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- 2026-05-11 12:01:48
- Policy
- Welireg·Camzyos are approved in Korea
- by Lee, Hye-Kyung May 25, 2023 05:46am
- Welireg, a treatment for von Hippel-Lindau and VHL disease characterized by multiple tumors, and Camzyos, which is used to improve motor function and symptoms in patients with NYHA class II-III obstructive hypertrophic cardiomyopathy, received domestic product approval. It announced on the 24th that it had approved Welireg of MSD Korea and Camzyos of BMS Korea. First of all, Welireg is a drug that inhibits HIF-2α related to cell proliferation, angiogenesis, and tumor growth. It can reduce the risk of surgical excision of the tumor. Hippel-Lindau disease is a rare disease in which incurable multiple tumors occur in the kidney, central nervous system, and pancreas due to mutations in tumor suppressor genes. This drug is used for the treatment of renal cell carcinoma, central nervous system hemangioblastoma, and pancreatic neuroendocrine tumor that does not require immediate surgery in adult patients with von Hippel-Lindau disease, providing new treatment opportunities for patients with these rare diseases. Camzyos is the first treatment for symptomatic obstructive hypertrophic cardiomyopathy in Korea and is expected to provide a new treatment opportunity for patients who have previously used only symptomatic therapy to relieve symptoms. Camzyos has been approved for 4 doses (2.5mg, 5mg, 10mg, 15mg) and relieves excessive contraction of the heart muscle by inhibiting cardiac myosin, and is effective in improving the motor function and symptoms of the patient. The Ministry of Food and Drug Safety said, "We will continue to do our best to expand treatment opportunities for patients with rare and intractable diseases by promptly supplying treatments whose safety and effectiveness have been sufficiently confirmed based on regulatory scientific expertise."
- Company
- BMS’s oHCM drug Camzyos approved in Korea
- by Jung, Sae-Im May 25, 2023 05:46am
- BMS Korea (Country Manager: Hye Young Lee) announced on the 24th that the Ministry of Food and Drug Safety has approved the company’s obstructive hypertrophic cardiomyopathy (oHCM) treatment ‘Camzyos (mavacamten)’ to treat adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (oHCM) to improve exercise capacity and symptoms. Camzyos is the first and only FDA-approved cardiac myosin inhibitor that specifically targets excess myosin actin cross-bridge formation, which is the main cause of oHCM. Camzyos can improve left ventricular hypertrophy and left ventricular outflow tract obstruction by separating myosin from actin and relaxing the over-contracted heart muscle. oHCM is a rare disease that occurs when the left ventricular muscle of the heart becomes abnormally thick, obstructing blood flow through the aorta to the rest of the body. Its main symptoms are shortness of breath, dizziness, chest pain, fainting, etc., which appear in various ways and can increase the risk of various cardiovascular complications such as heart failure and atrial fibrillation. It can cause sudden cardiac death during exercise, especially in young adults and children aged 10 to 35 years. There had remained a high unmet need for the treatment oHCM as its treatment focused more on symptom relief than fundamental cure. Treatment options such as beta-blockers and non-dihydropyridine calcium channel blockers can reduce the heart rate and myocardial contractility, but it is difficult to expect long-term improvement with these existing drug treatment options alone. In addition to this, other available options involve surgically removing the enlarged myocardium or injecting alcohol to cause necrosis of the muscle area, but such procedures are performed to a limited extent due to high risk. Sang-Chol Lee, Professor of Cardiology at Samsung Medical Center, said, “oHCM is a serious and rare condition that can even cause sudden cardiac death without warning. We had much difficulty with its treatment as no effective method of treatment had been available for the non-invasive treatment of the enlarged heart structure, which led