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- 2026-03-17 02:03:10
- Company
- Hanall Biopharma to expand HL161 development in earnest
- by Chon, Seung-Hyun Jun 10, 2022 05:44am
- Hanall Biopharma announced on the 9th that its U.S. partner Imunovant will expand the development of HL161 (code name IMVT-1401), which is being developed as a SC autoimmune treatment. Phase 3 clinical trials for severe work history will begin this month and the results of the top line in 2024 will be confirmed. According to Immunovant, there are estimated to be about 66,000 patients with severe work history in the United States. Clinical plans for TED, which were suspended last year, have also been unveiled. Immunovant obtained consent from the U.S. Food and Drug Administration (FDA) for phase 3 clinical trials of HL161. Phase 3 clinical trials are expected to begin in the second half of this year and confirm the results in 2025. Imunovant also unveiled a plan to further expand the indication of HL161 to provide wider treatment options for patients suffering from intractable diseases. By August, three indications, including WAIHA, will be added and phase 3 clinical trials will be launched for one of them. HL161 is the U.S. and European development name of the new antibody drug HL161, which Hanall Biopharma exported to Roivant Sciences in December 2017. It exhibits a mechanism of action to remove pathogenic autoantibodies in the body by inhibiting the 'FcRn' receptor known as the cause of autoimmune diseases. Roivant Sciences has signed a total of $52.5 million contract with Hanall Biopharma on condition that it secures exclusive rights to develop, produce, item licenses, and sell autoimmune disease HL161 in the U.K., Switzerland, the Middle East and North Africa, including the U.S. At the time of the contract, it paid $30 million in deposit (upfront fee), which was not obligated to return, and additional $20 million in research funds and $452.5 million in step-by-step milestones (technical fees). Imunovant decided to voluntarily suspend clinical trials early last year on the grounds that a rise in total cholesterol and LDL-C levels was observed in the HL161 administration group among patients participating in clinical trials 2b. Chung Seung-won, CEO of Hanall Biopharma, said, "HL161 is expected to reduce the burden of medical expenses because it is convenient for patients to take drugs on their own in the form of subcutaneous injections." "We will continue to expand the indication of HL161 to contribute to the lives of more patients," he said.
- Company
- Exports of CKD·Dong-A ST's antianemic biosimilars increase
- by Chon, Seung-Hyun Jun 10, 2022 05:43am
- The biosimilar products developed by Chong Kun Dang and Dong-A ST are starting to make their way into the overseas market, with its Nesp biosimilars starting to generate sales in earnest abroad. Although the companies’ products did not show explosive growth upon entry, the products are increasing their presence in the market. According to the Financial Supervisory Service, Chong Kun Dang’s export sales recorded ₩19.4 billion in Q1 this year, a 57.7% increase compared to sales made in the same period of the previous year. Compared to the ₩10.6 billion it had made in Q1 2020, the scale of exports increase 82.3% in two years. In the case of Chong Kun Dang, the company’s sales had been solely dependent on domestic demand. Its exports in Q1 2019 were a mere ₩6.3 billion. Chong Kun Dang’s ‘Nesbell’ is being highlighted as the driver of CKD’s recent growth in exports. New drug products being developed by Hanmi Pharmaceutical have received a total of 20 orphan drug designations from regulatory authorities in Korea and abroad. Hanmi Pharmaceutical announced on the 9th that the European Medicines Agency granted an orphan drug designation for its new triple action biologic drug LAPS Triple Agonist (HM15211) for the treatment of Idiopathic pulmonary fibrosis (IPF). Idiopathic pulmonary fibrosis is a rare condition caused by an unknown pulmonary inflammatory process and fibroblast hyperproliferation. Patients with IPF experience a rapid decline in lung function from tissue fibrosis and even death. Although it occurs in less than 100 cases per 10,000, its treatment had been rendered difficult due to the lack of efficacy in its approved treatments. LAPS Triple Agonist is a triple-action biologic drug that activates GLP-1, Glucagon, and GIP. It simultaneously targets▲ Glucagon, which inhibits fibrosis ▲ GLP-1, which facilitates insulin secretion