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- 2026-05-04 18:09:05
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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is whether AstraZeneca's Evrenzo (roxadustat), which was the first drug to be approved in Korea in 2021, will be withdrawn from the market.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.
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- 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.
- Company
- AI-based liquid biopsy companies deliver tangible results
- by Son, Hyung-Min Mar 28, 2024 05:52am
- Domestic companies have started to deliver tangible results with their liquid biopsy technology. The early cancer diagnosis accuracy of GC Genome’s ai-CANCERCH and IMBdx’s CancerFind were found to be over 80%. EDGC's (Eone-Diagnomics Genome Center) test showed an 80% sensitivity in diagnosing colorectal cancer. Liquid biopsy detects diseases from blood, body fluids, or urine, enabling faster and more convenient testing than standard biopsy, which involves removing the tumor directly. Liquid biopsy can be conducted even without the patient’s tissue. Extracting tissue from cancer patients becomes increasingly difficult after the development of chemoresistance. When a biopsy is first performed, tissue extraction is usually possible in more than 90% of cases, but that probability gradually decreases for patients who develop resistance to anticancer drugs. For this reason, liquid biopsy has been considered as a replacement for regular biopsy, but is only applicable to certain cancers and is not 100% accurate, thereby requiring further testing. However, it can be useful for early diagnosis and prediction of cancer, and major liquid biopsy diagnostic companies have been targeting the early cancer diagnosis market. Korean company secures a platform that can diagnose early solid cancer through blood According to data recently released by GC Genome on the 28th, ai-CANCERCH’s accuracy in diagnosing Stage I cancer reached 81.1%. ai-CANCERCH is an AI-based liquid biopsy diagnostic platform developed by GC Genome. The program was released in Korea in September last year. ai-CANCERCH’s uses AI algorithms to extract circulating tumor DNA (ctDNA) from cell-free DNA (cfDNA) floating in blood vessels and use next-generation sequencing (NGS) to identify the presence of tumors at an early stage. Cancer cell-derived cfDNA is DNA released from the cell into the blood and owns the characteristic of autologous cells. Ai-CANCERCH’s testing accuracy was verified through analysis of a total of 5,000 samples, involving more than 1,300 cancer patients and more than 3,700 general people. Ai-CANCERCH can diagnose the presence six cancers - lung, liver, colorectal, pancreatic, esophageal, and ovarian cancers. Earlier this month, GC Genome signed contracts for diagnostic genome analysis services with 6 companies – 1 in Jordan, 3 in Saudi Arabia, 1 in Oman, and 1 in Pakistan. In addition to GC Genome, IMBdx and EDGC are also developing AI-based liquid biopsy tests. IMBdx develops precision cancer diagnostics technology and was founded by Dr. Tae-You Kim, Professor of Medical Oncology at Seoul National University Hospital. The company is set to go public on KOSDAQ next month. IMBdx’s early cancer diagnosis platform is called CancerFind. It can diagnose 8 types of cancers including colorectal, liver, lung, prostate, ovarian, stomach, and pancreatic cancers, through a single blood draw. CancerFind analyzes the genetic and epigenetic signatures of ctDNA to detect cancer and provide information about the cancer site. It is a quick and easy cancer screening tool that can be used not only by those in need of biopsy, but also by general patients who have difficulty receiving imaging and endoscopy tests. To date, the company's cancer diagnostic test showed a 86% sensitivity and can localize cancer with 83% accuracy. EDGC has been demonstrating its liquid biopsy technology in early cancer screening for colorectal and lung cancer. EDGC uses its liquid biopsy-based platform OncoCatch to extract ctDNA from cell-free cfDNA floating in the blood. It then applies an AI algorithm to measure epigenetic changes associated with cancer development, enabling cancer diagnosis at the earliest stage. EDGC evaluated its cancer prediction model by type on 191 cancer patients and 126 members of the general public and found that the sensitivity was 78.1% for colorectal cancer and 66.3% for lung cancer. EDGC plans to first target the North American market with its testing tool. In August last year, the company joined the U.S. Cancer Moonshot project aimed at conquering cancer. Cancer Moonshot is a cancer conquest project promoted by the Biden administration that aims to reduce the mortality rate of cancer patients by over 50% within the next 25 years by accelerating the development of cancer R&D. EDGC also started exporting its liquid biopsy technology after acquiring the US company GDxLab last year.