to patients experiencing worsening symptoms. Camzyos is the first cardiac myosin inhibitor that specifically targets the source of oHCM. The drug, which only needs to be administered orally once a day, showed excellent symptom improvement effect from the beginning of treatment, and is expected to help restore the quality of life for our patients.” The Phase III EXPLORER-HCM trial, which served as the basis for approval, Camzyos demonstrated statistically significant improvements in heart function and exercise capacity compared to placebo. In the trial, the composite primary endpoint was set as the proportion of patients who achieved either an improvement of mixed venous oxygen tension (pVO2) plus maintenance or improvement in NYHA class. Trial results showed twice more patients receiving Camzyos achieved the primary endpoint compared to the placebo. In particular, 20% of the patients that received treatment with Camzyos achieved both primary endpoints, pVO2 improvement, and the NYHA class requirement, and the heart function of half of those patients treated with Camzyos had improved to Class I, the mildest stage. The treatment effects of Camzyos remained consistent throughout the study for 30 weeks. Also, the left ventricular outflow tract (LVOT) gradient improved to the extent that 70% of the patients would not consider surgery. The proportion of patients who improved below the LVOT pressure difference of 50mmHg, which is the standard considered for surgery, showed a large difference of more than 50%, with 74% in the Camzyos arm and 21% in the placebo arm. The proportion of patients who improved to less than 30 mmHg, which is even lower, was also 57% in the Camzyos group, which was higher than the 7% in the placebo group. BMS Korea’s Country Manager Hye Young Lee, said “We are pleased to be able to provide a fundamental treatment benefit with Camzyos for Korean patients with oHCM who have been experiencing worsening symptoms, to the extent that patients had difficulty continuing on their daily life and were at risk of sudden death. We hope that the approval of Camzyos will be able to contribute not only to the treatment of domestic oHCM patients but also to restore their normal daily life," he said.
- Company
- Latecomer new CML drug Bosulif attempts reimb in Korea
- by Eo, Yun-Ho May 25, 2023 05:46am
- The latecomer leukemia treatment ‘Bosulif’ is attempting to receive reimbursement in Korea. According to industry sources, Pfizer Korea submitted an application for its Chronic Myelogenous Leukemia (CML) treatment Bosulif (bosutinib), and is receiving a review for its reimbursement. The drug, which was approved in January in Korea, was rather late in entering Korea after it was approved by the U.S. FDA in 2012. Bosulif is a 2nd generation targeted anticancer therapy like Novartis Kroea’s ’ ‘Tasigna (nilotinib),’ BMS Korea’s ‘Sprycel (dasatinib),’ Il-Yang Pharamceutical’s ‘Supect (radotinib)’. With so many drugs already on the market, no major difficulties are expected in Bosulif’s reimbursement process. Bosulif’s safety and efficacy were verified through a Phase III trial (NCT02130557) that was conducted on patients with newly-diagnosed Ph+ CML. The major efficacy outcome measure was the major molecular response (MMR) at 12 months. Results showed that MMR at 12 months was 47% in the Bosulif arm. The MMR in the comparator arm, which administered the 1st generation drug Glivec (imatinib), was 36%. MMR at 60 months was 74% in the Bosulif arm and 66% in the Glivec arm. The median time to MMR in respondents after 60 weeks of follow-up was 9.0 months in the Bosulif arm and 11.9 months in the Glivec arm In the market, next-generation CML-targeted anticancer drugs are already entering the market. Otsuka Pharmaceutical Korea’s Iclusig (ponatinib)’ is a 3rd generation treatment, and Novartis Korea’s Scemblix (asciminib) is available as a 4th generation treatment. Iclusig was listed for reimbursement in Korea in 2018, and Scemblix passed the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee in April and the company is conducting drug pricing negotiations with the National Health Insurance Service.
