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- 2025-12-23 06:57:35
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- Pfizer expands co-marketing partnership deals
- by Son, Hyung-Min Apr 03, 2024 05:50am
- Pfizer Korea will co-market 2 blockbuster autoimmune disease drugs with a local drug distributor Hanlim MS. Pfizer has signed copromotion deals with Jeil Pharmaceutical, Donghwa Pharm, and Chong Ku Dang, but this is the first time the company has signed a co-marketing partnership deal with Hanlim MS. The company explained that it decided to partner with Hanlim MS because it owns various capabilities in distribution and supply in the field of autoimmune disease treatment. Autoimmune disease treatment Enbrel According to industry sources on the 3rd, Pfizer announced that it will co-market its autoimmune disease drug Enbrel with Hanlim MS. This is the second agreement the companies have made, following the co-marketing agreement of Janus kinase (JAK) inhibitor Xeljanz in January. Previously, Pfizer distributed and marketed both drugs directly, and this is the first time the company decided to comarket the two drugs. Pfizer has continuously been forging co-promotion partnerships with domestic pharmaceutical companies. It is comarketing the antidepressant Pristiq Donghwa Pharm, and the pneumococcal vaccine Prevenar with Chong Kun Dang. Viatris, which was spun off from Pfizer in 2020, is selling Lipitor, Celebrex, and Lyrica with Jeil Pharm. However, 2 autoimmune disease drugs will be sold by Hanlim MS, a subsidiary of Hanlim Pharm. Pfizer is said to have positively evaluated the synergies in terms of business strategy with Hanlim MS's nationwide distribution network. Hallim MS is a direct pharmaceutical distributor Hanlim Pharm established through a spin-off in 2008. Hallim MS generates 100% of its revenue from product sales. The company has been recognized for having a nationwide distribution network with many years of accumulated know-how since establishing an internal sales organization in 2010. This year, Hanlim MS has upscaled its rheumatology business unit to a division level and started to expand its business in earnest. Pfizer Korea had signed a comarketing agreement with Hanlim MS for Xeljanz in January last year Hanlim MS has been expanding its business in various other sectors in addition to pharmaceuticals. In 2022, Hanlim MS signed a memorandum of understanding with OpenM, a medical device company, and FNA Medical, a medical device wholesaler, for ‘OpenCast (cast).’ In 2021, Hanlim Pharm also secured the domestic sales rights for an Eylea biosimilar, a macular degeneration treatment, with Altos Biologics, a subsidiary of domestic biotech company Alteogen. Alteogen is currently conducting a global Phase III clinical trial for its candidate drug. Pfizer Korea said, “Hanlim MS owns a broad range of capabilities and know-how in distribution and supply of pharmaceuticals including immune-mediated inflammatory disease therapies, and has a long-standing partnership with rheumatologists, so we expect our partnership to bring great synergies.”Sales of Enbrel-Xeljanz on a decline...will the partnership with Hanlim MS bring synergistic effect Pfizer Korea plans to expand sales through the co-marketing agreement with Hanlim MS. Currently, sales of Enbrel and Xeljanz are declining due to the emergence of competing products. Enbrel, which was approved in Korea in 2003, has 6 indications - adult rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis (ankylosing spondylitis, radiographically unidentified axial spondyloarthritis), psoriasis, and juvenile idiopathic arthritis. However, its sales have been on a decline due to the rise of biosimilars and additional biologics. According to market research firm IQVIA, Enbrel's sales have declined for 5 consecutive years after posting sales of KRW 12.9 billion in 2019. Last year, the drug failed to reach the KRW 10 billion sales mark and posted KRW 9 billion in sales. Companies that have launched biosimilars have been steadily gaining a bigger slice of the market pie. LG Chem's Eucept posted sales of KRW 4.4 billion last year, up 8.8% year-on-year. Its sales volume has been gradually increasing since posting KRW 1.2 billion in 2019. Samsung Bioepis' Etoloce’s sales dropped 13.8% from KRW 4 billion in 2022 to KRW 3.5 billion last year. Etoloce has consistently recorded sales of more than KRW 3 billion since 2019. In addition to Enbrel, sales of Xeljanz, which is being jointly sold by Pfizer Korea and Hanlim MS, have also been on a decline. Xeljanz was the first oral JAK inhibitor approved for the treatment of rheumatoid arthritis and was approved in South Korea in 2014. It is currently approved for the treatment of rheumatoid arthritis, ulcerative colitis, psoriatic arthritis, ankylosing spondylitis, polyarthritis, juvenile idiopathic arthritis, and juvenile psoriatic arthritis. However, sales of Xeljanz have been declining due to the emergence of competitors such as Rinvoq, Olumiant, and Jyseleca. Last year, Xeljanz generated sales of KRW 12.9 billion, down 4.4% from 2022. This is the third consecutive year of declining sales for Xeljanz, after posting KRW 16.2 billion in 2020.
