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- 2026-05-13 22:00:59
- Policy
- Will Gilead reclaim its throne in the HCV drug market?
- by Lee, Tak-Sun Oct 24, 2022 06:08am
- Fierce competition is being expected in the hepatitis C (HCV) treatment market with the launch of Gilead’s new treatment which is priced at a lower level than the current market leader. With the new product, Gilead is aspiring to reclaim the former glory that it had enjoyed dominating the market with Sovaldi. According to industry sources on the 21st, Gilead Science Korea’s HCV treatment ‘Epclusa Tab (velpatasvir+sofosbuvir) and ‘Vosevi Tab (velpatasvir+sofosbuvir+voxilarprevir)’ will receive health insurance reimbursement from the 1st of next month. The insurance price ceiling for Epclusa and Vosevi was set at KRW 117,030 and KRW 120,836, respectively. The current market leader in the HCV treatment market is Abbvie Korea’s Mavyret (glecaprevir+pibrentasvir). Mavyret can be used in all Chronic HCV patients, in all HCV genotypes 1, 2, 3, 4, 5, or 6. Also, its treatment period is shorter than its competitors, with an 8-week regimen. On the other hand, Gilead’s Harvoni tab cannot be used in patients with genotype 3, and Sovaldi is unable for use in patients with genotype 5 or 6. Also, their treatment period is 12 weeks, which is 4 weeks longer than Mavyret. Such limitations have brought marked differences in sales of the respective drugs. Based on IQVIA data, Mavyret recorded KRW 46.6 billion, and Harvoni KRW 11.7 billion, Sovaldi KRW 0.2 billion in sales last year. Comparison of major hepatitis C treatments Faced with the need to replace Mavyret, Gilead released Epclusa and Vosevi. Both may be used in all HCV genotypes 1-6. However, to use Vosevi, the patient needs to have prior HCV treatment experience. Although both of the treatments have a longer treatment period than Mavryet, with a 12-week treatment regimen, it can be overcome by the price difference. If we calculate the treatment using the price ceiling set this time, Epclusa will cost KRW 9,835,000 and Vosevi KRW 10,152,224 won in patients without cirrhosis. This is KRW10,922,352 cheaper than Mavyret, and also cheaper than the previous Gilead products. Havoni costs KRW1,092,924 and Sovaldi KRW 10,599,624. The low price of Vosevi and Epclusa has been somewhat expected as the company accepted the weighted average price of alternative drugs proposed by HIRA in July. As their price is set at a lower level than their alternatives, the two drugs passed the HIRA DREC review in July and were listed for reimbursement in only 4 months. This is interpreted as Gilead’s determination to overcome AbbVie and restore the former glory it had with Sovaldi, the first oral drug to cure hepatitis C that had switched the paradigm. Given that Gilead and AbbVie's products can treat all genotypes, the competition in HCV is expected to narrow into a battle between Mavyret, which has a short treatment period, or the cheaper option, Epclusa.
- Company
- Lucentis biosimilar of Chong Kun Dang gets domestic approval
- by Chon, Seung-Hyun Oct 24, 2022 06:08am
- Chong Kun Dang succeeded in commercializing its second biosimilar. Chong Kun Dang announced on the 20th that it has received approval from the Ministry of Food and Drug Safety for domestic items of the "Lucentis" biosimilar. The indication for "treatment of neovascular (habitual) age-related macular degeneration" has been approved. Lucentis, sold by Roche and Novartis, is a drug used to treat eye diseases such as macular degeneration diabetes, and macular edema. Lucentis is a large product with global sales of 4.4 trillion won last year. Chong Kun Dang proved that the therapeutic effects of CKD-701 and Lucentis were equal through phase 3 clinical trials of 312 neovascular age-related macular degeneration patients at 25 hospitals, including Seoul National University Hospital, from September 2018 to March last year. According to IQVIA, a pharmaceutical research institute, Lucentis recorded 35.1 billion won in sales in Korea last year. Chong Kun Dang is the second Korean company to succeed in commercializing Lucentis biosimilars after Samsung Bioepis. Samsung Bioepis received an item license from Lucentis biosimilar Amelivu in May. Chong Kun Dang said, "We expect CKD-701 to provide patients with various treatment drug choices and expand treatment opportunities." Chong Kun Dang said, "It will be released after going through the health insurance registration process." As a result, Chong Kun Dang produced its own second biosimilar. Chong Kun Dang received domestic permission from biosimilar Nesbell for the anemia treatment NESP in November 2018. After securing differentiated raw material manufacturing technology in 2008, Chong Kun Dang established a biopharmaceutical production infrastructure in 2012 and developed Nesbell.