and helps suppress appetite, and ▲ GIP, which facilitates insulin secretion and anti-inflammatory effect. Hanmi Pharmaceutical had confirmed its drug’s antiinflammatory and antifibrotic in animal models with idiopathic pulmonary fibrosis. With the designation Hanmi Pharmaceutical received a total of 20 orphan drug designations for its 10 indications in 6 pipelines (9 FDA designations, 8 EMA designations, and 3 Korea MFDS designations). LAPS Triple Agonist received a total of 6 orphan drug designations from both the FDA and EMA for the treatment of ▲primary biliary cholangitis, ▲primary sclerosing cholangitis, and ▲IPF. The FDA and EMA grant orphan drug designations to facilitate smooth development and approval of drugs that treat rare, incurable, or life-threatening diseases. In Europe, drugs that receive the designation pay reduced fees for marketing-authorization applications and may benefit from ten years of market exclusivity once they receive marketing authorization in the European Union (EU) An official from Hanmi Pharmaceutical said, “All the indications that the drug received orphan drug designation on induces fibrosis in specific tissues and has high unmet needs. LAPS Triple Agonist’s designation has meaning in that the drug's innovativeness is receiving attention from regulatory agencies in advanced countries. Nesbell is a biosimilar of the second generation anemia treatment ‘Nesp (darbepoetin-α).’ It is prescribed to treat ▲anemia in chronic kidney disease patients and ▲anemia in patients with solid cancer who receive chemotherapy. Chong Kun Dang received marketing approval from Japan's Ministry of Health, Labor, and Welfare in September 2019. The Japanese subsidiary of U.S. global pharmaceutical company Mylan N.V. is in charge of sales in Japan. Analysts believe that the continued growth of Nesbell’s sales in Japan had driven the continued growth of Chong Kun Dang’s export in Japan. Nesbell holds great significance for the company as it is the first biosimilar that it succeeded in developing. Chong Kun Dang entered the biosimilar market after securing its own platform technology in 2008. After initiating a Phase I trial on Nesbell in 2012, Chong Kun Dang succeeded in becoming the first company to commercialize a biosimilar of Nesp by receiving marketing approval for Nesbell from the Ministry of Food and Drug Safety at the end of 2018. Nesbell is also set to enter the Middle East soon. Chong Kun Dang signed an export agreement for Nesbell with an Oman company Menagene Pharmaceutical Industries in July last year. Under the agreement, Menagene Pharmaceutical Industries will be acquiring the marketing authorization and own the exclusive rights to sell Nesbell in 6 countries in the Middle East, including Oman, Saudi Arabia, Chong Kun Dang starts supplying its finished Nesbell product to United Arab Emirates, Kuwait, Qatar, and Bahrain. The drug is also increasing its presence in the Korean market. According to the market research institution IQVIA, Nesbell’s sales last year amounted to ₩4.8 billion, which was a 150.9% YoY increase. Its sales had only been ₩0.3 billion and ₩1.9 billion in the first year of its release and 2020, respectively. Its sales has risen significantly last year to increase its market share in the same ingredient market to 18.5%. Dong-A ST’s Nesp biosimilar ‘Darbepoetin-α’ is also slowly increasing its influence in the market. After conducting a Phase 1 clinical trial on’ Darbepoetin-α,’ Dong-A ST signed a licensing-out agreement on the development and sale of its drug to Sanwa Kagaku Kenkyusho (SKK). Based on a Phase III trial conducted in Japan to compare the efficacy and safety of ‘Darbepoetin-α’ to the original ‘Nesp,’ SKK received marketing approval from Japan's Ministry of Health, Labor and Welfare for the drug in September 2019 and launched the drug for sale in November of the same year. Dong-A ST exports the finished products which were produced by DM Bio, a biosimilar company under Dong-A Socio Group, to SKK, after which SKK takes charge of its local sales. Darbepoetin-α’s exports increased 13.8% YoY to record ₩3.3 billion in Q1 this year. This is a decrease from the ₩6.1 billion made in Q4 last year, but still has been making ₩3 billion in sales every quarter. Darbepoetin-α had first made ₩1 billion in the first year of its release, which increased to ₩8.8 in 2020. Its sales then exceeded ₩10 billion in annual sales for the first time last year, recording ₩12.5 billion. Darbepoetin-α’s cumulative sales totals at ₩25.6 billion.