- Company
- Seven times stricter standards
- by Chon, Seung-Hyun May 25, 2023 05:46am
- Panoramic view of the Ministry of Food and Drug Safety Health authorities have prepared new standards for managing impurities in Januvia, a diabetes treatment. Prior to the release of Januvia generics, pharmaceutical companies were requested to only ship products within the newly set standard. Pharmaceutical companies are busy with quality control by presenting a standard that is seven times stricter than the temporary acceptance standard applied at the time of the recall of Januvia impurity products. According to the industry on the 25th, the Ministry of Food and Drug Safety recently sent an official letter to pharmaceutical companies with instructions on safety measures and information on nitrosamine impurities in drugs containing ‘sitagliptin’. The MFDS determined that the nitrating agent among the additives of Sitagliptin generated the impurity NTTP during the manufacturing or storage process of the finished drug. It means that it has a chemical structure in which impurities are generated during the manufacturing process of sitagliptin. It suggested the permissible daily intake of Sitagliptin NTTP as 37ng and instructed pharmaceutical companies to implement safety measures. The MFDS ordered, “We will conduct an NTTP test and inspection for impurities and only ship products within the permissible daily intake (37ng/day), and if impurities are detected as a result of the test, we will take step-by-step measures according to the level of detection.” The MFDS ordered pharmaceutical companies to conduct stability tests so that the NTTP can be managed at 30% or less of the acceptable standard during the period of use of the finished product of sitagliptin. In case the standard is exceeded or there is a concern, it is instructed to immediately report it to the Ministry of Food and Drug Safety. Sitagliptin is a DPP-4 inhibitory diabetes treatment, and MSD's Januvia is the original drug. Recently, Chong Kun Dang acquired the domestic sales rights of Januvia. After Januvia's patent expires in September, domestic pharmaceutical companies are preparing to release generics. In other words, the Ministry of Food and Drug Safety presented the impurity control standard before the release of Januvia generics and started a preliminary inspection. The danger of impurities in Januvia was raised last year. In August of last year, the European Medicines Agency (EMA) instructed Januvia to investigate the possibility of detecting a new NTTP impurity. As a result of MSD's impurity analysis at the time, NTTP was found, but it was not detected above the standard level, so it did not lead to a recall action. In Korea, in March, MSD Korea voluntarily recalled two lot numbers (U010253, U012914) of ‘Januvia 50mg’. At the time, MSD Korea said, "The NTTP level detected in Januvia slightly exceeds the temporary release standard (maximum 246.7ng/day)." The Ministry of Food and Drug Safety suggested 246.7ng/day as the standard for the temporary release of Januvia, and Januvia exceeded this standard and voluntarily recalled it. The limit for sitagliptin impurities set by the Ministry of Food and Drug Safety this time is 37 ng/day, which is one-seventh of the temporary release standard applied at the time of Januvia recovery. This means that the standard was set seven times stricter than the temporary release standard. If Januvia's recalled product was detected with NTTP at the temporary release standard level, it means that it exceeded the standard set by the Ministry of Food and Drug Safety by about 7 times. An official from the Ministry of Food and Drug Safety said, “The temporary acceptance standard is a standard that is applied when there is a concern about the supply disruption of the drug.” Explained. This means that the NTTP standard for sitagliptin has been set based on the same standard as other medicines because there is no problem with drug supply and demand even if impurities problems arise in some products when Januvia generics are poured out. It is known that many pharmaceutical companies conducted sitagliptin NTTP quality control based on temporary release standards. However, as the standard proposed by the Ministry of Food and Drug Safety is seven times stronger than the temporary acceptance standard, pharmaceutical companies are forced to conduct NTTP inspections according to more stringent standards. Since impurities in Sitagliptin preparations must be controlled within 30% of the allowable limit during the period of use, pharmaceutical companies complain that the quality control standards have become too strict. Some companies have begun adjusting their impurity quality control plans as the Ministry of Food and Drug Safety presents stricter standards than those set by itself. According to the Ministry of Food and Drug Safety, 100 domestic pharmaceutical companies have approved 715 products containing Sitagliptin and are waiting for the release date. According to UBIST, a pharmaceutical research institute, a total of 109.4 billion won in outpatient prescriptions for sitagliptin-containing drugs was jointly made last year. Januvia and Janumet raised 40.5 billion won and 68.9 billion won, respectively. As Januvia is forming a large market, domestic pharmaceutical companies are preparing to enter the generic market indiscriminately.