- Policy
- Severe AD treatments unlikely to be reimb this year
- by Lee, Tak-Sun Oct 21, 2022 05:48am
- It seems that reimbursement extensions for severe atopic dermatitis treatments like Dupxient to benefit pediatric and adolescent patients will only be possible after next year. This is because the current reimbursement review process in progress would render reimbursements within the year difficult. This news was revealed in the written QA response released by the Health Insurance Review and Assessment Service on the 13th after the NA audit. HIRA disclosed the reimbursement review progress of the treatments in response to the claim made by Rep. Young-Seok Suh of the Democratic Party of Korea on how the government should hasten reimbursement of severe atopic dermatitis treatment for pediatric and adolescent patients. In the case of Dupixent pre-filled inj 300mg, its reimbursement extension to pediatric and adolescent patients had been reviewed in January and April last year, respectively, and reported to the Ministry of Health and Welfare. In September, HIRA explained that it had requested Dupxient’s cost-effectiveness data to MOHW and that the agenda is under review. However, even though the drug is under review, it will be difficult for Dupxient to pass the Drug Reimbursement Evaluation Committee review, complete drug pricing negotiations, and be listed for reimbursement within the year. HIRA’s Pharmacoeconomic Evaluation Subcommittee’s deliberations are set to be held after December this year, and deliberations by the Drug Reimbursement Evaluation Committee will be conducted after January next year. The Dupixent pre-filled inj 200mg, which is seeking a new listing, will also be reviewed for reimbursement together with the higher-strength formulation. Reimbursement extensions for the Rinvoq SR tab also face a similar situation. Its company applied for reimbursement expansions to adolescents on September 30. HIRA said an expert advisory meeting for the drug is scheduled after December. Among the AD treatments, Pfizer’s Civinqo tab is likely to be listed the fastest. The drug applied for reimbursement listing in April, passed the Pharmacoeconomic Evaluation Subcommittee deliberations in August and is set to receive DREC deliberations after December. Dupixent pre-filled inj can be used for the treatment of adult, adolescent, and pediatric patients aged 6 years or older with moderate-to-severe atopic dermatitis. RInvoq SR and Civinqo tab are allowed for use to treat adult and adolescent patients aged 12 years or older with moderate-to-severe atopic dermatitis. However, reimbursement is only allowed for adult patients, and even this is only applied to Dupxient and Rinvoq. In a press release on the 18th, Rep. Young-Seok Suh of the Democratic Party of Korea requested expedited reimbursement of Dupisent, explaining that “Dupxient is only applied reimbursement for adult patients aged 18 years or older under HIRA’s Dupixent insurance recognition standards. Parents of young children with atopic dermatitis long for its prompt reimbursement in pediatric and adolescent patients."