- Company
- Kukje Pharm and Celltrion will comarket Eylea biosimilar
- by Nho, Byung Chul Apr 03, 2024 05:50am
- Celltrion CEO Young-ho Yoo (left) and Kukje Pharm CEO Tae-hoon Nam is posing for a commemorative photo after signing the MOU. By taking in Celltrion's Eylea biosimilar, Kukje Pharm has further strengthened its position in the domestic ophthalmic disease treatment market. On the 2nd, Kukje Pharm announced that it has entered into a strategic marketing partnership agreement with Celltrion to commercialize CT-P42 (Eylea biosimilar, aflibercept), an ophthalmic retinal disease treatment developed by Celltrion, in Korea. Under the agreement, Celltrion will exclusively distribute CT-P42 in Korea to Kukje Pharm, and Kukje Pham will provide patients with access to the high-quality biologic drug in Korea by taking charge of its domestic sales and distribution as soon as CT-P42 is approved by the Ministry of Food and Drug Safety in Korea. Eylea, which was developed by the US company Regeneron, binds to vascular endothelial growth factor (VEGF) receptors and inhibits neovascularization. It is used to treat ophthalmic retinal diseases such as neovascular (wet) age-related macular degeneration, diabetic macular edema, macular edema following retinal vein occlusion, and vision impairment due to choroidal neovascularization by Among them, wet macular degeneration causes abnormal new blood vessels to grow underneath the macula, which expands and can produce hemorrhage, edema, and damage to the retina and macula, leading to decreased vision and even blindness. It has recently been recognized as one of the top 3 causes of blindness in people over 65 years of age. Eylea’s annual global market sales amount to approximately USD 1.3 billion and is about KRW 97 billion in Korea and sales with the growing number of patients with macular degeneration. Kukje Pharm already has a diverse product lineup in the field of ophthalmic disease treatments and has recently established itself as a strong player in the ophthalmic disease market with the successful launch of its new and improved drug ‘Reba-eye Eye Drops'. The partnership is expected to enhance the company's competitiveness in the market by adding the Eylea biosimilar to its existing lineup of various ophthalmic disease treatments, including Reba-eye Eye Dropgs, Cualone Eye Drops, and Retium Tab. Both companies expect the partnership to provide patients with broader treatment options in the domestic ophthalmic disease therapeutics market. A Kukje Pharm official said, "This agreement further strengthens our position in the ophthalmic therapeutic area and enables us to provide patients with more effective treatment options through the domestic sales of CT-P42. We plan to leverage our company’s existing marketing and distribution network to ensure the successful launch of CT-P42."
