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- 2025-12-25 01:07:41
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- FDA grants ODD to LG Chem’s oral genetic obesity drug
- by Chon, Seung-Hyun Jun 20, 2022 06:03am
- LG Chem announced on the 16th that the US Food and Drug Administration has been additionally granted orphan drug status to its new genetic obesity drug ‘LB54640.’ The FDA has recently designated LB54640 as an orphan drug for the treatment of pro-opiomelanocortin (POMC) deficiency.’ The FDA has been operating an Orphan Drug Designation (ODD) system to encourage and support the development of treatments for rare and intractable diseases that affect less than 200,000 persons in the US. The number of POMC patients suffering from genetic obesity in the US is estimated to be around 120,000. With the designation, LG Chem will be receiving benefits such as 7-year marketing exclusivity in the US market, support for clinical trial costs, tax credit, and development-related pre-consultation support for the drugs’ development. LB54640 had formerly received FDA ODD as a treatment for ‘leptin receptor deficiency’ in September 2020. LB54640 is a targeted, once-daily oral treatment that targets the pathway of the MC4R (melanocortin 4 receptor) protein that is involved in appetite sensation. It induces appetite suppression by directly acting on the MC4R protein that delivers the final signal of fullness even if defects exist in its upper pathway genes (LEPR, POMC, etc.). LG Chem has recently completed a Phase I trial on LB54640 in healthy overweight adults without genetic defects and plans to announce its results within this year. Then, the company will be entering global Phase II/III trials on genetically obese patients with LEPR or POMC genetic deficiencies from next year. LG Chem said, “We plan to provide a differentiated treatment experience with our new oral drug through its improved convenience in the rare obesity treatment market that is currently occupied by injection-type formulations.
- Company
- GC Pharma leads 300 billion flu vaccine market
- by Nho, Byung Chul Jun 15, 2022 07:48pm
- SK Chemicals and GC Pharma are competing in the private 4-valent influenza (flu) vaccine market with an external banding of 200 billion won, the survey showed. SK Chemical's SKY Cellflu Quardrient and GC Flu Quardrient ranked first and second in the private distribution flu vaccine for the past three years (2018, 2019, 2020), with performances of "11.3 billion won, 13.1 billion won, and 63.8 billion won," "7.7 billion won, 12.4 billion won, and 51.5 billion won," respectively. However, in the case of last year, it is difficult to compare sales absolutely because SK Chemical placed seasonal flu production as a subordinate priority due to CMO issues of the COVID-19 vaccine. The growth of Boryung Biopharma FluV Tetra and Flu8 Tetra is also noteworthy. The total performance of the two products in 2018, 2019, 2020, and 2021 is 6.3 billion won, 7.1 billion won, 37.9 billion won, and 34.4 billion won, securing the third place. Ilyang's Teratect rose sharply from 970 million won in 2018 to 20.4 billion won in 2021, and the Korean vaccine Kovax flu quadrivalent also achieved a quantum jump in sales from 990 million won to 13.2 billion won during the same period. The overall performance increase of flu vaccine products can be attributed to temporary strategic production issues of SKY Cellflu quardrient, increased demand due to twin-demic concerns, and cold chain issues in 2020. Among foreign companies, Sanofi's Vaxigriptetra and GSK's Fluarix Tetra are supplied to the private sector. Vaxigcriptetra's sales were 4.4 billion won, 4.6 billion won, 12.7billion won, and 13 billion won while Fluarix Tetra's sales were 11.6 billion won, 7.8 billion won, 13.6 billion won, and 5.1 billion won. The size of the trivalent flu vaccine market has been reduced from 53.3 billion won in 2019 to 1.9 billion won in 2021. GC Pharma's trivalent flu vaccine GC Flu also posted sales of 12.4 billion won in 2018, but it has reduced its portion to 8 million won in 1Q in 2022 and is focusing its efforts on the quardrivalent vaccine. What should be noted is the opening of the quardrivalent vaccine era, and LG Chem has no sales of its only three-valent flu vaccine, Flu Plus TF. This product showed a performance of between 2 billion won and 5.6 billion won between 2018 and 2019, but it was the last time it sold 400 million won in 2020. In the bidding market for influenza vaccines between 2022 and 2023, Korea Vaccine and Boryung Biopharma, which bid 10,433 won(2.2 million doses), 10,670 won and 10,687 won respectively, will supply 1.7 million to 1.8 million doses to the KCDA. GC Pharma (6 million doses) and Ilyang Pharmaceutical (1.9 million doses) offered 10,700 won in the same bid. Ilyang Pharmaceutical