- Company
- Sanofi & 4 other companies will participate in NIP
- by Lee, Tak-Sun Jun 10, 2022 05:42am
- Unlike the previous year, Sanofi Pasteur is expected to participate as a new business operator and Ilyang Pharmaceutical is expected to be excluded. As a result of the bidding conducted through the Nara Market of the Public Procurement Service on the 9th, Sanofi Pasteur was selected as the first choice by writing the lowest price of 14,433. The desired quantity is 2.2 million doses.The second ranking is Korea Vaccine, which participated in 16,670 won, and the desired quantity is 1.7 million doses. The third place is Boryung Bio Pharma, which spent 16,887 won, and the desired quantity is 1.8 million degrees. The fourth ranking was GC Pharma, which offered 10,700 won, and the desired quantity was 6 million doses. Ilyang Pharmaceutical has bid 10,700 won, the same as the GC Pharma, but the desired quantity is 1.9 million doses, which is less than the GC Pharma, so it is expected to be pushed back from the priority. In this bid, the bidder until the purchase quantity reaches the lowest price among the bidders at a unit price below the scheduled price shall be the successful bidder. All five companies that participated in the bidding had lower bidding prices than the scheduled price of 10,807 won. The KCDA suggested a total of 10,665,090 doses. Looking at the desired quantity in the order of the lowest price, the three companies will easily be included in the total purchase volume, with 2.2 million doses of Sanofi, 1.7 million doses of Korean vaccine, and 1.8 million doses of Boryeong Biopharma. The combined total number of these companies is 5.7 million. The remaining quantity is about 4.96 million doses, which is expected to be taken by the GC Pharma which wants 6 million doses. Ilyang Pharmaceutical has written the same price as GC Pharma, but if there are more than two bidders of the same price, it will be pushed out of the bidding range because it prioritizes bidders with high bidding volume. However, the final successful bidder is determined according to the qualification for participation in the bid and the results of the qualification examination. However, as these companies have a lot of experience in participating in the free flu vaccination project, it is expected that the successful bidder will be determined according to the results of the ticket gate unless there is an accident. Performance of Sanofi is 22.3 billion won, Korea Vaccine, 18.1 billion won, Boryung Biopharma, 19.2 billion won, and GC Pharma, 53 billion won. Compared to last year, the supply volume is the result of an increase of about 1 million doses of green cross, 400,000 doses of Korean vaccine, and 200,000 doses of Boryung Biopharma. Sanofi, which was absent last year, will be the only foreign pharmaceutical company to participate and be selected as the top priority, and will supply the second largest quantity after GC Pharma. GSK, which supplies Fluarix Tetra PFS, a quadrivalent vaccine aid, will not participate in the NIP business again this time.
- Company
- Hanmi’s new biologic receives orphan designation in Europe
- by Chon, Seung-Hyun Jun 10, 2022 05:42am
- New drug products being developed by Hanmi Pharmaceutical have received a total of 20 orphan drug designations from regulatory authorities in Korea and abroad. Hanmi Pharmaceutical announced on the 9th that the European Medicines Agency granted an orphan drug designation for its new triple action biologic drug LAPS Triple Agonist (HM15211) for the treatment of Idiopathic pulmonary fibrosis (IPF). Idiopathic pulmonary fibrosis is a rare condition caused by an unknown pulmonary inflammatory process and fibroblast hyperproliferation. Patients with IPF experience a rapid decline in lung function from tissue fibrosis and even death. Although it occurs in less than 100 cases per 10,000, its treatment had been rendered difficult due to the lack of efficacy in its approved treatments. LAPS Triple Agonist is a triple-action biologic drug that activates GLP-1, Glucagon, and GIP. It simultaneously targets▲ Glucagon, which inhibits fibrosis ▲ GLP-1, which facilitates insulin secretion and helps suppress appetite, and ▲ GIP, which facilitates insulin secretion and anti-inflammatory effect. Hanmi Pharmaceutical had confirmed its drug’s antiinflammatory and antifibrotic in animal models with idiopathic pulmonary fibrosis. With the designation Hanmi Pharmaceutical received a total of 20 orphan drug designations for its 10 indications in 6 pipelines (9 FDA designations, 8 EMA designations, and 3 Korea MFDS designations). LAPS Triple Agonist received a total of 6 orphan drug designations from both the FDA and EMA for the treatment of ▲primary biliary cholangitis, ▲primary sclerosing cholangitis, and ▲IPF. The FDA and EMA grant orphan drug designations to facilitate smooth development and approval of drugs that treat rare, incurable, or life-threatening diseases. In Europe, drugs that receive the designation pay reduced fees for marketing-authorization applications and may benefit from ten years of market exclusivity once they receive marketing authorization in the European Union (EU). An official from Hanmi Pharmaceutical said, “All the indications that the drug received orphan drug designation on induces fibrosis in specific tissues and has high unmet needs. LAPS Triple Agonist’s designation has meaning in that the drug's innovativeness is receiving attention from regulatory agencies in advanced countries.