- Company
- K-Bio accelerates solid cancer trials with ‘new MOA’ CAR-T
- by Son, Hyung-Min Apr 02, 2024 05:54am
- The Korean pharmaceutical and biotechnology industry aim to introduce solid cancer-targeting CAR-T with new mechanisms of action (MOA). Chimeric antigen receptor T (CAR-T) cell therapy is an immune cell therapy for cancer treatment designed to deliver genetic material to T cells to produce the CAR in patients. CAR-T has not been approved for indications in solid cancer because the tumor microenvironment, such as fibroblasts in tumor tissues, limits T-cell modifying CAR-T from T-cell infiltration, posing barriers to discovering target antigens. All of the commercialized treatments, including Novartis’ Kymriah, Gilead Science’s Yescarta, and BMS’ Breyanzi, have been approved for blood cancers. To overcome these challenges, Korean companies are developing differentiated strategies, such as targeting mesothelin that can adhere to the cells and aid in signaling or new technology platforms. According to industry sources on the 29th, HK inno.N, GC Cell, AbClon, and Vaxcell-Bio are conducting clinical trials for CAR-T therapy to treat solid cancer. HK inno.N. HK inno.N and CellabMED, a Korean biotechnology company, are developing CAR-T therapy for treating solid cancer. Earlier this month, these companies signed a joint-research agreement to collaborate on new drug development throughout all phases, including research, production, and business development. CellabMED, a biotechnology company, specializes in developing innovative anticancer drugs based on antibody therapy and CAR-T therapy. The company’s CLM-103, a candidate CAR-T targeting glioblastoma, has received IND approval to target solid cancer for the first time in South Korea. HK inno.N is developing CAR-T therapy using T-cells expressing an antibody that inhibits the immune gateway factor ‘HLA-G’ as their inhouse research. HLA-G overexpression on certain cancer cells can disrupt the immune system in the body. HK inno.N’s CAR-T therapy has been selected as a national drug development support project, and it aims to start clinical trials. GC Cell. GC Cell is developing a CAR-T therapy targeting MSLN (mesothelin), primarily overexpressed in solid tumors. Mesothelin is gaining attention as a target for cancer antigen, with expression rates of 85-90% in mesothelioma, 80-85% in pancreatic cancer, and 60-65% in ovarian cancer and lung cancer. In preclinical studies, GC Cell confirmed the anticancer activity in experiments targeting pancreatic cancer tissue transplanted animals. Additionally, no side effects related to the target or non-tumor toxicity were observed. AbClon. AbClon is developing a candidate CAR-T therapy, AT501, for patients with solid tumors. AT501 is a switchable CAR-T therapy candidate targeting HER2-positive solid tumors. AbClon's in-house research has developed this therapy by applying existing CAR-T technology to a switch molecule that combines an artificial protein binding to HER2-responsive specific targets and cotinine. AbClon has developed the switchable CAR-T platform (zCAR-T). It is a next-generation technology that uses cotinine switch molecules to regulate CAR-T activity, addressing issues found in conventional therapies, such as toxicity, resistance, and disease expansion. According to the company, the zCAR-T platform is an improved technology that requires switch molecules to attack cancer cells rather than developing CAR-T cells that directly target specific proteins on the surface of cancer cells. This approach has the advantage of activating and proliferating CAR-T cells and altering target molecules using switch molecules. Vaxcell-bio. Vaxcell-bio is developing ‘VaxCAR2301.’ It is a novel candidate CAR-T therapy that simultaneously targets PD-L1 and EphA2. According to the company, when using the single-chain antibody fragment (scFv) of the immune checkpoint inhibitors avelumab and atezolizumab, which target PD-L1, in immune cell production, either non-dissociation or slow dissociation after cancer cell death can occur, resulting in excessive cytokine storms. The company addressed this issue by reducing the affinity of the antigen-binding site, which binds to antibodies, to a moderate level. In preclinical studies, VaxCAR2301 demonstrated a CAR expression rate reaching 78% in CD8-positive cytotoxic T cells. This is significantly higher than the 58% for avelumab CAR-T and 45% for atezolizumab CAR-T. Additionally, treatment with VaxCAR2301 led to controlled tumor size, rapid weight recovery, and an extended survival period until the end of the experimental observation.
