it has quickly become available for prescription at hospitals following reimbursement listing in November last year. Jyseleca’s initial indication for reimbursement was for the treatment of rheumatoid arthritis and moderately to severely active ulcerative colitis. Its reimbursement criteria are set for individuals who have had an inadequate response to conventional therapies or have no drug tolerance to each disease. For those who are over 65 years old, the criteria are set for individuals who have had an inadequate response to TNF-α inhibitors or have no drug tolerance. In South Korea, JAK inhibitors, such as 'Xeljanz (tofacitinib),' 'Olumiant (baricitinib),' and 'Rinvoq (upadacitinib),' are being prescribed. It is to be watched whether Jyseleca would have a competitive advantage over these drugs. Since their launch, these drugs have been expanding indications and reimbursement criteria. Xeljanz additionally secured indications for ulcerative colitis and psoriatic arthritis, and latecomers, such as Rinvoq, are also expanding prescription areas in autoimmune diseases, including atopic dermatitis, Chron’s disease, and ankylosing spondylitis. Since their launch, these drugs have been expanding indications and reimbursement criteria. Xeljanz additionally secured indications for ulcerative colitis and psoriatic arthritis, and latecomers, such as Rinvoq, are also expanding prescription areas in autoimmune diseases, including atopic dermatitis, Chron’s disease, and ankylosing spondylitis. Consequently, patients are expected to have improved treatment options for rheumatoid arthritis. Of course, the use of JAK inhibitors, including Jyseleca, will substantially increase. According to the market research firm UBIST, the JAK inhibitor outpatient prescription market size for the first half of 2023 was KRW 27.5 billion, up by 54% from KRW 17.8 billion year over year. Meanwhile, Jyseleca is a selective ATP-competitive and reversible JAK1 inhibitor. JAK1 transmits signals from a cytokine, and it is regarded as the key target for the treatment of rheumatoid arthritis. Recently launched treatments inhibit JAK2 or JAK3, depending on their mechanism. However, there are concerns that adverse reactions may occur, as two signaling pathways regulate immune cell proliferation and homeostasis. The FINCH1, FINCH2, and FINCH3 Phase 3 trials have demonstrated the effectiveness of Jyseleca. In the FINCH1 trial, Jyseleca 200 mg treatment in patients with moderately to severely active rheumatoid arthritis reached ACR20 at 20 weeks more quickly despite continued treatment with MTX.
- Policy
- Moderna’s COVID-19 vaccine is approved in Korea
- by Lee, Hye-Kyung Sep 13, 2024 05:50am
- A new COVID-19 variant vaccine, which is the only mRNA-based COVID-19 vaccine that will be manufactured domestically (by Samsung Biologics) has been approved in Korea. The Ministry of Food and Drug Safety (MFDS, Minister: Yu-Kyoung Oh) announced on the 11th that it has authorized the manufacturing and sale of ‘Spikevax JN.1’ that Moderna Korea applied for. Like Pfizer's COVID-19 vaccine, which was approved on August 30, Spikevax JN.1 is a vaccine that contains an mRNA designed to express the JN.1 variant antigen as the active ingredient. It is indicated for the prevention of COVID-19 in persons 12 years of age and older and is administered as a single intramuscular injection of 0.5mL. Those who have previously received a COVID-19 vaccine should administer Spikevax JN.1 at least 3 months after his or her most recent COVID-19 vaccination. Samsung Biologics will receive the active pharmaceutical ingredient supplied by Moderna and manufacture the finished drug through filling and labeling, and its domestic manufacture is expected to ensure a smooth supply of the vaccine. The Ministry of Food and Drug Safety said, ‘While strictly examining the safety, effectiveness, and quality of this vaccine, we worked to promptly approve the drug in 2 months so that there would be no disruption to the National Immunization Program for high-risk groups that are scheduled to begin next month.”