- Company
- Leading companies in developing new PO microbiome drugs
- by Nho, Byung Chul May 24, 2023 08:28pm
- The next-generation microbiome, Akkermansia muciniphila, was observed under an electron microscope (photo by Enterobiome) Recently, the world's first oral microbiome treatment obtained approval from the US Food and Drug Administration (FDA). VOWST from Seres Therapeutics in the U.S. is a drug that prevents re-infection after antibacterial treatment for CDI bacteria for people over 18 years of age. As a new microbiome drug, it is the second after Rebyota of Ferring Pharmaceuticals of Switzerland, but if the treatment was an anal-administered drug, VOWST is significant in that it is the first oral formulation treatment of a related drug. As microbiome new drugs are approved one after another, domestic microbiome companies are also accelerating the development of new drugs for various indications based on each company's microbial strain pipeline. The microbiome is a combination of microbe and biome and refers to various microorganisms living in the human body and their genes. Microbiome treatment is one of the fields that many biopharmaceutical companies are challenging because it is based on microorganisms and has the advantage of higher safety than other treatments. Genome & Company's GEN-001 is a microbiome-based immuno-anticancer drug made in an oral formulation by improving a single strain of Lactococcus lactis isolated from the intestine of a healthy person and has currently obtained a domestic patent. GEN-001 acts as a mechanism to activate the body's immunity and is currently conducting phase 2 clinical trials for gastric cancer in combination with Bavencio, an immuno-oncology drug from Merck and Pfizer. In the case of MSD's phase 2 clinical trial of Keytruda, an anticancer drug for biliary tract cancer, it is currently applying for approval to change its IND (clinical trial plan) to the Ministry of Food and Drug Safety, and patients are scheduled to be administered in the second half of this year. KoBioLabs' KBL697 is a Lactobacillus gasseri monostrain substance with an anti-inflammatory immunomodulatory mechanism and is currently patented in the US. The strain is undergoing global phase 2 clinical trials in the US and Australia, targeting psoriasis (KBLP-001) and ulcerative colitis (KBLP-007) caused by an excessive immune response. KBLP-007 recently received IND approval from the Ministry of Food and Drug Safety, which includes Korea for phase 2 clinical trials and is about to proceed with domestic clinical trials. Some companies are developing microbiome treatments using new strains that have not been registered with the Ministry of Food and Drug Safety in Korea. Enterobiome's EB-AMDK19 is Akkermansia muciniphila, a non-notified strain of Akkermansia muciniphila that is non-cultivable and extremely anaerobic that lives in the intestinal mucosa of the body and shows efficacy in diseases such as metabolic and immune diseases. Akkermansia muciniphila, also known as next-generation probiotics, is an extremely anaerobic bacterium that is extremely sensitive to oxygen and requires advanced culture technology because it is difficult to isolate, identify, and culture. Enterobiome has completed the registration of a 'patent for high-yield cultivation technology of anaerobic bacteria' in the United States, Australia, India, and Canada, starting with Korea, and holds six patents related to the EB-AMDK19 strain. The strain has completed the GLP non-clinical toxicity test and is currently scheduled to apply for an IND targeting atopic skin disease in the first half of next year.