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- PharmaEssentia reattempts reimb of BESREMi in Korea
- by Eo, Yun-Ho Apr 02, 2024 05:53am
- PharmaEssentia is again attempting to list BESREMi, its new drug for polycythemia vera (PV), for reimbursement in Korea. Dailypharm’s coverage found that the Taiwanese pharmaceutical company PharmaEssentia has recently resubmitted an application for the reimbursement of BESREMi (Ropeginterferon alfa-2b) in Korea. The company had submitted an application for the reimbursement of its drug in March last year as a treatment for patients with polycythemia vera resistant or intolerant to hydroxyurea but failed to clear the hurdle of Korea’s Health Insurance Review and Assessment Service’s Cancer Disease Review Committee in July of the same year. At the time, the CDDC determined that there was insufficient evidence to determine the clinical usefulness of BESREMi as a second-line treatment. This time, PharmaEssentia included additional domestic clinical data on BESREMi to supplement the drug’s evidence of efficacy as a second-line treatment. As 50,000 people signed the National Assembly’s public petition requesting the ‘reimbursement of BESREMi’ in February, whether the drug will be reimbursed this time is gaining more attention. BESREMi is a next-generation interferon treatment that selectively removes JAK2 mutations that cause polycythemia vera. It offers an improved purity and tolerability over existing interferons so that it can be administered every 2 weeks for the first 1.5 years and every 4 weeks thereafter. Currently, BESREMi is recommended for the treatment of PV in the National Comprehensive Cancer Network (NCCN) and European Leukemia Network (ELN) guidelines, regardless of prior treatment history. Polycythemia vera is a rare blood disorder where a somatic cell mutation in the bone marrow abnormally activates bone marrow function and produces excessive red blood cells. According to HIRA data, around 5,000 patients are affected with PV, and hydroxyurea is used for the majority of patients. However, the current reimbursed drugs cannot cure PV, and no new alternatives exist for patients who fail treatment with hydroxyurea, leaving the patients with a high unmet need.
- Company
- Oral option introduced for psoriasis in Korea
- by Eo, Yun-Ho Apr 01, 2024 05:29am
- Oral treatment options are trending in the field of psoriasis. Therefore, It remains to be seen whether the market, which is currently dominated by biologic drugs, will shift in the future. The frontrunner in the field is BMS Pharmaceutical Korea's TYK2 inhibitor Sotyktu (deucravacitinib). The drug, which is a treatment for plaque psoriasis with a novel mechanism of action, has been approved in Korea and will be covered by reimbursement from next month (April). Sotyktu is a first-in-class, selective TYK2 inhibitor. TYK2 is a critical intracellular transduction link between interleukin (IL)-23 and the production of IL-17, which is known to play a central role in the pathogenesis of psoriasis. Sotyktu has gained attention as the first oral treatment option in this indication in more than a decade. The drug's efficacy was demonstrated through the Phase 3 POETYK PSO-1 and POETYK PSO-2 clinical trials, which evaluated the safety and efficacy of Sotyktu compared to placebo and twice-daily Otezla(apremilast) in 1,684 patients aged 18 years and older with moderate-to-severe plaque psoriasis. In the POETYK PSO-1 trial, 58.4% of patients on Sotyktu achieved a PASI 75 response at week 16, which was significantly higher compared with the 35.1% of patients on Otelza and 12.7% of patients on placebo. Also, the proportion of patients achieving sPGA 0/1 was significantly higher, at 53.6% compared with 32.1% in patients on Otelza and 7.2% in patients on placebo. Sotyktu also achieved a significantly higher PASI 75 response at week 16 in the POETYK PSO-2 trial as well, with 53.0% of patients on Sotyktu achieving a PASI 75 response at week 16, compared with the 39.8% of patients on Otelza and 9.4% of patients on placebo. Another drug that has shown promise is Johnson&Johnson's candidate drug ‘JNJ-2113.’ The results of the Phase IIb trial on the oral plaque psoriasis treatment JNJ-2113 were first presented recently at the American Academy of Dermatology (AAD) Annual Meeting. Study results showed that patients treated with JNJ-2113 maintained improvement in skin lesions caused by plaque psoriasis for nearly a year. JNJ-2113 is an oral interleukin (IL)-23 receptor antagonist and has a different mechanism of action from Sotyktu. Sotyktu acts on TYK2, which acts as a key link in IL-23 and IL-17 signaling, a major pathway that causes psoriasis, JNJ-2113 directly inhibits the IL-23 receptor peptide. The study presented at the AAD meeting builds on the 16-week treatment results published last July and expands the analysis to include 5 different dosing regimens of JNJ-2113. The results confirmed that the JNJ-2113 treatment group met both the primary and key secondary endpoints. Yong-beom Choe, President of the Korean Society of Psoriasis, said, "When considering how no options other than injectable biologics were available until now, the oral formulations may address the unmet needs in the treatment of psoriasis based on its convenience in dosing.”