- InterView
- ‘Era of once-weekly growth hormones…adherence is key’
- by Hwang, Byung-woo Sep 13, 2024 05:49am
- "The frequency of drug administration is an important factor in the treatment of growth hormone deficiency. The emergence of a once-weekly dosing option is significant in terms of treatment adherence.’ With the market for growth hormone injections rising rapidly, the diversified treatment options have been increasing market interest. The introduction of once-weekly treatment options to the once-daily regimen has emphasized the importance of choosing the right treatment option for patients. Professor Masanobu Kawai (Osaka Women's and Children's Hospital( focused on the effect of the once-weekly growth hormone deficiency treatment. Professor Masanobu Kawai, Osaka Women Growth hormone deficiency is a condition in which the pituitary gland, which is responsible for the secretion of hormones in the body, does not produce enough growth hormone, and is defined as a serum peak growth hormone concentration of less than 10 ng/mL in two or more growth hormone provocation tests. According to the Health Insurance Review and Assessment Service, the number of Korean patients under the age of 19 diagnosed with growth hormone deficiency has nearly doubled over the past 5 years, from 9,746 in 2019 to 19,363 in 2023. The main treatment method is the administration of growth hormone therapy, and once-daily administration has been the main option. In September last year, Pfizer's once-weekly growth hormone deficiency treatment Ngenla (somatrogon) was approved for reimbursement, expanding the options available. Professor Masanobu, who has more experience prescribing Angela as the drug was first released in Japan than in Korea, explained that Ngenla offers a big difference in terms of treatment adherence. Professor Masanobu said, “As a once-daily growth hormone therapy, Ngenla’s approved dose is higher in Korea than in Japan. In Japan, we had concerns about the efficacy of the approved daily treatments due to their low dose, but the once-weekly treatments with higher doses have shown a clear effect.” He added, “Ngenla has strengths in terms of treatment adherence, which is an important factor in growth hormone therapy. Patients with growth hormone deficiency are typically prescribed every 3 months, and patients who are prescribed daily growth hormone therapy have more injections left over at the time of their visit.’ This means that the convenience of a once-weekly treatment, compared to a daily treatment, leads to higher adherence. This convenience is expected to reduce the burden of administration on patients and caregivers. In fact, according to a survey on growth hormone deficiency patients and their parents in Japan, 44% responded that the frequency of dosing was the most important aspect they consider when using growth hormone therapy. “This finding, which was identified before the introduction of Ngenla, demonstrates the inconvenience patients felt due to the frequent administration of existing therapies. A once-weekly dosing regimen is convenient and could ease the burden of treatment for patients and their parents,” explained Professor Masanobu The hurdle of the once-weekly dose is ‘pain’...‘Most patients would prefer less frequent dosing’ However, there is also a hurdle for once-weekly treatments. While they are less burdensome to administer than their competitors that require daily injections, there is still the issue of pain management that follows the use of injectables. On this, Professor Masanobu said that the long-acting injectables may bring a higher pain burden due to the higher dose, but this can be addressed by adjusting the injection site. “Once-daily treatments use thin, short needles, but Ngenla uses thicker, longer needles because of the higher dose. If the needle is injected deep enough to reach the subcutis, the injection pain can be absorbed by the surrounding tissues, reducing the burden.’ However, South Korea's approach to pain management differs from Japan's in that it uses a single injection. Nevertheless, Professor Masanobu believed that Ngenla’s less frequent administration is likely to be preferred by most patients other than the younger patients for whom pain management is a priority. In addition, Professor Masanobu believes that the emergence of a once-weekly dosing option for growth hormone deficiency treatment could lead to improvements in the patient and parents’ quality of life (QOL) beyond therapeutic effect. Professor Masanobu said, “In terms of efficacy, the once-daily and once-weekly doses may have similar effects, however, the burden of daily dosing can affect a person's life in general. Considering the pressure felt by patients and parents, as well as treatment adherence, the ability to alleviate this burden is one of Ngenla’s greatest advantages.’