fell from the KCDA's bid due to a bidding rule that selects companies with large quantities at the same price. Regarding the supply and demand of the flu vaccine in the open bidding market for the Nara Market of the Public Procurement Service, the KCDA amount is about 11 million doses, which is about 90 billion won in amount. The NIP market is formed in the range of 7,000 won to 10,000 won, which is lower than the private supply price, making it difficult for pharmaceutical companies to secure margins, raising public opinion on the realization of bidding prices. The flu vaccine vaccination price, which is supplied to the private sector, is around 20,000 won to 45,000 won, and the vaccination rate is increasing through various events. In the case of clinic A, it is promoting that the price has been reduced from 35,000 won to 27,000 won for a single vaccination of tetravalent influenza vaccine. The tetravalent influenza vaccine + shingles vaccine is discounted from 205,000 won to 180,000 won, and the tetravalent influenza vaccine + pneumococcal vaccine is discounted from 165,000 won to 140,000 won. Regarding the overall situation, Pharmaceutical B said, "It is also unusual that some companies are not very interested in NIP open competitive bidding due to the mismatch of realistic procurement prices in the vaccine bidding market." An employee of this pharmaceutical company said, "We are focusing our production and marketing capabilities on private supplies with a relatively high margin." The procurement agency's bidding has been held by wholesalers, a distributor, but it has been directly participating in the manufacturing and import mission since last year due to the issue of exposure to room temperature of the flu vaccine in 2020.
- Company
- Samsung Bioepis Announces Phase 3 Results of Soliris Similar
- by Kim, Jin-Gu Jun 15, 2022 05:50am
- Samsung Bioepis announced on the 13th that it has unveiled the results of phase 3 clinical trials of Soliris (Eculizumab) biosimilar SB12 through the EHA annual academic conference held in Austria from the 9th to the 12th. SB12 is the seventh biosimilar developed by Samsung Bioepis. It is the first blood disease treatment. The original Soliris is a treatment for incurable rare diseases such as PNH and aHUS developed by Alexion in the U.S. Last year, global sales amounted to $1.874 billion (approximately 2.3 trillion won). Samsung Bioepis conducted a comparative study between SB12 and the original (ECU) in PNH patients from July 2019 to October 2021. At this conference, the results were announced in the form of an e-poster. Samsung Bioepis conducted clinical trials by comparing and evaluating efficacy, safety, pharmacology, and immunogenicity between the two products. Among PNH patients who were first prescribed drugs, 50 patients aged 18 or older whose LDH level was measured to be 1.5 times or more of the normal ULN were randomly assigned. Samsung Bioepis administered SB12 or original every week for the first four weeks, 900 mg at the fifth week, and 900 mg every two weeks during the subsequent maintenance period. It then conducted research until 50 weeks while switching the two products at the 26th week. The primary efficacy evaluation index for this clinical trial was set as the "LDH level at the 26th week of drug administration" and the "AUEC (Area Under Effect Curve) of the time-adjusted LDH from 14th to 26th weeks and 40th to 52nd weeks. As a result of the study, 46 out of 50 patients completed clinical trials, and the primary efficacy evaluation index met the predefined clinical equivalence range. The difference in mean LDH values at week 26 (SB12-ECU=34.48) between SB12 and the original drug was found to have a 95% confidence interval (-47.66, 116.62) in the predefined equivalence range. For SB12/ECU: 1.08) between SB12 and the original drug, it was included in the predefined equivalence range in the 90% confidence interval (0.95, 1.23). Similar results were found in the LDH values for the entire clinical trial period, one of the secondary efficacy evaluation indicators. For TEAs, SB12 was 72.3% and original drugs were 68.1%. All three serious post-treatment adverse events in SB12 prescribed patients were unrelated to treatment. Oh Yoon-seok, executive director of PE (Product Evaluation), the clinical director of Samsung Bioepis, said, "SB12 is a product that has the essential meaning of biosimilar development to improve patient accessibility of ultra-high-priced bio-medicine." He said, "We confirmed safety and efficacy compared to original drugs through clinical trials." Soliris is an expensive biopharmaceutical that costs hundreds of millions of won a year for adult-based medication, and Samsung Bioepis provides SB12 free of charge for up to two years to domestic and foreign patients who participate in clinical trials.