- Company
- Dt&CRO signs MOU with U.S. company Radyus Research
- by Nho, Byung Chul Mar 27, 2024 06:04am
- On the 25th, Dt&CRO announced that it had signed a memorandum of understanding (MOU) with Radyus Research, a U.S. clinical consulting organization. The MOU is expected to add momentum to the company’s full-cycle consulting service that is provided to domestic pharma and biotech companies that apply for Investigational New Drug (IND) or file a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMA). As a GLP-certified organization, Dt&CRO is a full-service CRO capable of conducting non-clinical trials, Phase I-III clinical trials, post-marketing surveillance (PMS), observational studies (OS), as well as pharmacovigilance (PV) studies in various fields including pharmaceuticals, medical devices, and health function foods. Its another advantage is that the company works closely with its central laboratory HuScience, and SafeSoft, which develops and provides e-clinical solutions. Radyus Research is a consulting service provider for INDs. The company has experts with experience in various fields including pharmaceutical, biotech, academia, hospitals, and CROs. Building on its experience of receiving more than 100 IND approvals and 20 NDA approvals since its inception, the company has partners around the world, including those in the U.S., Europe, and Asia, and has signed an agreement with Dt&CRO to make the first step into Korea’s industry. Under the agreement, the two companies will provide a 3-step customized service for efficient application and approval of non-clinical and clinical trials by the FDA and EMA. To this end, the 2 companies will combine Dt&CRO’s Good Laboratory Practice (GLP) and Radyus Research’s US and European certification consulting expertise. In particular, Dt&CRO will be responsible for conducting testing and establishing consulting plans in accordance with the GLP standards. The two companies will meet at CPHI North America in May to discuss ongoing business, and then hold a joint seminar in Korea in July. Chae-Kyu Park, CEO of Dt&CRO, said, "In order for domestic companies to obtain IND/NDA approval from the FDA/EMA, they had to inconveniently receive consulting for non-clinical trials and IND/NDA approvals separately at different companies. For this reason, the companies had to endure a lot of time and money in each stage of company selection, testing, and consulting. Through the MOU, we can now provide quick and accurate services to help companies enter the overseas pharmaceutical market at a reasonable cost.”
- Company
- No news on Phesgo's reimb progress for 7 months
- by Eo, Yun-Ho Mar 27, 2024 06:04am
- The insurance reimbursement process for Phesgo, a drug that was expected to benefit from the preferential drug pricing system, is making little progress. No news has been heard on its progress for 7 months. Roche Korea’s Perjeta (pertuzumab+ trastuzumab), a subcutaneous injectable combination of the company’s Perjeta and Herceptin, passed the Health Insurance Review and Assessment Service's Cancer Disease Deliberation Committee review in August last year. Since then, Roche has been negotiating with the National Health Insurance Service on Perjeta’s supply and quality control terms after the application was reported to the Drug Reimbursement Evaluation Committee. However, there has been no news of a settlement or breakdown of the negotiations to date. Phesgo was recognized as the first biobetter anticancer drug for its innovativeness in improving patient convenience and reducing treatment time by converting the intravenous Herceptin and Perjeta injections into a fixed-dose subcutaneous injection. If a patient with metastatic HER2-positive breast cancer who was receiving maintenance therapy every 3 weeks with intravenous Herceptin-Perjeta switches to Phesgo SC, his or her total dosing and monitoring time is reduced by 90% from 270 minutes (90 +180 minutes) to 20 minutes (5 +15 minutes). In addition, Phesgo is administered subcutaneously to the thigh, rather than through a vein, reducing the risk of blood vessel and nerve damage from repeated intravenous injections. These benefits of Phesgo can serve as an advantage amid the current healthcare disruptions present in Korea. However, due to delays in the approval process, which could have been completed as early as the end of last year, have rendered the drug a “pie in the sky” for the patients. In the case of Nexviazyme (avalglucosidase alfa), which was the first biobetter drug to receive preferential treatment, the process took five months to complete. Therefore, it remains to be seen how much longer the tug-of-war between the government and Roche, which began last year, will last. The NCCN guidelines state that Phesgo can replace Perjeta-Herceptin, and in the UK, 90% of patients treated with Herceptin and Perjeta switched to Phesgo in the first year of Phesgo's launch. Therefore, a significant number of patients treated with Herceptin-Perjeta are likely to switch to Phesgo upon its approval in Korea. Meanwhile, in 2016, the government announced a plan to provide preferential drug pricing for biobetters that show an improvement over approved biosimilars and biologics that have contributed to the improvement of healthcare in Korea. Given the difficulty of developing biobetters compared to synthetic drugs, the price of biobetters was set at 100% to 120% of the price of the target product (original, etc.), and Nexviazyme became the first drug to benefit from the measure.