- Company
- Global guidelines recommend Leclaza combination therapy
- by Son, Hyung-Min Sep 13, 2024 05:49am
- Leclaza plus Rybrevant combination therapy has been listed as a first-line therapy in global guidelines after demonstrating improvements in survival rates. Leclaza plus Rybrevant combination therapy, which is the new treatment for epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC), received U.S. Food and Drug Administration (FDA) approval as a first-line therapy last month. This combination therapy showed statistically improved progression-free survival (PFS) and overall survival (OS) than Tagrisso monotherapy. Leclaza plus Rybrevant combination therapy has been listed in the NCCN guideline…demonstrated clinical effectiveness Product photos of YuhanSources said on September 12th Leclaza plus Rybrevant combination therapy has been recommended by the National Comprehensive Cancer Network (NCCN) as a first-line therapy based on its recent clinical effectiveness. As a result, the combination therapy now has an expert assessment that it can be used as a first-line therapy for treating NSCLC harboring mutations of EGFR in exon 19 and exon 21. The NCCN provides guidelines recommending cancer diagnosis, treatment, and prognosis. It is an alliance of 33 centers, including the U.S. National Cancer Center and research centers. Physicians worldwide use the NCCN as the primary cancer diagnosis and treatment guideline. As the NCCN recommends Leclaza plus Rybrevant combination therapy, its presence as a first-line therapy is expected to be expanded. Until now, the NCCN and other guidelines have recommended Tagrisso monotherapy, a third-generation tyrosine kinase inhibitor (TKI) targeting exon 19 and exon 21, for the treatment of NSCLC harboring EGFR mutations. However, Leclaza, the third-generation TKI like Tagrisso, and Rybrevant, targeting mutation in EGFR exon 20, have shown more effective results than Tagrisso monotherapy. This indicates a potential change to the major cancer treatment guidelines. The OS results of Leclaza plus Rybrevant combination therapy are suggested to be the key to commercialization. Moreover, inclusion in the NCCN guidelines is a significant achievement. Leclaza plus Rybrevant combination therapy shows continual benefits…3-year OS follow-up data have been disclosed Leclaza plus Rybrevant combination therapy is listed in the NCCN due to its proven effectiveness results. In terms of interim OS analysis, Leclaza plus Rybrevant combination therapy showed superior benefits than Tagrisso. These clinical results were from the Phase 3 MARIPOSA study, which was disclosed during the European Society for Medical Oncology (ESMO) conference and the annual World Conference on Lung Cancer (WCLC) conference. The clinical trial compared the effectiveness and safety of Leclaza plus Rybrevant combination therapy to Tagrisso monotherapy. The patients were randomly assigned at a 1:1 ratio to either the Leclaza plus Rybrevant combination therapy group (429 individuals) or the Tagrisso group (429 individuals). The clinical trial showed that 61% of the Leclaza plus Rybrevant combination therapy group had a three-year OS rate, which was higher than 53% of the Tagrisso monotherapy group. 75% of the Leclaza plus Rybrevant combination therapy group had a two-year OS rate, whereas 70% for the Tagrisso group. Leclaza plus Rybrevant combination therapy shows continued benefits than Tagrisso monotherapy in terms of the overall survival (OS) rate. The median follow-up of 31.1 months showed that 155 patients of the Leclaza plus Rybrevant combination therapy group had a disease progression and discontinued further treatment, whereas 233 patients of the Tagrisso group discontinued further treatment due to disease progression. Then, the patients received follow-up therapies using chemotherapy, such as Alimta (pemetrexed) plus carboplatin. The second PFS (PFS2) measurement showed that the Leclaza plus Rybrevant combination therapy group had a significantly longer median time between treatment discontinuance and follow-up therapy than the Tagrisso group. Additionally, Leclaza plus Rybrevant combination therapy showed positive results for the intracranial PFS, which is an indicator for brain metastasis. The results showed that the median PFS, which was set as the primary endpoint, for Leclaza plus Rybrevant combination therapy was 23.7 months. The Leclaza monotherapy group had a median PFS of 18.5 months, longer than 16.6 months for the Tagrisso monotherapy group. Leclaza plus Rybrevant combination therapy also reduced the disease progression and death risk by 30% compared to the Tagrisso group. The PFS2 results showed that the Leclaza plus Rybrevant combination therapy group had a 25% lower disease progression and death risk than the Tagrisso monotherapy group. Researchers stated, "Leclaza plus Rybrevant combination therapy is showing improvements in the outcomes of disease progression as well as OS than Tagrisso monotherapy," adding, "We have confirmed Leclaza plus Rybrevant combination therapy is a first-line standard therapy for EGFR-mutated advanced NSCLC."