- Policy
- Domestic medical device market share ↑50%
- by Lee, Hye-Kyung May 24, 2023 08:26pm
- The share of domestically produced medical devices exceeded 50%. It is believed that the reason is that the production of medical devices such as in vitro diagnostic devices increased as public health medical products were approved for emergency use after Corona 19. Chae Gyu-han, head of the Medical Device Safety Bureau of the Ministry of Food and Drug Safety, said at a press briefing on the 23rd, “We are analyzing the production status of the medical device industry last year, and the market share of domestic manufactured products exceeded 50%.” It means that we can concentrate on producing essential medical devices for public health when an outbreak occurs and create a system that can stably supply them.” Therefore, the Ministry of Food and Drug Safety has expressed its will to improve the system so that companies with competence do not enter the market due to a lack of licensing experience. Manager Chae said, “The core of Regulatory Reform 2.0, which will be announced soon, is to ensure that the medical device industry develops in line with changes in the policy environment.” " said. Although the domestic medical device industry has developed due to the specificity of COVID-19, it is said that the content of Regulatory Innovation 2.0 will be to prepare an evaluation system to create international-level medical products with prepared technology and experience and to lead the medical device market. While Aimmed's 'Soames' and Welt's 'PillowRx' were recently approved as the 1st and 2nd digital treatment devices (DTx), it also indicated that it would prepare for the development of AI big data-based digital medical products in the future. Manager Chae said, "Deputy Director Oh Yoo-gyeong is also very interested in AI-based medical product development. The Power of the People Rep. Jong-heon Baek and Young-seok Seo of the Democratic Party each proposed the 'Digital Medical Products Act as part of this concern. The bill defines digital medical devices, digital convergence medicines, and digital medical and health support devices as digital medical products prepares an evaluation system and evaluates actual use, introduces an excellent management system certification system, and provides preferential treatment for health insurance benefits. there is. Manager Chae said, "It is expected that the bill will be discussed in the legislative subcommittee, and the management system has been established in line with the era of digital transformation so that digital technology can be applied to medical devices and medicines and used for health care." We will make it legislative,” he said. In line with the enactment of the bill, the Ministry of Food and Drug Safety is also preparing guidelines for the development of digital treatment devices. Manager Chae said, "Even before the legislation, we will prepare guidelines necessary for clinical trials and the development of digital treatment devices." In the field of innovative medical devices and innovative diagnostic devices, he emphasized investment support for selection and concentration. Manager Chae said, “There were concerns about the growth of overall medical devices and the growth of specialized fields, and as a result of conversations with the industry, there were many opinions that selection and concentration were needed.” “I think innovative medical devices and diagnostic devices have competitiveness. We plan to develop areas that can be developed and promote measures such as intensive support.” "Regulatory Innovation 2.0 and the promotion of the Digital Medical Products Act are one of the important projects this year," said Joo Seon-tae, head of the Medical Device Policy Department, who was present at the briefing of the Director of the Medical Device Safety Bureau. did. Seong Hong-mo, head of medical device management, said that she is promoting a project to prepare braille and sign language videos for medical devices to improve information access for the disabled. He said, "The recently revised bill contains information related to information accessibility for the disabled, and it will be a recommendation, not an obligation." He added, "If the sub-law is enacted, it will be conducted by meeting with disabled groups, investigating products that require braille or sign language videos, and recommending them to companies."
- Company
- Pharma industry on alert over business risks in China
- by Lee, Seok-Jun May 24, 2023 05:32am
- Business risks related to China have been rising in Korea’s pharmaceutical industry. There are many causes, including the termination of the contract for supplying medicines (or cosmetics), liquidation of Chinese subsidiaries, and claims for damages, etc. Most of them are due to the failure of their Chinese partners in fulfilling their promises. On the 22nd, Ahn-Gook Pharmaceutical publicly announced that it had requested the termination of its supply contract to the Chinese company (Sichuan Wanhe Chinese Medicinal Decocting Pieces PLC) it had signed a supply contract with for its ‘Anycough Cap’. The original contract term was 10 years from when the company receives the Import Drug License for Anycough Cap. However, the Import Drug License was not approved due to the other party's non-fulfillment of the contract, which was the grounds for the termination. The contract was worth KRW 26.9 billion at the time of its signature. Il-Yang Pharmaceutical is liquidating its key OTC Chinese subsidiary. On the 15th, Il-Yang Pharmaceutical publicly announced that it had decided to dissolute and liquidate its subsidiary 'Tonghwa Ilyang Health Products Co., Ltd.’ to increase management efficiency. The industry pointed to the company’s conflict with its partner as the cause. The company announced that it was unable to settle the dissolution by agreement, and plans to proceed with the dissolution procedure with the competent court. By shares, Tonghwa Il-Yang is 