- Company
- Jeil and Amgen agree to co-sell PCSK9 inhibitor Repatha
- by Nho, Byung Chul Jun 10, 2022 05:42am
- Noh Sang-kyung, CEO of Amgen Korea (left), and Sung Seok-je, CEO of Jeil (right), pose after signing a joint sales contract for Repatha.Jeil Pharmaceutical (CEO Seong Seok-je) and Amgen Korea (CEO Noh Sang-kyung) announced on the 7th that they signed a joint sales contract for Repatha for patients with atherosclerosis cardiovascular disease and hypercholesterolemia as of the 1st of this month. With this joint sales contract, Jeil Pharmaceutical and Amgen Korea will conduct Repatha's sales and marketing activities at hospitals, and Jeil Pharmaceutical will be in charge of sales and marketing activities for clinics. Through Repatha's joint sales cooperation, the two companies expected synergy to provide improved treatment benefits for patients with ultra-high-risk cardiovascular systems in Korea and strengthen market competitiveness. Repatha is a PCSK9 inhibitor that lowers the reuse rate of LDL-C receptors by inhibiting the activity of PCSK9 proteins that decompose LDL cholesterol (hereinafter referred to as 'LDL-C') receptors, and obtained domestic approval in April 2017 and further adaptation to treatment of ▲ atherosclerosis in August 2018, and ▲ primary hypercholesterolemia and mixed dyslipidemia In particular, Repatha showed superior LDL-C drop effects and cardiovascular risk reduction effects in patients with atherosclerosis cardiovascular disease in a large-scale three-phase global clinical trial. In addition, a 5-year follow-up study, the longest among PCSK9 inhibitors, confirmed that the consistent LDL-C drop effect of Repatha treatment was maintained in long-term treatment. Meanwhile, ESC/EAS revised the guidelines and recommended that LDL-C targets for preventing recurrence of cardiovascular events in ultra-high risk groups of cardiovascular disease be less than 55 mg/dL, and more than 50% of the base level. CEO Sung Seok-je said, "We expect that this joint sales contract will create synergy with Amgen's innovative product/clinical data and will try to provide Repatha's clinical benefits to more cardiovascular patients." He also said, "We look forward to continuously expanding and developing cooperative relations with Amgen Korea through this contract." "Repatha is a representative product of Amgen's cardiovascular disease treatment, and based on innovative mechanisms, it provides new treatment opportunities for patients who had limitations in reducing cardiovascular risk with only existing treatment options," said Noh Sang-kyung, CEO of Amgen Korea. He said, "I hope that this joint sales contract with Jeil will deliver the clinical benefits of Repatha to more ASCVD patients and medical staff in Korea, which will serve as an opportunity for Repatha to firmly settle into a new treatment standard."
- Company
- Genomictree's colorectal cancer business is booming
- by Lee, Seok-Jun Jun 09, 2022 06:23am
- FS Research highly evaluated Genomictree's growth potential in a report on the 8th. Genomictree is a company that discovers biomarkers, verifies clinical efficacy, and develops and sells early diagnosis products for various cancers (colonial cancer, lung cancer, bladder cancer, etc.). According to the report, sales of Genomictree's colorectal cancer diagnostic kits are soaring in Korea. Sales of colon cancer diagnostic kits, which recorded 300 million won last year, are estimated to be about 900 million won in the first half of this year, with 3 billion won annually. Hwang Se-hwan, a researcher at FS Research, said, "Genomictree's diagnostic kit is much simpler than colonoscopy because it can diagnose colon cancer with just 1 to 2g of feces. The sensitivity and specificity are 90%, which is significantly higher than the fractional occlusion test. This advantage is that the number of hospitals in sales and supply has increased rapidly since this year," he analyzed. Researcher Hwang said, "Assuming that 11.5 million people aged 35 to 49 undergo colonoscopy once every five years, the number of people subject to colonoscopy is estimated to be about 2 million per year. Due to the large size of potential customers, the domestic market alone has very high growth potential," he predicted. He also mentioned the possibility of expanding global businesses. Genomictree began selling in Southeast Asia and Europe this year, and the U.S. and China are undergoing clinical trials. The U.S. is conducting exploratory clinical trials (1st), and plans to conduct confirmatory clinical trials (2nd) next year and release them in 2024. Researcher Hwang said, "Competitor Exact Sciences, which has a market capitalization of 10 trillion won, has grown 30% by achieving 2.21 million inspections in 2021, seven years after its launch. Genomictree has a similar level of sensitivity and specificity to that of Exact Sciences. It is expected that it will expand its market share in the U.S. with advantages such as low inspection costs, short inspection time, and very small amount of stool inspection." The surge in domestic sales of colorectal cancer diagnostic equipment is evidence that the possibility of success in the global market is increasing. We should pay attention to Genomictree as these expectations can be reflected in the stock price, he added.