- Company
- Hugel offers guide to safe injection of dermal fillers
- by 어윤호 Sep 12, 2024 04:16pm
- Dr. Jung Jae Eun, the medical director of DICARATCLINIC in Seoul, performs a live demonstration of injection of dermal filler The ChaeumHugel Inc., a leading global medical aesthetics company, said on Thursday it hosted The Chaeum Safe-tech Session (TSS) seminar for injection of dermal fillers for some 20 medical experts in Seoul on September 11 to improve their understanding of safe treatment and Hugel’s hyaluronic acid filler brand The Chaeum. The lecture covered anatomical knowledge of filler administration in key facial areas and critical points that practitioners should be aware of. Following the lecture, Seoul-based DICARATCLINIC’s Medical Director Jung Jae Eun performed a live demonstration focusing on injecting techniques for nasolabial folds, forehead, cheeks and lips and explained the importance of safe filler injection. Dr. Jung, advisor on The Chaeum, has extensive experience in filler injection and uses more than 3,000 syringes of The Chaeum a year. She highlighted providing safe and professional medical services and strengths of The Chaeum fillers in the seminar. “We are very pleased to have successfully hosted the seminar with The Chaeum advisor Dr. Jung to meet medical aesthetics professionals and share knowledge and skills. Hugel will continue to host academic events for proper use of fillers,” a Hugel official said. “Diagnostic accuracy and delicate skills are essentials for effective filler injection. With Hugel, we will strive to promote knowledge and skills in the use of The Chaeum which has proven its safety for over the past 10 years in the market,” Dr. Jung said.
- Company
- Yuhan earns ₩80B milestone with Leclaza's FDA nod
- by Chon, Seung-Hyun Sep 12, 2024 05:51am
- On the 11th, Yuhan Corp announced that it will receive USD 60 million (approximately KRW 80 billion) as milestone payments from Janssen Biotech for Leclaza. View of Yuhan Corp headquarters The company explained, “This is a milestone payment (step-by-step technical fee) for the commercialization of Leclaza and Janssen Biotech's amivantamab combination therapy.” The US Food and Drug Administration (FDA) has approved Yuhan Corp’s Leclaza in combination with Rybrevant for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations. With the approval, Leclaza became the first homegrown new anticancer drug to receive US approval. Leclaza is a non-small cell lung cancer treatment approved as the 31st domestically developed new drug in January 2021. Yuhan Corp succeeded in passing the US market gateway 6 years after licensing out Leclaza to Janssen Biotech in November 2018. In November 2018, the company received a USD 50 million upfront payment for Leclaza. In April 2020, the company received a USD 35 million milestone payment from Janssen. Johnson & Johnson paid the additional milestone to the company when it initiated the clinical trial for the Rybrevant and Lexarza combination. In November 2020, Johnson & Johnson paid an additional milestone of USD 65 million to Yuhan Corp as it began recruiting subjects for the trial. Additional milestone payments followed upon successful completion of the trial and FDA approval. In total, Yuhan Corp has earned a total of USD 210 million (KRW280 billion) in technology fees since licensing out Leclaza’s technology.
- Company
- HK inno.N signs supply deal with Pfizer for COVID-19 vaccine
- by Son, Hyung-Min Sep 12, 2024 05:51am
- (from left) Pfizer Korea CEO Oh Dong-wook and HK inno.N CEO Kwak Dal-won. HK inno.N announced on September 11th that it has signed an agreement with Pfizer Korea for the domestic distribution of the new COVID-19 vaccine. On September 10th, two companies held an agreement ceremony celebrating the strategic collaboration for the distribution of Pfizer Korea's COVID-19 vaccine, 'Comirnaty JN.1 Inj (bretovameran),' which is a SARS-CoV-2 Spike Protein encoded messenger Ribonucleic Acid. Attendees for the agreement ceremony included HK inno.N CEO Kwak Dal-won, Pfizer Korea CEO Oh Dong-wook, and employees who have contributed to the deal from both companies. Upon the agreement, HK inno.N will be responsible for the domestic distribution of Pfizer's new COVID-19 vaccine for the general public, excluding high-risk groups (people aged 65 and older and the immunocompromised individuals) eligible for the National Immunization Program. 'Comirnaty JN.1 Inj' is an mRNA vaccine designed to produce antigen against COVID-19's JN.1 variant. It is administered as a single intramuscular injection of 0.3 mL without dilution to prevent COVID-19 caused by the SARS-CoV-2 virus in individuals over 12 and older. Comirnaty JN.1 Inj was approved in South Korea on August 30th. HK inno.N CEO Kwak Dal-won said, "With the recent rise in COVID-19 infection numbers, we plan to swiftly supply COVID-19 vaccines through our distribution partnership and contribute to public health." Pfizer Korea CEO Oh Dong-wook said, "We are pleased to have signed an agreement with HK inno.N, a company with broad-spectrum know-how of vaccine supply and years of experience," adding, "Through close collaboration among companies to supply COVID-19 vaccines to the market, we can help more patients receive immunization."