45.9% owned by Il-Yang Pharmaceutical, 19.4% by Il-Yang Pharmaceutical’s owner family Do-eon Jeong and affiliates, and 34% by Tonghua City in China. The dissolution was decided upon due to a conflict with the Chinese city. Tonghwa Ilyang was a profit-raising company that posted sales of KRW 40.4 billion and an operating profit of KRW 19 billion last year. Its good profitability also played a positive role in the consolidated performance of Il-Yang Pharmaceutical In addition, Dong Sung Bio Pharm terminated its overseas distributor contract for Rannce brand products in early May. The termination will be worth KRW 8.5 billion, excluding the KRW 6.5 billion payment made for contract fulfillment from the original contract’s worth, which was KRW 15 billion. The other party, Artface had planned to supply the Rannce brand to China and other countries. However, the contract was terminated due to the other party’s non-compliance with the minimum performance amount in the contract. Korea United Pharm also announced the termination of the supply contract for Clanza CR tablets worth KRW 40.9 billion in December last year. This is a measure following China's JJK's failure to fulfill its contract. Also, Medytox’s Chinese joint venture is on the verge of dissolution. Its partner, Gentix sued Medytox earlier this year for contract violation. The company also filed a claim for damages worth KRW 118.8 billion, claiming that there was a problem with the terms of the JV contract. Medytox had established the joint venture, MedyBloom China, with Bloomage Biotechnology in 2016 with a 50:50 stake. Medytox, which invested KRW 7.2 billion, judged that there was no violation of the contract on its side and is responding through legal representation. As risks arise in the Korean pharmaceutical industry's business with China, the feasibility of the contracts made by other pharmaceutical companies in China is also drawing attention. In June 2017, Seoul Pharmaceutical signed a KRW 111.1 billion contract with a Chinese company to sell and supply orally disintegrating strips for the treatment of erectile dysfunction. The amount of KRW 111.1 billion was set as the supply price based on US dollars for the quantity agreed upon by the two companies for a total of 10 years after the drug’s approval by the CFDA in China. This is a conditional amount that can only be generated if the drug is approved in China. However, no separate announcement has been made so far on its approval. A market insider pointed out, "There are many cases where businesses in China fall apart due to the partners' failure to fulfill contracts. This is why business is often delayed and contracts are broken."
- Product
- The expansion of OTC medicine at convenience stores
- by Kim JiEun May 24, 2023 05:32am
- As safe household medicines enter their 10th year of introduction, public opinion is forming that the items and places where they can be used should be expanded with the weapon of ‘resolving the gap in medicines and strengthening access rights’. Starting with the application for a special case for demonstration of safe household medicine unmanned vending machines last year, organizations are moving in earnest to improve access to medicines, such as expanding household medicine items, based on public opinion. Currently, an application for the installation of an unmanned vending machine for safety and emergency medicine is being applied for in the regulatory sandbox of the Ministry of Trade, Industry, and Energy, and an expert advisory meeting and deliberation are ahead. After going through the first expert advisory committee meeting at the end of last year, it is pending, and if the second expert meeting is held, the possibility that the pilot project will be passed at the plenary meeting cannot be ruled out. Recently, an association of civic groups calling for the expansion of safety and household medicine items has been created and is attracting attention. The group, which started its activities under the name of ‘Citizens’ Network for Safe Household Medicines’, plans to begin its official activities on the 30th, starting with the ‘Press Conference to Announce the Results of Public Demand Survey for Safe Household Medicines in Convenience Stores’. The demand survey to be announced on this day was conducted in advance by a civic group called 'Consumer Public Interest Network', which participated as a safety deliberation member on behalf of civic groups at the 2018 Safety Household Medicine Designation Deliberation Committee. It was also the organization that claimed it. In addition, the Korea Chamber of Commerce and Industry, which has consistently insisted on the need for remote dispensing and drug delivery, is also conducting a public opinion poll to improve drug access. The Korea Chamber of Commerce and Industry (KCCI) announced that after the revision of the Pharmaceutical Affairs Act, which allowed the sale of household medicines at convenience stores, sales of safe household medicines nearly tripled. The Korean Chamber of Commerce and Industry argues that it is necessary to improve access to medicines in order to strengthen the right to public health, and as a solution in this survey, ▲extended operation of pharmacies until 9:00, ▲Introduction of unmanned vending machines for safe household medicine, ▲Expansion of installation of remote video dispensing machines, ▲Designation of 24-hour pharmacies as regional bases, etc. also presented. The Korean Pharmaceutical Association is closely watching these movements of organizations that have set out to form a public opinion with accessibility and convenience as their weapons. An official from the pharmaceutical association said, “We are currently aware of the related content and are discussing countermeasures.” The official also said, “With regard to the application for a special case for demonstration of an unmanned vending machine for household medicine, there has been no special progress since the deliberation was suspended.”
