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- 2026-04-12 02:53:20
- Company
- Yuhan Corporation records new quarterly sales
- by Chon, Seung-Hyun Aug 01, 2022 09:14pm
- Yuhan set a new quarterly sales record. In the domestic market, both Rx and OTC drugs were strong, and overseas businesses were also doing well. Operating profit fell due to a decrease in technology fee revenue and an increase in R&D investment. Yuhan Corporation announced on the 28th that its operating profit based on separate financial statements in the second quarter fell 61.9% year-on-year to 10.8 billion won. Sales increased 10.4% year-on-year to 468 billion won. The company's second-quarter sales are the largest ever. It broke 439.4 billion won in the fourth quarter of 2020 for the first time in six quarters. Both domestic demand and overseas business showed growth. In the domestic market, sales of the OTC business were 49.1 billion won, up 23.9% from 39.7 billion won a year earlier. In the second quarter of last year, sales of Rx increased 8.9% year-on-year to 283.6 billion won. Sales of cold medicine Cough rose 154.2% to 7.3 billion won from 2.9 billion won in the second quarter of last year. Due to the spread of COVID-19, it has benefited from the increase in demand for cold medicines. Among the new drug products introduced by multinational pharmaceutical companies, sales of the diabetes treatment Jardiance rose 44.5% year-on-year to 20.5 billion won, and the hypertension treatment Twynsta rose 20.3% to 23.8 billion won. Vemlidy, a hepatitis B treatment, sold 11.6 billion won worth, up 38.4% from the previous year. Yuhan's overseas business sales amounted to 56.8 billion won in the second quarter, up 55.1% from 36.6 billion won in the same period last year. Yuhan buys raw materials produced by Yuhan Chemical and exports them to multinational pharmaceutical companies. Yuhan Corporation's technology fee revenue, which has emerged as a cash cow, has decreased. The company's second-quarter technology fee revenue was 5.2 billion won, down 69.0% from 16.7 billion won a year earlier. Starting with Spinebiopharma in 2018, Yuhan Corporation signed contracts to export new drug technologies with five global pharmaceutical companies, including Janssen Biotech, Gilead Bioscience, Beringer Ingelheim, and Processa Pharmaceutical. Except for Processa Pharmaceuticals, which paid the down payment in stocks, the down payment and milestones received from the remaining four companies are recognized in installments. Technology fee revenue is bound to show ups and downs due to the characteristics of new drug technology export contracts or technology transfer new drug development stages. Leclaza, which transferred technology to Janssen, made a total of $100 million in additional technology fee revenue before the development stage, but no large-scale technology fee revenue occurred this year.
- Opinion
- [Reporter’s View] MFDS minister wills regulatory innovation
- by Lee, Hye-Kyung Aug 01, 2022 05:58am
- The Ministry of Food and Drug Safety’s determination to seek regulatory innovation has surfaced with the inauguration of President Suk-Yeol Yoon’s administration. The MFDS had previously conducted 7 internal debates for each of its fields during the past 2 months to come up with a plan for ‘administrative innovation in food and drug at an international level', in line with the national goal of Yoon Suk-Yeol’s administration. In fact, regulatory innovation is the first assignment given to the MFDS by Yoo-Kyung Oh, the Minister of Food and Drug Safety that was appointed on May 27th. After holding internal debates and public forum for food and drug regulatory innovation on July 21st and 25th, respectively, the MFDS reported the administrative innovation measures for advancing into a global food and drug industry to become a core bio-digital healthcare country to the state affairs review and coordination meeting on July 28th. The MFDS plans to establish and present a ‘100 project roadmap’ to support its innovative measures on the 100th day of Yoon’s inauguration. Minister Oh’s determination for regulatory innovation was evident in the public debate. Oh sat through the public forum for food and drug regulatory innovation that had been conducted for 2 hours. Oh, who said she will humbly listen to the voices of the public rather than conduct a unilateral debate, closed the public forum saying that “We will make one step further from being an institution that answers questions asked by the public. We aim to enable a two-way communication where the MFDS also asks questions to the public for answers.” Also, the key Director Generals of bureaus that represent the drug area at MFDS appeared on the podium. An official from MFDS said, “During my over 20 years of service at MFDS, I have never seen a forum where 4 key Director Generals from major bureaus personally give presentations and answer questions.” This is because a comment made by MFDS Director Generals at such an event is like an oath made to the public. It needs to be kept, no matter what. Minister Oh’s determination had largely influenced the decision of MFDS Director Generals’ personal presentation of the regulatory innovative tasks under review. Oh is that much determined to achieve the national tasks set by the new government. Oh is expected to personally make the presentation on the 100 tasks that will be made in August. Industry expectations are also rising with the MFDS Minister’s personal interest in regulatory innovation. Among the various regulatory innovations planned, the Korea Pharmaceutical and Bio-Pharma Manufacturers Association expressed that it was pleased by the MFDS’s plan to provide global support and reinforce the fast track system. However, the ministry would need to pull through with its plan to the end. As much as the MFDS had endeavored to identify tasks for regulatory innovations, the ministry would need to keep its determination to implement regulatory innovation measures that can lead to changes in the actual field in 5 or 10 years.