- Policy
- Epclusa, a hepatitis C tx, costs 117,030 won
- by Kim, Jung-Ju Oct 21, 2022 05:48am
- Gilead Sciences Korea's Sofosbuvir/Velpatasvir-based chronic hepatitis C drugs Epclusa and Vosevi are expected to be listed on the 1st of next month at insurance drug prices of 117,000 won and 128,800 won, respectively. The government and insurance authorities expect to reduce health insurance finances as prices are agreed to be cheaper than alternative drugs during drug price negotiations. According to industries on the 20th, the Ministry of Health and Welfare is planning and proceeding with the "Amendment to the Pharmaceutical Benefits List and Salary Limit Table" on the 1st of next month based on the results of the NHIS' drug price negotiations with Gilead Science Korea. ◆Epclusa = This new drug is a combination of the HCV NS5B polymerase inhibitor Sofosbuvir and the NS5A inhibitor Velpatasvir, which is a pan-genetic drug that can be used in all genotypes. The treatment of patients with untargeted cirrhosis is also characterized by its ability to be used regardless of genotype Alternative drugs vary. Adult patients with no cirrhosis or targeted cirrhosis may use Sovaldi + Ribavirin and Ledipasvir + Sovaldi, Zepatier, Maviret/Pibrentasvir'. When used in adult patients with untargeted cirrhosis, the substitute is the combined administration of Sovaldi + Ribavirin and Harvoni + Ribavirin. For pediatric patients, it is Harvoni/Sovaldi, Maviret (Glecaprevir)/Pibrentasvir. The drug, which obtained an item license from the Ministry of Food and Drug Safety in February of this year, applied for insurance registration with the HIRA in the same month. In July, the HIRA conducted deliberation by the Drug Benefit Evaluation Committee. At the time, the committee expected that the company would accept the weighted average price of 130,019 won per party, which is a cost-effective and lower cost than alternative drugs, so there would be no additional financial need and reduction. It is listed in the United States, Japan, France, Germany, Italy, Switzerland, and the United Kingdom. After the drug passed, the company negotiated drug prices with the NHIS from August until recently and reached a final agreement with the drug price at 110,730 won. ◆Vosevi= This drug is a three-drug complex in which Voxilaprevir is added to Epclusa, and the alternative drug treatment is a complex administration of "Maviret (Glecaprevir/Pibrentasvir). The drug, which obtained an item license from the Ministry of Food and Drug Safety in March of this year, was applied for insurance registration to the HIRA in the same month. The HIRA held a committee meeting in July and presented it with Epclusa for deliberation. At the time, the committee decided that it would accept the weighted average price of alternative drugs, 190,542 per tablet, which is cost-effective, and that there would be no additional financial need due to the lower cost than alternative drugs. Among the A7 countries, it is listed in five countries: the United States, France, Germany, Italy, and the United Kingdom. Since August until recently, the company has negotiated drug prices with the NHIS and finally agreed to 120,836 won per tablet.
- Company
- Tumor-agnostic Vitrakvi lands in Big 5 tertiary hospitals
- by Eo, Yun-Ho Oct 21, 2022 05:47am
- The tumor-agnostic drug ‘Vitrakvi’ has landed in the Big 5 tertiary hospitals in Korea. According to industry sources, Bayer Korea’s neurotrophic tyrosine receptor kinase targeted anticancer drug Vitrakvi (larotrectinib) has passed the drug committees of major hospitals in Korea, including general hospitals like the Samsung Medical Center, Seoul National University Hospital, Seoul St.Mary’s Hospital, Asan Medical Center, and Sinchon Severance Hospital and major medical institutions such as Gangnam Severance Hospital, National Cancer Center, and Seoul National University Bundang Hospital. The drug is seemingly settling quickly in the prescription market after it was listed for reimbursement in April. Vitrakvi, which received marketing approval in Korea in May last year, underwent the reimbursement listing process through the pharmacoeconomic evaluation exemption track and passed HIRA’s Drug Reimbursement Evaluation Committee review in November. Its competitor which has the same mechanism of action, Roche’s ‘Rozyltrek’ is also undergoing pricing negotiations with the NHIS. Vitrakvi is indicated for use in adult and pediatric patients with solid cancer who have progressed after using conventional treatment options or have no suitable treatment options available that have NTRK gene fusions without a known acquired resistance mutation, that are either metastatic or where surgical resection is likely to result in severe morbidity. In other words, it may be used in virtually most cancer types with an identified NTRK gene. Vitrakvi’s approval was based on data from a Phase I trial on adults 18 years and older, the Phase II NAVIGATE study on pediatric and adult patients over the age of 12, and the Phase I/II SCOUT study on pediatric patients aged 1 month to 21 years that includes those with primary CNS tumor. According to an efficacy review that was conducted on 55 patients with identified NTRK fusion in the 3 studies above, Vitrakvi’s overall response rate (ORR) was 75% and partial response 53% in various cancer types (including soft tissue sarcoma, infantile fibrosarcoma, salivary gland tumors, thyroid cancer, lung cancer, melanoma, colon cancer, gastrointestinal stromal tumor, cholangiocarcinoma, appendiceal carcinoma, breast cancer, and pancreatic cancer) Vitrakvi showed an effect not only in adults but also in pediatric patients. Twenty-four patients aged 1 year or less participated in the studies above, and the drug showed the same efficacy in these patients as in adult patients. As a result, Vitrakvi was approved for use in both pediatric and adult patients.