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- AZ’s Sidapvia can be prescribed in general hospitals in KOR
- by Eo, Yun-Ho Mar 29, 2024 05:53am
- The diabetes combination drug Sidapvia can now be prescribed in general hospitals in Korea. According to industry sources, AstraZeneca Korea's Sidapvia (dapagliflozin-sitagliptin), which is a combination of its SGLT-2 inhibitor ‘Forxiga’ and DPP-4 inhibitor ‘Januvia’, has passed the drug committees(DCs) of around 30 medical institutions in Korea, including tertiary hospitals such as Samsung Medical Center, Seoul National University Hospital, and Sinchon Severance Hospital. As the company signed a copromotion agreement with HK Inno.N this year, what kind of synergy will be created through the partnership remains to be seen. According to the Korean Diabetes Association's guidelines, SGLT-2 inhibitors and DPP-4 inhibitors work through different mechanisms of action and have a greater glycated hemoglobin reduction effect when combined than when administered alone. Also, previous studies in patients with type 2 diabetes have shown that the combination of dapagliflozin and sitagliptin has a favorable efficacy and safety profile compared with monotherapy. In a study published this year in Springer Nature, the dapagliflozin-sitagliptin-metformin triple combination drug showed a 30% greater glycated hemoglobin reduction effect compared to the dapagliflozin-metformin combination and an approximately 35% greater effect than the sitagliptin-metformin combination. At week 16, the rate of patients reaching the target glucose range from baseline was 38.5% for the triple combination therapy group that used dapagliflozin, higher than the dapagliflozin-metformin combination group and the sitagliptin-metformin combination group. The mean weight loss from baseline at week 16 was significantly greater in the triple combination group with dapagliflozin than in the sitagliptin-metformin combination. Kyung-Wan Min, professor of endocrinology at Nowon Eulji Medical Center, said, "Although many new combination drugs are being introduced to the market for type 2 diabetes, there remains an unmet medical need for patients with type 2 diabetes. As Sidapvia has shown verified clinical outcomes such as significant glycemic reduction and additional weight loss, we expect patients will be able to manage their diabetes and complications better with its more effective glycemic control effect. Meanwhile, HK Inn.N signed a copromotion agreement with AstraZeneca for Sidapvia in October last year. In January, the co-promotion agreement was extended to include Xigduo (dapagliflozin-metformin). At the same time, HK Inno.N also agreed to take over the domestic supply and distribution of the single-agent drug Forxiga. AstraZeneca Korea decided to withdraw Forxiga from the domestic market late last year. HK Inno.N will be responsible for the domestic supply of Forxiga until the second half of this year. Both companies have expressed their commitment to stabilizing the supply of Forxiga so that patients taking Forxiga for type 2 diabetes, chronic heart failure, and chronic kidney disease will not experience any inconvenience.