- Company
- Adtralza reimb drives biologics competition in atopy market
- by Eo, Yun-Ho Mar 26, 2024 06:30am
- (Photos from the left) Sanofi’s Dupixent and LEO Pharma’s Adtralza. Biopharmaceuticals face competition in the atopic dermatitis sector. According to industry sources, LEO Pharma’s Adtralza (tralokinumab), a treatment for atopic dermatitis with an underlying mechanism of neutralizing interleukin-13 (IL-13), is anticipated to launch with reimbursement starting in May. Adtralza is the second biologic approved for atopic dermatitis, following Sanofi-aventis Korea’s 'Dupixent (dupilumab).' Adtralza was approved in Korea last August and passed the review by the Drug Reimbursement Evaluation Committee (DREC) of the Health Insurance Review and Assessment Service (HIRA). The company recently completed price negotiations with the National Health Insurance Service (NHIS). It can expect to be listed as early as April, but the company is preparing for an official launch in May. Adtralza is indicated for adults (18 years of age and over) and children (12-17 years of age) with moderate to severe atopic dermatitis that is not adequately managed by topical treatments or for whom topical treatments are not advised. Adtralza’s recommended initial dose is 600 mg (given as four injections of 150 mg) followed by 300 mg (given as two injections of 150 mg) every two weeks. Adtralza provides a convenient dosing option for patients with moderate to severe atopic dermatitis. At the doctor’s discretion, patients who achieve clear or almost clear skin after 16 weeks of treatment may consider dosing every fourth week. This drug is a biopharmaceutical that specifically targets IL-13. While Sanofi-aventis Korea’s Dupixent (dupilumab) targets both IL-4 and IL-13, it is difficult to compare the mechanism of actions of the two drugs directly. To what extent Adtralza's entry will impact the atopic dermatitis market competition remains to be watched. Dupixent is steadily expanding its presence in the Korean market. It renewed the Risk Sharing Agreement (RSA) contract in February of last year. Dupixent secured an initial four-year RSA contract from January 2020 to December 2023. The type of contract was a refund model, a total expenditure cap model, and an initial treatment cost refund model. Initially, Dupixent was covered by reimbursement for treating atopic dermatitis in adults but later expanded to include children and adolescents aged six years and above. Recently, it is being discussed for the reimbursement expansion for treating toddlers aged six months to five years with severe atopic dermatitis. Additionally, it is considered for the reimbursement expansion for treating adult asthma, in addition to atopic dermatitis. The market for atopic dermatitis comes alive as orally administered JAK inhibitors join. JAK inhibitors that have indications of atopic dermatitis are Lilly Korea’s 'Olumiant (baricitinib),' Korea abbvie’s 'Rinvoq (upadacitinib),' and Pfizer Korea’s ‘Cibinqo (abrocitinib).’ These drugs are covered by insurance reimbursement.
- Company
- Sam Chun Dang Pharm introduces Eylea biosimilar to Europe
- by Nho, Byung Chul Mar 26, 2024 06:30am
- Sam Chun Dang Pharm. Sam Chun Dang Pharm announced on the 25th an exclusive distribution agreement for the Eylea biosimilar with nine Western European countries (UK, Belgium, Netherlands, Norway, Portugal, Sweden, Greece, Ireland, and Finland). Under the agreement, Sam Chun Dang Pharm will receive 55% of the partnering company’s net sales, further strengthening its presence in the European market. Sam Chun Dang Pharm has established a sales network in the UK, Germany, Spain, and Italy, and the current agreement has established a stepping stone for entering the UK market, which is the biggest market in Europe: “Sam Chun Dang Pharm was able to sign the agreement on the most favorable terms as we received 55% of the sales. This was possible because Eylea PFS (Pre-filled Syringe) dominates 90% of the total sales in the European market. Additionally, Sam Chun Dang Pharm took advantage of being the first-mover in the market by applying for EMA for the first time as a Eylea biosimilar PFS in Europe,” an official from Sam Chun Dang Pharm stated. And explained, “The product has price competitiveness, and it does not pose a potential infringement of original patent.” The fact that Sam Chun Dang Pharm is the only biosimilar developer to have signed contracts with advanced countries such as Europe, Canada, and Japan, besides companies with direct sales systems, proves its presence in the industry. In November last year, Sam Chun Dang Pharm achieved contract fees and milestones amounting to 50 million euros (approximately KRW 70 billion), including contracts with five European countries. They achieved the targeted contract fees and milestones in 14 countries, excluding France. According to the company's explanation, the amount is expected to increase as more country contracts are added. The French government passed a bill to promote the use of biosimilars, which is postulating the expansion of the French market. Sam Chun Dang