- Company
- Impurity data on schizophrenia and asthma drugs submitted
- by Chon, Seung-Hyun Jun 08, 2022 05:56am
- Pharmaceutical companies are submitting results of their impurity inspections on the schizophrenia treatment ‘Quetiapine’ and asthma and allergic rhinitis treatment ‘Montelukast’ one after another. As of now, no product has been recalled due to excessive impurities, and the health authorities plan to take follow-up measures after reviewing the drug companies' impurity inspection data. According to industry sources on the 7th, pharmaceutical companies submitted data on their schizophrenia treatment ‘Quetiapine’ to the Ministry of Food and Safety by May 27th. The data contained the companies’ evaluation of the possibility N-Nitroso-Aryl Piperazine (NNAP) impurities, process safety review data, provisional management standards, and grounds for setting such standards. This is a follow-up measure made after the MFDS requested the companies to submit impurity data on drugs that contain quetiapine in late April. The MFDS ordered companies to submit test results on the companies’ representative batch numbers among finished quetiapine products that can be sold in the market by July 28th. A representative batch number refers to three or more batches that are nearing expiry every year. Products manufactured in 3 batches or less are required to submit test results of all batches. This precautionary measure was made according to the safety information that NNAP impurity was detected in a single-agent quetiapine product. The MFDS had ordered pharmaceutical companies to submit data including those evaluating the possibility of NNAP impurities in quetiapine products by May 27th. NNAP is a new nitrosamine impurity that has been identified in the market. .Since 2018, two types of nitrosamine impurities, - ‘N-nitrosodimethylamine (NDMA)’ and ‘N-nitrosodiethylamine (NDEA)’ were detected in valsartan, ranitidine, and nizatidine .Quetiapine is a generic used to treat schizophrenia .Its original is Alvogen Korea’s ‘Seroquel.’ Around 30 Korean companies are currently selling quetiapine generics, and the domestic market grosses ₩30 billion a year .No quetiapine product in the market has been detected to have excess impurities in Korea yet, but it is impossible to rule out the possibility that some products with excess impurities may be found in the tests of finished quetiapine products .Based on the submitted data, the MFDS plans to closely review the impurity risk of quetiapine products in Korea .An MFDS official said, “We plan to make follow-up measures after the test results are submitted and a comprehensive review of all the results are made.” None of the montelukast products, on which the impurity issue had arisen earlier this year, have been recalled either .The Ministry of Food and Drug Safety had previously ordered pharmaceutical companies to investigate their montelukast ingredient and finished products for impurities and submit the reports by April 25th .This precautionary measure was issued after the ministry received safety information that N- nitrosodipropylamine (NDPA) was detected in the API montelukast .Manufacturers and importers of montelukast were then required to submit test results on representative batch numbers that can be distributed in the market .The MFDS asked the companies to conduct additional follow-up measures if necessary .Manufacturers and importers of finished products are required to conduct evaluations on the possibility of impurities in the manufacturing process .If necessary, the companies are also required to conduct tests and follow-up measures like the API companies .The MFDS ordered companies that produce raw materials and finished products to immediately report NDPA impurities found during inspection even before the submission deadline .Montelukast is used to treat allergic rhinitis and asthma .The original drug is Organon Korea’s ‘Singulair.’ In Korea101 domestic pharmaceutical companies are selling generic versions with the same ingredient .Its domestic market grosses around ₩100 billion a year .The pharmaceutical companies had submitted impurity inspection results on montelukast products by April according to MFDS instructions, and no impurity issue has been identified in the products sold in Korea as of now .In April, Organon Korea had announced that no impurities were detected in ‘montelukast sodium,’ the active ingredient of its allergic rhinitis and asthma treatment ‘Singulair.’ An MFDS official said, “We are currently reviewing impurity review data on montelukast, and will take the necessary safety measures according to the plan we have previously prepared.”