- Company
- Leclaza posts sales of KRW 25 bil in 2 years in Korea
- by Chon, Seung-Hyun May 24, 2023 05:32am
- Yuhan Corp’s anticancer drug ‘Leclaza’ is making good sales in the Korean market, and raised sales of KRW 5.1 billion in Q1 alone. Its efficacy and safety were confirmed in the real world in actual patients at the time of treatment, and the drug is gradually expanding its market influence ahead of its approval as a first-line treatment. According to the market research institution IQVIA on the 23rd, Leclaza’s sales were KRW 5.1 billion in Q1, up 57.4% YoY. It is also a 12.9% increase from the KRW 4.5 billion made in the previous quarter. Leclaza is an NSCLC treatment that was approved as the 31st homegrown novel drug in January last year. It is a 3rd generation EGFR TKI that inhibits the proliferation and growth of lung cancer cells. It is currently approved as a treatment for patients with locally advanced or metastatic NSCLC who developed resistance after being previously treated with 1st generation or 2nd generation EGFR-TKIs. The drug entered the market in earnest after being listed for reimbursement in the National Health Insurance Service in July 2021. The drug recorded sales of KRW 1.5 billion and KRW 2.6 billion in Q3 and Q4, respectively. Last year, its quarterly sales had risen to the KRW 4 billion range, and continued growing this year. Cumulative sales made during the 2 years since the release of Leclaza totaled KRW 25.2 billion. Leclaza Leclaza posted sales of KRW 16.1 billion last year, breaking the sales record made by homegrown new anticancer drugs in Korea. Other homegrown new anticancer drugs that were approved before Leclaza include Il-Yang Pharmaceuticals’ Supect, Dongwha Pharm’s Milican, Chong Kun Dang’s Camtobell, Sam Sung Pharmaceutical’s Riavax, Hanmi Pharmaceutical’s Olita. None of the products have exceeded annual sales of KRW 10 billion. At the current rate, Leclaza may likely exceed annual sales of KRW 20 billion this year. Leclaza is considered to have made a smooth start in the market. Anticancer drugs that are usually used in large medical institutions, can only be prescribed after the drug passes each institution’s drug committee, therefore, it takes a considerable amount of time before sales are generated after the initial stage of release. With the added pressure of having to directly compete with outstanding new drug products from multinational pharmaceutical companies, it is not easy for new anticancer drugs developed in Korea to achieve commercial results. Leclaza passed the drug committee of major large medical intuitions in Korea and is accelerating its market penetration efforts. The drug is expected to expand further into the market if it receives approval in the first line. In March, Yuhan Corp applied for approval of Leclaza as a first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer with EGFR exon 19 deletion or exon 21 (L858R) substitution mutation to the Ministry of Food and Drug Safety. Leclaza demonstrated its efficacy over existing treatments in a global Phase III trial (LASER 301) that was conducted on 393 locally advanced or metastatic NSCLC patients with EGFR mutations. The trial results had been presented at the European Society for Medical Oncology Congress that was held last year in Singapore. The company has also been accumulating evidence of its efficacy and effect in the real world. Lim Sun Min, Professor of Oncology at Yonsei Cancer Center, and Beung-Chul Ahn, Professor of Oncology at the National Cancer Center, recently published real-world data (RWD) on how Leclaza confirmed its safety and efficacy in practice in the journal, Lung Cancer. This was the first-ever real-world study results announced since Leclaza’s approval, The research team conducted a retrospective study on 103 patients with EGFR T790M mutation-positive NSCLC patients who developed resistance after being previously treated with EGFR-TKI that received Leclaza from January 2021 to August 2022 at Yonsei Cancer Center and the National Cancer Center. 