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- Reimb of renal anemia drug in progress upon FDA approval
- by Nho, Byung Chul Mar 29, 2024 05:53am
- The discussions on the insurance reimbursement of tablet-type renal anemia drugs are expected to gain momentum. As Korea’s health authorities were eyeing whether to start pricing negotiations for Mitsubishi Tanabe Pharma’s Vadanem based on the FDA’s approval decision in the U.S. and pricing decision in Europe, the FDA approval is expected to accelerate the drug’s negotiation process in Korea. According to industry sources, Vadanem was approved by the FDA on the 27th and is expected to receive pricing in Europe as early as April. Vadanem already received approval from the Ministry of Food and Drug Safety last year. The same year, the company applied for US approval of the drug for the indication ‘as a treatment for adult patients with chronic kidney disease who are receiving dialysis (peritoneal dialysis, hemodialysis), which the FDA has recently granted approval for. Currently, oral renal anemia drugs that are about to be commercialized in Korea include Vadanem (vadadustat) and JW Pharmaceutical's Enaroy (enarodustat). If the companies find a reasonably weighed average price compared with their alternatives at the drug pricing negotiation stage with the National Health Insurance Service, they may become the first reimbursed oral renal anemia drug option available in Korea. However, it is expected that insurance benefits for non-dialysis patients other than hemolytic anemia, which is the efficacy of the drug, will be limited. What gains attention is whether AstraZeneca's Evrenzo (roxadustat), which was the first drug to be approved in Korea in 2021, will be withdrawn from the market. The failure of Evrenzo’s landing in Korea, which was the first oral renal anemia drug that marked the start of the approvals, is due to the company's decision to reject the domestic pharmacoeconomic evaluation results and the weighted average price of its alternatives based on its headquarters' high pricing policy for orphan drugs. In other words, the company has no plan to launch the drug at a low price in the barren market environment. The reason why innovative new drugs related to renal diseases require expedited listing is to expand patient treatment options and save health insurance finances. According to the National Health Insurance Service data, the number of patients with chronic kidney disease in Korea increased by 36.9% from 206,061 in 2017 to 282,169 in 2021 and surged 82.8% among those in their 80s. The number of hemodialysis patients is also growing exponentially, and healthcare expenditures spent on the 100,000 patients currently approaching KRW 3 trillion. Until now, the existing market for renal anemia drugs has been mainly dominated by erythropoiesis-stimulating agents (ESAs) and has formed a KRW 100 billion market in Korea. The existing injectables mainly consist of 3 substances: epoetin alfa (recombinant human erythropoietin), darbepoetin alfa, and methoxy polyethylene glycol-epoetin beta. The development of oral tablet formulations by companies in Korea and abroad is raising expectations on the introduction of new treatment options in the renal anemia treatment market that is currently dominated by injectables. Enaroy and Vadanem are hypoxia-inducible factor-proly hydroxylase (HIF-PH) inhibitors that work by activating the erythropoietin (EPO), a hormone that promotes red blood cell production, and reducing hepcidin, a hormone that regulates iron metabolism, to improve hemoglobin levels. Both drugs are available in tablet (pill) form, which offers the advantage of improving dosing compared to traditional injections, as well as increasing the cost-effectiveness in patient care.
- Company
- Samsung Bioepis makes 3rd investment in ADCs
- by Son, Hyung-Min Mar 28, 2024 05:52am
- Samsung Group, together with Samsung Bioepis, has made its third investment in companies discovering Antibody-Drug Conjugates (ADCs). Samsung Group plans to actively participate in new drug commercialization through acquiring the original technology as Samsung Biologics expands its CDMO facility for producing ADCs. Samsung Group announced on the 26th that it has invested in BrickBio, a company focused on developing ADCs, through Life Sciences Fund. Life Sciences Fund is a venture investment fund established jointly with Samsung Bioepis, Samsung C&T Corporation, and Samsung Biologics, collectively pooling KRW 170 billion. This is Samsung Group’s third investment in companies developing ADCs, following