- Company
- Avodart leads 6th quarter
- by Kim, Jin-Gu Jun 08, 2022 05:56am
- Dutasteride are strong in the domestic hair loss treatment market. Both original and generic recorded higher sales growth than competitive drug Finasteride. According to IQVIA, a pharmaceutical market research firm, on the 2nd, GSK Avodart's sales in the first quarter were 10.7 billion won, up 9% from 9.9 billion won in the first quarter of last year. During the same period, Sales of Propecia fell 2% from 9.8 billion won to 9.7 billion won. The gap between Avodart and Propecia is 1.05 billion won, the largest since the second quarter of last year. Avodart, which was used as a treatment for prostate hypertrophy, has been in the shadow of Propecia for more than a decade since it began to be prescribed as a treatment for hair loss, adding indications in 2009. However, it has been maintaining its No. 1 position in the market for six consecutive quarters since it surpassed Propecia by a narrow margin in the fourth quarter of 2020. Quarterly sales of Propecia & Avodart ( Unit: 10 million won Data: IQVIA) In the case of generic, it was found that products with Dutasteride grew more than those of Finasteride. Total sales of Avodart's generics in the first quarter was 7.5 billion won, up 22% from 6.1 billion won in the first quarter of last year. During the same period, Propecia's generics increased only 9% from 12.3 billion won to 13.5 billion won. Sales of major generic products also reflected this trend Among generics for Propecia, sales of the u pharmaceutical's Momopecia increased 7% from 1.4 billion won to 1.6 billion won in a year, while JW's Monda and Genuonesciences's Mypecia fell 19% and 18%, respectively. In the case of generics for Avodart, Sales of Hanall Biopharma's Adamo tripled from 200 million won to 600 million won in a year. The pharmaceutical industry points to price competitiveness as one of the reasons for the increase or decrease in sales of major products. Recently, price competition has been fierce in the hair loss treatment market. Looking at the price supplied to the drugstore's online mall, the original product Propecia costs around 1,590 won. When THE U released Momopecia in 2020, it put a price tag of 600 won per tablet, which is less than half of the original. Momopecia has quickly grown into the highest-selling product among Propecia products with price competitiveness. As Momopecia grew rapidly, lower-priced products also appeared. In the second half of last year, DNBIO set a price of 350 won per 1mg dose t when it released Finaon. Other generic companies are said to have lowered prices one after another. As low-priced products grew around Momopecia, sales of existing high-end generic products such as Original Propecia and Monad (1,320 won) and Mypecia (960 won) naturally decreased. It is explained that Sales growth of Avodart is also related to price. Avodart is currently supplying 0.5mg dose at around 700 won. As the patent expired in 2016, Avodart lowered the existing drug price from 1,300 won to 920 won. In 2017, it was further reduced to 700 won, adding half the price tag compared to Propecia.
- Company
- Sales of Nexavar fell sharply
- by Jun 08, 2022 05:55am
- Sales of Nexavar, which has dominated the primary treatment market for liver cancer for 10 years, are falling. This is because prices have fallen due to the release of generic products, and the status of the first treatment for liver cancer as a new drug has been shaken. Compared to two years ago, quarterly sales have halved. ◆Tecentriq with Lenvima 1Q Sales Half According to IQVIA, a pharmaceutical research agency, on the 30th, Lenvima recorded 2 billion won in sales in the first quarter. The figure is down 41.2% from 3.4 billion won a year earlier. Nexavar's sales have been falling for seven consecutive quarters since the second quarter of 2020. Compared to two years ago, quarterly sales fell more than half from 5.1 billion won to 2 billion won. With the advent of competitive drugs, sales of Nexavar began to decline. It is Lenvima, a new drug for liver cancer treatment that appeared in 10 years. Lenvima, which is used as the first treatment for liver cancer along with Nexavar, narrowed the gap with Nexavar and succeeded in reversing the first quarter of 2021. Lenvima posted 4 billion won in sales in the last quarter, up 17.6% from the same period last year. Nexavar is the first targeted treatment to appear in the market for liver cancer treatments that are difficult to develop. It has been firmly established as the only liver cancer treatment for more than a decade. Annual sales amounted to 26 billion won. Nexavar began to falter with the launch of Lenvima. Initially, sales of Nexavar were overwhelming due to the strength of sequential treatment leading to