90 of the 103 patients received Leclaza as a second or third-line treatment. The patients’ primary efficacy endpoint in the study, median progression-free survival (mPFS), was 13.9 months. This was consistent with the mPFS of 11.1 months confirmed in LASER201, the study that became the basis of Leclaza’s approval. The objective response rate (ORR) was 62.1%, slightly higher than the 55.3% observed in the LASER201 study. In terms of safety, the drug was also well-tolerated, similar to previous studies. The research team explained, “ The real-world study reaffirmed the consistent effect and efficacy of Leanza as a second-line treatment for EGFR T790M mutation-positive NSCLC patients in practice.” Yuhan Corp has invested a total of KRW 93 billion in the Phase III trial for Leclaza. According to the Financial Supervisory Service, as of the end of the first quarter, Yuhan Corp reflected KRW 93 billion of Leclaza’s development cost as intangible assets. In 2019, the Financial Supervisory Service set a standard that only R&D projects that have technical feasibility, including those for new drugs, shall be accepted as accounting assets. The FSS suggested that R&D costs can be turned into assets after initiating Phase III trials for new drugs and receiving approval for its Phase I trial for biosimilars. As for generic drugs, they can be capitalized after their bioequivalence test plan is approved. Under such standards, Leclaza’s development costs of KRW 32.6 billion were first recognized as intangible assets in Q4 2020. Its development costs were reflected as intangible assets after its Phase III trial began in earnest. Leclaza’s development cost intangible asset increased to KRW 61.4 billion by the end of 2021, and then rose to KRW 88 billion last year, with the added KRW 26.6 billion last year. In Q1 this year, an additional KRW 5 billion was invested as clinical expense.
- Company
- Merck retrieves rights to PD-L1 antibody Bavencio in Korea
- by Eo, Yun-Ho May 23, 2023 05:54am
- The long-standing collaboration that had existed between the Korean subsidiaries of Merck and Pfizer Korea for the immunotherapy ‘Bavencio’ has come to a close. According to industry sources, the companies are in the process of handling the rights for the PD-L1-inhibiting immunotherapy Bavencio (avelumab) in Korea as Merck retrieved the global rights for the drug. As a result, Pfizer Korea’s Bavencio-related personnel (marketing, sales) will also be reassigned to different posts. The two companies have jointly developed and marketed Bavencio after forging a partnership in 2014. Also, the ongoing processes for expanding reimbursement to the first-line in urothelial cell cancer will be carried out by Merck Korea alone from now on. Currently, Bavencio passed the Health Insurance Review and Assessment Service’s Cancer Disease Review Committee review in April last year, but no news has yet been heard on its deliberation by the Drug Reimbursement Evaluation Committee. Bavencio was first approved in Korea as a monotherapy to treat adult patients with metastatic Merkel cell carcinoma (mMCC) in 2019. The indication was granted insurance reimbursement in October 2020. Since then, the drug has additionally been approved as a first-line maintenance monotherapy in August 2021 for patients with locally advanced or metastatic urothelial carcinoma who have not progressed after using platinum-based chemotherapy. Pfizer, which let go of its rights for Bavencio, announced its plans to acquire the anticancer drug company Seagen. This merger between Pfizer and Seagen, which was officially announced in March, is worth USD 43 billion (about KRW 56 trillion) and is considered to be the largest among global pharMaceutical and bio-industry M&A transactions this year. Known for its global expertise in antibody-drug conjugates (ADC), Seagen is considered a leader in the new drug development industry. Its oncology pipeline has 4 anticancer drugs: Adcetris, Padcev, Tivdak, and Tukysa. Pfizer expects the merger to bring sales growth through royalties and collaboration related to the development of ADC anticancer drugs.