- Policy
- The head of the MFDS actively agrees with the opinion
- by Lee, Hye-Kyung Oct 21, 2022 05:47am
- Oh Yu-kyung, head of the Ministry of Food and Drug Safety, expressed her intention to actively agree to the introduction of active ingredients. Health and Welfare Minister Cho Kyu-hong avoided answering, saying that he would discuss various measures with the Ministry of Food and Drug Safety to ensure a smooth supply and demand of medicines in the era of a special crisis for infectious diseases. Seo Young-seok, a member of the Democratic Party of Korea, asked for the opinions of the Minister of Health and Welfare and the Minister of Food and Drug Safety on the introduction of active ingredient prescriptions due to the spread of COVID-19 infectious diseases. "With the spread of COVID-19, the national proposal of the Anti-Corruption and Civil Rights Commission included the prescription of ingredients as an excellent agenda," Rep. Seo said. "There was a controversy over the prescription of ingredients in order to reduce health insurance finances and drug costs." Representative Seo said, "The prescription of active ingredient should be discussed as public interest is high, not by a specific group," and stressed, "Since it is a replacement for drugs recognized by the minister, not only preparation of the same ingredient but also prescription of ingredients should be established so that they can be used systematically in the event of a national crisis."
- Company
- Celltrion develops anticancer drugs using ADC platform
- by Oct 21, 2022 05:47am
- Celltrion announced on the 17th that it has signed a contract with domestic bio company Pinotbio to introduce options for implementing ADC Linker-Payload platform technology. With this contract, Celltrion paid advance payments and secured the right to utilize Pinotbio's ADC Linker-PINOT-ADC for up to 15 targets. Celltrion plans to develop ADC anticancer drugs targeting solid cancer by applying PINOT-ADC technology to pipeline candidate materials under development. For a total of 15 target options secured this time, Celltrion can use the technology for one target for each option event, and advance payments, milestones, and royalties for each option event are set separately. ADC Linker-PBD technology is a technology that combines payloads with excellent therapeutic effects with antibodies that react only to specific antigens so that drugs can selectively act on cells expressing antigens. The maximum therapeutic effect can be expected with the minimum drug administration, and the drug can be selectively delivered to the target cell. Celltrion has secured anticancer drugs such as blood cancer treatment Truxima, breast and gastric cancer treatment Herzuma, metastatic direct bowel cancer, non-small cell lung cancer, and ovarian cancer treatment Begzelma. The contract is expected to enable the development of more diverse anticancer drugs by securing options for implementing ADC platform technology. Celltrion signed a contract with Pinotbio to introduce platform technology implementation options, as well as a stake investment and joint research contract. The two companies decided to focus their development capabilities as much as possible to achieve the joint goal of developing ADC treatments while establishing a long-term partnership through equity investment and joint research contracts. An official from Celltrion said, "The introduction of Linker-Payload platform technology has added momentum to the development of ADC anticancer drugs as a future growth engine project. We will actively expand new growth engines through continuous cooperation with promising biotech such as Pinotbio."