Pharm is currently developing a new marketing strategy and will soon enter the French market with conditions tailored to this specific environment. The company is also in the final stages of contract negotiations with Eastern European countries. Including this recent contract, Sam Chun Dang Pharm has secured KRW 140 billion in contract payments and milestones, with expected sales exceeding KRW 6 trillion. The company plans to establish a dominant presence in major advanced countries' markets and plans to further expand its influence in the global healthcare sector. “In addition to closely monitoring opportunities to enter France, the last remaining country in Europe, and Eastern Europe, we are closely monitoring the trends in patent disputes with local partners in the United States, the most critical market in North America. We are currently negotiating and are establishing early sales strategies through patent strategies that reflect these trends,” a company official explained. “After finalizing this contract, “In addition to closely monitoring opportunities to enter France, the last remaining country in Europe, and Eastern Europe, we are closely monitoring the trends in patent disputes with local partners in the United States, the most critical market in North America. We are currently negotiating and are establishing early sales strategies through patent strategies that reflect these trends,” a company official explained. “After finalizing this contract, Sam Chun Dang Pharm will secure its presence in the European and North American markets, representing 80% of the global market. This achievement will be a significant stepping stone for Sam Chun Dang Pharm to become a leader in the global biosimilar market.” will secure its presence in the European and North American markets, representing 80% of the global market. This achievement will be a significant stepping stone for Sam Chun Dang Pharm to become a leader in the global biosimilar market.”
- Company
- Takeda’s colorectal cancer drug 'Fruzaqla' nears KOR entry
- by Eo, Yun-Ho Mar 26, 2024 06:30am
- New colorectal cancer drug New colorectal cancer drug 'Fruzaqla' is likely to receive approval for commercialization in South Korea. According to industry sources on the 11th, Takeda Pharmaceuticals Korea’s Fruzaqla (fruquintinib), designated as Global Innovative products on Fast Track (GIFT) by the Ministry of Food and Drug Safety (MFDS), is under review for approval. GIFT-designated pharmaceuticals are provided various supports for rapid commercialization, including ▲supports for preparing requirements for regulatory approval ▲rolling review process is applied, which enables regulatory review on prepared documents first ▲close communication between the regulatory reviewer and the developing company, such as briefing of an item and complementary support sessions ▲regulatory supports, including RA consulting. As a GIFT-designated product, Fruzaqla is expected to receive faster product approval. Fruzaqla received the Orphan Drug Designation last month in South Korea. The FDA designated Fruzaqla for priority review in May last year and approved the drug in November of the same year. Fruzaqla is indicated for ‘the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with flouropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, or who have been previously treated or cannot be treated with an anti-VEGF treatment, an anti-EFGR treatment (if RAS wild-type), and at least one of trifluridine plus tipiracil or regorafenib treatment.’ Fruzaqla is a VEGFR-1, -2, -3 receptors inhibitor that Takeda Pharmaceutical acquired the rights to the drug from Hong Kong Hutchmed. The efficacy of Fruzaqla was evaluated based on the FRESCO clinical trial conducted in China and published in JAMA and the global FRESCO-2 clinical trial published in LANSET. These clinical trials compared the combination therapy of Fruzaqla plus best supportive care (BSC) with placebo combination therapy in patients with previously treated metastatic CRC (mCRC). The FRESCO and FRESCO-2 clinical trials achieved primary endpoints and crucial secondary endpoints, demonstrating consistent effectiveness in 734 patients who received Fruzaqla treatment. In FRESCRO-2 clinical trial, the fruquintinib-treatment group yielded a median overall survival (OS) of 7.4 months, versus 4.8 months for the placebo group. In FRESCO clinical trial, the fruquintinib-treatment group yielded a median OS of 9.3 months, versus 6.6 months in the placebo group. The GIFT program designates products that fall into one of the following standards: ▲a medicinal product intended for the treatment of serious diseases, such as life-threatening cancers ▲a medicinal product intended for the prevention or treatment of infectious diseases with a serious threat to public health, such as an infectious disease outbreak caused by bioterrorism or pandemic ▲a new medicinal product developed by an innovative pharmaceutical company designated and notified by the Ministry of Health and Welfare ▲a combination of a medical device and a medicinal product designated for expedited review.