- Company
- Sales of topical minoxidil rise with interest in hair loss
- by Jun 14, 2022 06:04am
- (From the left) Rogaine, Mynoxyl, Dongsung Minoxidil The market for minoxidil topical solutions that are applied directly to the scalp continued on its strong growth, with marked growth shown by the foam-type Rogaine Foam among the three major products in the market. According to the market research institution IQVIA on the 14th, the minoxidil topical solution market had raised ₩4.6 billion in 4 months from January to April this year, a 36% YoY increase from the ₩3.4 billion made in the same period last year. The minoxidil market expanded rapidly with the rise in younger hair loss patients and the increasing perception that the condition needs to be managed in its early stages. Minoxidil, a topical medication that is directly applied to the scalp, expands the blood vessels to facilitate a smoother supply of nutrients to the hair. The market size, which had been below ₩1 billion from January to August last year, has increased to ₩1.5 billion this year along with the rising interest in hair loss. The total sales of minoxidil products in the market last year amounted to ₩12.5 billion, a 22% increase from the ₩10.2 billion of the previous year. Three products – Hyundai Pharm’s Minoxyl., Johnson&Johnson’s Rogaine Foam, and Dongsung Minoxidil – are leading the minoxidil topical solutions market. Among the three drugs, Hyundai Pharm’s Minoxyl has a 33% share of the market, followed by Dongsung Minoxidil (25%), then Rogaine Foam(24%). Recently, Rogaine Foam has been making the most marked growth. Rogaine Foam, which was released in 2017, has only accounted for 15% of the total market, bringing in an annual sales of ₩1.6 billion in 2020. However, its sales rose 89% last year to record ₩3 billion. Its market share had also grown 9%p to reach 24%. After chasing the runner-up Dongsung Minoxidil to the brim last year, Rogaine Foam beat Dongsung Minoxidil this year and took second place in the market. Its cumulative sales by April this year were ₩1.4 billion, a 119% increase YoY. Rogaine Foam’s market share had even exceeded that of the market leader Minoxyl in April this year. Rogaine Foam currently occupies 30% of the market, just a 1%p difference from the No.1 leader Minoxyl. This year’s market growth is analyzed to have been driven by Rogaine Foam. Sales of Minoxyl and Dongsung Minoxidil have also increased, but only by 18% and 12% each. By April, cumulative sales made by Minoxyl amounted to ₩1.4 billion, and Dongsung Minoxidil to ₩1 billion. Rogaine Foam’s contribution to the growth of the minoxidil topical solution market was 61% this year. It is interpreted that Rogaine’s foam type made this success by differentiating itself from the existing liquid-type products. As Korea’s first foam-type hair loss treatment, it minimized the dripping and stickiness associated with the gel-type formulation. Also, it does not contain propylene glycol (PG), which can cause skin irritation such as itching and stinging. In fact, a consumer survey on hair loss patients that was conducted by Johnson&Johnson shows that people who purchased Rogaine Foam selected its convenience in use and verified effect as the product’s top strengths. Also, the company believes its marketing campaign that related well to the minds of its consumers had brought a synergistic effect along with its product power. Junghwa Cha, brand manager at Johnson & Johnson Korea, said, “Our original foam type minoxidil topical solution shows the optimal effect when used in combination with oral finasteride, and is therefore commonly prescribed by specialists at hair loss clinics. Our efforts to highlight the product’s efficacy and effect while preparing a solid ecosystem so that consumers can appreciate the value of Rogaine Foam from every aspect, in addition to the support shown by pharmacists in the field, have driven the rapid growth of the product this year."