- Policy
- Xtandi’s use expanded... reimbursement standard changed
- by Lee, Tak-Sun Oct 20, 2022 06:02am
- The scope of use for the prostate cancer treatment Xtandi soft capsule (enzalutamide, Astellas Korea) will be expanded. Although the drug was applied reimbursement only when other drugs that suppress androgen production cannot be used, reimbursement will be applied regardless of such status starting next month. On the 18th, the Health Insurance Review and Assessment service prepared an amendment to the anticancer drug reimbursement standards that contained the changes above and started reviewing industry opinion. Under the proposed amendment, the reimbursement condition, ‘when other drugs that suppress androgen production cannot be used,' will be deleted from the standards for Xtandi’s reimbursed use in patients with metastatic castration-resistant prostate cancer who have failed docetaxel-based or other chemotherapies. On this, HIRA explained, “The condition had been set during RSA reevaluations, and the relevant standards had been revised since then. As the clinical efficacy of the indication remains the same since deliberations, we deemed it medically justifiable to delete the restrictions without changing the drug’s clinical efficacy in the indication.” Once the opinion inquiry is complete, the amended reimbursement standard will be effective from the first of next month. The reimbursement expansion that applied this time has passed HIRA’s Cancer Disease Deliberation Committee in February this year. Xtandi is a blockbuster anticancer drug that recorded sales of KRW 27.4 billion last year and is an androgen receptor inhibitor that targets the androgen signaling pathway that acts on prostate cancer cells.
- Opinion
- [Reporter’s View] LG Chem’s global two-track strategy
- by Oct 20, 2022 06:02am
- LG Chem announced the acquisition of a US biotech firm on the 18th. LG Chem will invest KRW 800 billion to acquire a 100% stake in AVEO Pharmaceuticals. This is the third-largest in the history of M&As made by domestic pharmaceutical companies. It is also the largest single-company investment along with SK's acquisition of Ampac. AVEO Pharmaceuticals is a 20-year-old biotech specializing in anticancer drugs. The company developed a vascular endothelial growth factor (VEGF) inhibitor and received FDA approval. Although its new drug, ‘Fotivda (tivozanib)’ is not a first-in-class drug, therefore not the first drug with that mechanism of action, it has much potential. Rather than directly attacking the tumor cells, VEGF inhibitors starve the tumor cells of the nutrition required for tumor cell growth by blocking the nutrition supply pathway. Due to this mechanism of action, it goes well with other anticancer drugs and also pairs well with the cancer immunotherapies that are expanding influence in the anticancer drug market. LG Chem has long been interested in advancing into the global market through new drug development. For this, the company established a local research center in the US 22 years ago, and also invested USD 5 million in a US bioventure for the development of an anticancer drug. Also, the company has spared no amount in R&D, with its company’s R&D-to-Total-revenue ratio reaching nearly 20%. The company was also the first Korean company to obtain approval for a new drug from the U.S. FDA. However, with new drug development being quite challenging in itself and management problems, LG Chem could not succeed in global expansions. LG Chem’s Life Sciences division was unable to continue the development of new drugs in the process of spin-offs, restructuring, and statutory mergers, and also lost a large number of professional personnel. Then, after absorbing LG Life Sciences in 2016, LG Chem restarted its attempt to advance into the global pharmaceutical market. The company secured cash cows – diabetes treatments, fillers, vaccines – to invest in new drug pipelines for autoimmune diseases, anticancer drugs, nonalcoholic steatohepatitis, etc. LG Chem owns 23 new drug and vaccine pipelines. Also, the company has recently started a global Phase III trial for a new gout drug candidate it has been developing. The trial is set to be conducted in the US, China, and Europe. In the field of oncology, the company opted to acquire a biotech. Of course, LG Chem already owns an in-house oncology drug pipeline that consists of 7 candidate substances. However, their development is not so easy as all are in the early stages of Phase I trials, and the company does not have much experience in developing anticancer drugs. Aside from the huge cost, even big pharmas with extensive commercialization experience, often discontinue the development of anticancer drugs midway. The acquisition of AVEO Pharmaceuticals will be an opportunity for LG Chem to understand all areas of anticancer drug development, approval, and sales. In addition to acquiring expert personnel that develops anticancer drugs, the company will be able to acquire the development know-how of big pharmas that have been conducting joint research with Aveo. Also, by transferring its own cancer pipeline to AVEO in the future, the company will be able to conduct global clinical trials more effectively. With the initiation of a global Phase III trial and the acquisition of AVEO this year, LG Chem made a big leap forward in advancing into the global market. Whether LG Chem's two-track strategy will bear fruit will remain to be seen.