its investments in Swiss Araris Biotech and Korea’s AimedBio. Samsung Biologics anticipates completing the production facility for ADCs this December. Samsung Group aims to secure ADC CDMO production capacity while acquiring its new drug through investment in shares. Samsung Bioepis focuses on acquiring ADC technology. The US-based company BrickBio, which Samsung Group recently invested in, has the Evolved tRNA Localization (ETRNAL) platform. Through this platform, BrickBio can utilize modified tRNA (transport RNA) to attach artificial amino acids to specific positions on proteins. Notably, BrickBio's linkers are soluble in aqueous solutions like blood, enabling the antibody/payload structure to bind to cancer cells appropriately without additional editing. BrickBio’s current candidate products are BRKB-300, BRKB-400, BRKB-20, BRKB-500. BRKB-300 is a solid tumor ADC that targets B7-H3. It is currently in the process of preparing for an Investigational New Drug (IND) approval. There are no other commercialized products with this mechanism. The rest of the candidate products, like BRKB-400, are either in the preclinical or candidate exploration stages. AimedBio holds the ADC candidate ABM302, which targets FGFR3, a biomarker mainly expressed in bladder cancer. ABM302 is co-developed with China's GeneQuantum Healthcare, combining AimedBio's developed FGFR3 antibody with GeneQuantum's linker-payload technology. AimedBio's ADC technology is characterized by having control of the Antibody-Payload Ratio (DAR). Currently, no ADCs use this mechanism for solid tumor therapy targeting the FGFR3 protein. While FGFR3 is a key protein for solid tumor therapy, no drugs are currently developed using this mechanism as an ADC. In preclinical studies, ABM302 demonstrated pharmacokinetics and safety in nonhuman primates. Samsung Bioepis begins ADC research and development with the Swiss company Araris Biotech. Araris has linker technology capable of conjugating antibodies through a single process. Araris' linker technology enables payload attachment at amino acid (Q295) sites within IgG-Fc. When payloads attach to this site, antibodies maintain nearly identical pharmacokinetic performance. Moreover, the linker payload, connected to the antibody via peptide conjugation, maintains excellent stability in circulation, avoiding damage to healthy tissues. These three characteristics are considered key factors that enable efficient payload delivery and maximum ADC efficiency. Focuses on acquiring ADC technology… Increasing need for developing third-generation ADCs ADC is a novel anticancer drug that connects an antibody, which binds to specific antigens on the surface of cancer cells, with a cytotoxic drug linked by a linker. ADCs take advantage of antibodies' selectivity for their targets and the drug's cytotoxic activity to selectively target cancer cells, thereby increasing therapeutic efficacy while minimizing side effects. Securing target selection and linker technology is essential to developing new ADCs. If the drug-antibody connection is weak, the drug may detach from the antibody before reaching the cancer cells. The companies invested by the Samsung Group are recognized for their success in securing antibody drugs and their linker technologies. While first-generation ADCs such as Roche’s Kadcyla have been limited to breast cancer indications, second-generation ADCs are successfully securing a variety of indications. Enhertu, for example, has shown effectiveness in various solid tumor areas such as breast cancer, gastric cancer, non-small cell lung cancer (NSCLC), and colorectal cancer. Gilead's Trodelvy, which has secured indications for breast cancer, has also shown efficacy in NSCLC, urothelial cancer, and other types. There is a growing interest in developing follow-up ADCs for multiple indications, both domestically and internationally. ADCs approved for use or under development utilize microtubule inhibitors or DNA-damaging agents as payloads to conjugate with immunoglobulin G (IgG) antibodies and pH-dependent or non-cleavable linkers. pH-dependent linkers may cause incomplete systemic cytotoxicity during plasma circulation, while hydrophobic linkers are prone to aggregation, resulting in poor pharmacokinetics and efficacy in the body. Therefore, there is an increasing need for new ADCs with novel mechanisms of action that can maintain a high and consistent drug-antibody ratio, employ cleavable linkers for plasma stability, and demonstrate efficacy even in heterogeneous tumor environments with low target protein expression.