Nexavar-Stivarga. However, Lenvima slowly boosted its influence with improved data. In October 2019, benefits were applied as the first treatment and settled in the 3 billion won in quarterly sales. ◆ Competitive drugs are emerging one after another Recently, the decline in Nexavar sales has become steeper with the emergence of generics. The government cut Nexavar's insurance cap by 30% in February last year. The move comes after Hanmi Pharmaceutical, which overcame Nexavar's patent, launched generics. Accordingly, the upper limit of Nexavar insurance fell from 18,560 won to 12,992 won. Nexavar Immediately after the weak cut was applied, quarterly sales of Nexavar fell 32% from the previous quarter, and were affected by the cut. Since then, Nexavar has continued its quarterly sales of 2 billion won. generic for Nexavar, released by Hanmi Pharmaceutical, posted sales of more than 400 million won in the first quarter, the fifth quarter of its release. Recently, as a new primary benefit option, it is a combination of Tecentriq, an immuno-cancer drug with a completely different mechanism from Nexava, and Avastin, an anti-VEGF treatment. Tecentriq+ Avastin combination therapy predicted a sensation from the first data release. This is because the reaction rate was more than twice that of Nexavar, and the significantly improved OS and PFS were recorded. Tecentriq combined therapy has already begun to exert influence by expanding its indications as the first treatment for hepatocellular carcinoma in July 2020. Starting this month, the impact is expected to increase further as benefits will be applied to the first treatment. Although there are still no drugs that can be used after Tecentriq therapy, it is predicted that the paradigm of primary treatment, which mainly used Nexavar or Lenvima, will change to Tecentriq therapy.
- Company
- Neutropenia drugs' sales affected by their sales partners
- by Chon, Seung-Hyun Jun 07, 2022 06:04am
- GC Pharma and Kyowa Kirin are fiercely competing for the lead in the neutropenia treatment market in Korea. At the end of last year, GC Pharma’s Neulapeg had risen to the lead for the first time in 7 years, but Kyowa Kirin has again taken over the lead with Neulasta. The addition of Boryung’s sales power to the products is affecting the sales rank of the two drugs in Korea. According to the pharmaceutical market research institution IQVIQ, Neulasta sold the most and raised ₩6.5 billion in sales in the neutropenia treatment market in Q1 this year. Rising 4.9% YoY, Neulasta took back the lead that it had lost to Neulapeg in Q4 last year. Neutropenia treatments prevent cancer patients from developing the side effect of a weakened immune system due to decreased neutrophil levels when they receive anticancer therapies. Neutrophils are a type of white blood cell that fight infections from bacteria, etc. Neulasta, a pegfilgrastim ingredient drug that was approved in 2012 in Korea is a second-generation neutropenia treatment. Neulapeg’s rising sales have been challenging the lead held by Neulasta in the neutropenia treatment market. Neulapeg is a neutropenia treatment made with pegteograstim and is indicated for ‘the reduction of the duration of neutropenia in patients treated to eliminate solid tumor and malignant lymphoma with cytotoxic chemotherapy.’ Neulapeg is the first biologic anticancer therapy that was developed with GC Pharma’s original technology Neulapeg had little commercial success in the early days of its release. Sales in 2017 and 2018 were only ₩3.2 billion and ₩4 billion, respectively. Most of its quarterly sales had been less than ₩1 billion. However, its sales started to rise steeply with the addition of Boryung’s sales power GC Pharma had signed a joint sales agreement with Boryung in October 2018 to expand the share of Neulapeg by using the sales power held by Boryung Pharmaceutical in the field of anticancer drugs. In Q1 2019, immediately after Boryung’s addition, Neulapeg accumulated sales of ₩1.3 billion and made a new quarterly sales record. Since then, the drug has continued on its rise to record ₩6.3 billion in sales in Q4 last year. Sales had increased sevenfold in only 3 years from the ₩0.9 billion in Q3 2018 before Boryung’s addition to take over the lead product in the market. This change in market demographics is analyzed to be greatly influenced by the switching of sales partners of Neulasta and Neulapeg recently. Boryung, which had driven the rapid growth of Neulapeg, has been selling Neulasta from the start of this year. Boryung had contributed to Neulapeg’s rise to the top at the end of last year, and to Neulasta’s takeover of the lead again this year. In place of Boryung, Jeil Pharmaceutical has been selling Neulapeg as GC Cross’s partner. The company has experience selling Neulasta from 2014 to 2017.