- Company
- LG Chem acquires US pharma company for KRW 800 billion
- by Chon, Seung-Hyun Oct 19, 2022 05:49am
- LG Chem will invest KRW 800 billion to acquire a US bio-company. With the acquisition, the company will also be securing an anticancer drug that is being sold in the US. On the 18th, LG Chem announced that it would acquire AVEO Pharmaceuticals for $566 million (approx. KRW 800 billion). LG Chem will be acquiring a 100% stake in AVEO Pharmaceuticals, a company known for its FDA-approved renal cell carcinoma treatment ‘Fotivda.’ This will be the first time a Korean company acquires a company that owns an FDA-approved new drug. AVEO Pharmaceuticals was established in Boston, MA in 2002. It owns full capabilities ranging from clinical development, approval, sales, and marketing in the oncology market. Listed on the Nasdaq in 2010, the company received FDA approval for its targeted therapy Fotivda for the treatment of renal cell carcinoma in 2021. AVEO Pharmaceuticals is expected to record sales of KRW 150 billion this year, which will abe a threefold year-on-year growth. If the ongoing clinical trial that is evaluating Fotivda in combination with an immuno-oncology drug becomes successful, Fotivda’s indication will expand, raising expectations for its further growth. LG Chem will use its assets to finance the funds for the acquisition to LG Chem Life Science Innovation Center (LG CBL), which is based in Boston, US. LG CBL will then establish a special purpose corporation (SPC) to proceed with the M&A of AVEO Pharmaceuticals. The overall deal is expected to be completed in around 3-6 months, after receiving majority approval from AVEO’s general shareholders' meeting and undergoing deliberation by the Committee on Foreign Investment in the United States. LG Chem said, “With the acquisition, we will be able to secure anticancer commercialization capabilities in the US in a short period of time while establishing a bridgehead to launch various in-house new drugs to the US, the world’s largest pharmaceutical market.” LG Chem made the decision to acquire AVEO Pharmaceuticals, a company that has successfully entered the commercialization stage, as it is possible to operate a business in oncology with a sales organization that focuses around on a small number of medical institutions specializing in cancer. Fotivda received a Category 1 Recommendation in the NCCN Guidelines in August and was evaluated to have settled in the renal cell carcinoma treatment market. In addition to Fotivda, AVEO Pharmaceuticals also owns 3 oncology pipelines including the head-and-neck cancer treatment that is undergoing a Phase III clinical trial, etc. LG Chem has a total of 20 new drug pipelines in the development stage, which includes 9 oncology pipelines including cell therapies in solid cancer, as well as treatments for gout, NASH, and obesity. LG Chem plans to accelerate market entry from the beginning of the launch of its new drugs by securing U.S. commercialization capabilities early on. LG Chem aims to record KRW 2 trillion in sales in Life Sciences by 2027 by internalizing AVEO’s commercialization and clinical capabilities. Ahk Cheol Shin, Vice Chairman & Chief Executive Officer at LG Chem, said, “This acquisition decision is the most important milestone in the 40-year history of LG Chem’s biology business. It will lay the foundation for the business to take the global leap forward. We will continue to strengthen commercialization capabilities in the US and actively expand local sales while further enhancing our clinical and licensing capabilities in the US to accelerate our advance into a global innovative pharmaceutical company.”