- Company
- Lilly Korea has entered into negotiations on Emgality
- by Eo, Yun-Ho Jun 14, 2022 06:04am
- CGRP target migraine drug Emgality is in the final stage for insurance benefit registration. According to related industries, Emgality, a target migraine treatment for CGRP (Calcitoninogen-related peptide) by Lilly Korea, recently began negotiations with the NHIS on drug prices. Considering the deadline for negotiations, a conclusion is expected within next month. If Emgality is reimbursed, it will be the first new drug in the system. Emgality passed the Drug Reimbursment Evaluation Committee on the 12th of last month after submitting a benefit application in March 2021. Handok Teva's Ajovy, which is currently a competitive drug, is also in the process of registration. These drugs are humanized monoclonal antibody drugs that bind to CGRP molecules that play a major role in causing migraine symptoms to block binding to receptors. Although the two drugs are of the same series, there are differences in doses, so patients with severe migraine are approaching with another expectation. Emgality was based on the EVOLVE-1 and EVOLVE-2 studies in which 1773 Episodic Migrain patients (4-14 days per month) participated for 6 months, and the REGAIN study in which 1,113 patients (15 days per month) participated in the average headache and 8 days or more. In particular, in the EVOLVE-2 clinical study involving Koreans, the average number of days of migraines per month for six months in the Emgality group (226 patients) decreased by two more days compared to the placebo group (450 patients) (4.3 days in the Emgality group and 2.3 days in the placebo group), the number of patients administered by Emgality, whose number of migraine days decreased by 50% over 6 months, was 59% (36% in the placebo group), 34% (18% in the placebo group) which decreased by more than 75%, and patients who decreased by 100% were 12% (6% of placebo group). Min Ju-kyung, a neurology professor at Sinchon Severance Hospital, said, "Migrain headaches are more painful than imagined and hinder the quality of life of patients. Patients who experience migraines more than 4 to 5 days a month can expect to improve their quality of life through preventive treatment," she explained.
- Company
- Whether Gardasil 9's supply price increase is reasonable
- by Jun 14, 2022 06:04am
- In order to improve the accessibility of vaccines monopolized by foreign companies, it was suggested that reasonable pricing should be monitored and institutional support measures for self-reliance should be actively reviewed. The Korea Biotechnology Industry Organization Bioeconomic Research Center said in a report titled "Controversy over domestic drug price hikes through cervical cancer vaccines" on the 13th, "Medicine prices should be reasonably priced in the drug market and should be monitored and improved if there is a competition restriction." The start is an increase in the supply of Gardasil 9, a cervical cancer vaccine for MSD. MSD raised its supply price by 25% in two years. Following the 15% increase in April last year, it decided to raise an additional 8.5 percent this year. It will be supplied at 132,636 won (excluding VAT) from July 1st. The Center for Biological Research questioned the additional increase in Gardasil 9 in MSD. "The price of drugs is set according to the logic of negotiation or free market competition with health authorities, reflecting the high failure rate, long development period, market size, and competition when developing new drugs. Excessive external intervention in the price of new drugs can hinder innovation. The center pointed out, "However, if the market dominance of certain drugs is large and the price continues to rise, the cause should be identified." In fact, Gardasil 9 accounts for 76% of the total market in the domestic cervical cancer vaccine market. There are only three types of cervical cancer vaccines: Gardasil, Gardasil 9, and Cervarix. All of them were developed by overseas pharmaceutical companies, and Gardasil 9, the latest of them, is dominating the market. Gardasil 9 prevents nine of the HPV serotypes that cause cervical cancer. The center then said, "Multinational pharmaceutical companies are emphasizing through ESG reports that they are working to expand access to medicines. MSD also said it has a role and responsibility to help improve access to medicines and vaccines around the world with the aim of sustainable development, pointing out that MSD's increase in supply of Gardasil 9 does not meet the company's goals. According to the MFDS, Gardasil 4 was also included in products that did not release generics even after patent rights expired among items with import performance of more than $10 million. The center stressed, "As the importance of health and security increases due to COVID-19, institutional support measures that can promote self-reliance in Korea should be actively reviewed if domestic development is sluggish."
- 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.