- Company
- HK Inno.N speeds up clinical research on its NSCLC candidate
- by Nho, Byung Chul Mar 28, 2024 05:52am
- On the 27th, HK inno.N announced that it will present the non-clinical trial results of its next-generation allosteric EGFR-tyrosine kinase inhibitor ("EGFR-TKI") candidate through a poster presentation at the American Association for Cancer Research (AACR) Annual Meeting 2024 from April 5 to 10 in the United States. e AACR is one of the world's three most prestigious cancer conferences along with the American Society of Clinical Oncology (ASCO) and the European Society for Medical Oncology (ESMO), and annually attracts a large number of experts from around the world to share their latest cancer research findings. At the conference, HK Inno.N will present the results of its nonclinical study on its ‘allosteric EGFR-TKI drug’ that targets patients with the L858R gene mutation in non-small cell lung cancer. HK Inno.N is studying the use of IN-119873, a fourth-generation targeted anticancer drug for patients with L858R mutations who have shown resistance to existing first-line treatments for NSCLC. Unlike existing therapies that target the adenosine triphosphate (ATP) binding site, which is the energy source of cancer cells, HK Inno.N's IN-119873 targets the allosteric (one of the protein sites) binding site of the epidermal growth factor receptor (EGFR). IN-119873 is expected to show superior efficacy in EGFR mutations caused by existing first-, second-, and third-generation EGFR-TKI drugs, and be synergistic in combination with third-generation EGFR-TKIs. The interest in next-generation allosteric EGFR-TKIs has been rising with a major global pharmaceutical company recently acquiring a third-party candidate with the same mechanism of action for approximately USD 540 million (KRW 720 billion). According to global market prospects, the market for NSCLC drugs has reached KRW 30 trillion by 2022. Of this, the market for drugs that treat EGFR mutated NSCLC accounts for around KRW 5 trillion, and osimertinib, a third-generation EGFR-TKI drug, accounts for more than half of this market. Bong-Tae Kim, head of HK inno.N's New Drug Development Division, said, "We plan to present our EGFR-TKI research results to domestic and international companies and experts at AACR and explore potential partnership opportunities. Our goal is to complete the nonclinical study of IN-119873 and file an application to initiate Phase I IND within the year." HK Inno. N introduced IN-119873, a next-generation allosteric EGFR-TKI candidate, after bringing in the candidate substance from the Korea research Institute of Chemical Technology and being nominated as a project to be supported by the National Drug Development Program in August last year. In September last year, the company signed a collaborative research agreement with Dong-A ST on studying a ‘next-generation EGFR inhibitor,' to develop an existing allosteric EGFR inhibitor into an EGFR inhibitor degrader, and have continued to research and develop targeted anti-cancer drugs for non-small cell lung cancer.
- Company
- New breast cancer drug ‘Truqap’ soon to land in KOR
- by Eo, Yun-Ho Mar 28, 2024 05:52am
- New AKT inhibitor for breast cancer ‘Truqap.’ The AKT inhibitor 'Truqap' is likely to enter the Korean market. According to industry sources, AstraZeneca Korea has submitted an application for Truqap (capivasertib), which is used in combination with 'Faslodex (fulvestrant),' approval to the Ministry of Food and Drug Safety (MFDS), and is under review. The approval is expected to be granted within this year. Truqap is indicated for ‘the second-line therapy or more of patients with HR-positive or HER-negative locally advanced or metastatic breast cancer who have one or more 'PIK3CA/AKT1/PTEN mutations.’ In June of last year, Truqap received a Priority Review designation from the U.S. Food and Drug Administration (FDA). Subsequently, Truqap was approved in November of the same year. Tumors with resistance with endocrine therapies often harbor alterations in AKT signaling through PI3K-AKT-PTEN pathway. By blocking this signaling pathway, capivasertib exerts anti-growth effects and shows synergic effects with endocrine therapies. In the CAPItello-291 study, which was the basis for the U.S. approval, capivasertib in combination with fulvestrant extended progression-free survival (PFS) by more than twice compared to fulvestrant alone. The study enrolled 708 patients with alterations in the AKT pathway (41%), no alterations in the AKT pathway, and prior CDK4/6 inhibitor therapy (69%). The median progression-free survival (PFS) of combination therapy was 7.3 months, showing approximately 50% reduction in the disease progression or risk of death compared to 3.1 months in the comparator group. Truqap also prepares for the approval process in the European Union, China, and Japan.