- Policy
- MFDS Minister promises COVID-19 vaccineˑTx support
- by Lee, Hye-Kyung Aug 01, 2022 05:58am
- The Minister of Food and Drug Safety Yoo-Kyung Oh met with COVID-19 vaccine and treatment developers and relevant associations and promised support in the future. On the 29th, the MFDS held an MFDS-Industry roundtable meeting for the COVID-19 vaccine-treatment development support. The meeting was held to discuss the difficulties experienced by developers in conducting clinical trials and MFDS’s measures of support in situations where the development of a homegrown vaccine or treatment becomes imperative due to an epidemic. At the event, the MFDS introduced its measures for support in commercializing such products, listened to the difficulties that the industry experienced in the process of developing COVID-19 vaccines, and discussed measures of MFDS support for the development of vaccines and treatments. Minister Oh said, “Korea is an established leader in the pharma-bio sector that owns both a vaccine and treatment for COVID-19. The MFDS will continue to innovate regulations in the field to support the rapid commercialization of homegrown COVID-19 vaccines and treatments." Also, Oh mentioned that it has been linking development-non-clinical trials, clinical trials-approval & review processes while providing professional support on clinical trial design through the commercialization strategy support task force that had been established in April. Minister Oh said, “We plan to seek more efficient operation of the approval and review process for COVID-19 vaccines and treatments through rapid review, rolling review, etc. while thoroughly reviewing their efficacy and safety through close review and expert advice." Companies and related associations that participated in the meeting expressed their gratitude to the MFDS for enabling easier export of products upon domestic approval, which has advanced its regulations through safety-based regulatory innovation and commercialization support efforts and asked for the ministry’s continued support for rapid vaccine development against variants and clinical trial subject recruitment. The companies said, “It is imperative that the MFDS recruits more review personnel to enable rapid development of the second, third homegrown vaccines and treatments. We ask the MFDS to increase their review personnel and strengthen its expertise.” The MFDS expects the meeting to help identify various difficulties experienced in development and come up with support measures. The ministry added it will do its best to support the rapid development of domestic vaccines and treatments by operating programs specialized for COVID-19 and commercialization strategy support teams - such as ‘Our Vaccine Project’ and the ‘Development-focused support council’ - for the prompt development of homegrown vaccines and treatments.
- Company
- OAD drug Betmiga’s price halved with the entry of generics
- by Kim, Jin-Gu Jul 29, 2022 05:51am
- Prescription sales of Astella’s overactive bladder (OAD) treatment ‘Betmiga (mirabegron)’ halved in just one year. The analysis is that Betmiga’s sales took a direct blow from the launch of generics and the drug price cut that followed. Its generics, which had been released after Q2 in 2020, have been gradually increasing their influence in the market. In particular, with 17 more generic companies awaiting to join in the competition starting next month, sales of the original drug in the market are expected to continue to decrease. ◆ Betmiga’s price cut 47% …prescriptions performance also fell by half According to the market research institution UBIST on the 29th, the OAD treatment market size for mirabegron fell 34% in one year from ₩39.1 billion in 1H last year to ₩26 billion in 1H this year. The reduced prescriptions of the original drug Betmiga have played a key role in the market reduction. Betmiga’s prescription sales in 1H this year were ₩16.3 billion, a 50% YoY decrease from the ₩32.8 billion that was made in 1H last year. Until Q3 last year, Betmiga had made over ₩15 billion in quarterly sales every quarter. However, sales dropped to ₩12.8 billion in Q4 last year, then to ₩8.3 billion in Q1 and ₩8 billion in Q2 this year. Pic of the mirabegron original Betmiga (left) and generic Mirabek·Selebeta Analysts believe Betmiga’s price cut has directly affected the reduced prescription sales. Betmiga’s drug price had jumped up and down since the release of its generics in Q2 2020. Astellas had defended the 30% drug price cut disposition on Betmiga due to the release of its generics by filing administrative suits and suspension of disposition execution requests. During the first and second trials, the drug price was lowered and increased, and the execution was suspended and lifted repeatedly. In November last year, the government lowered the drug price through an ex officio adjustment following the lifted suspension of execution. In addition, Betmiga’s drug price had incurred more twists and turns with the PVA (Price-Volume Agreement) negotiation results being applied and lifted, a pricing premium being applied as a drug produced by less than 3 companies then again lifted with the entry of additional generics companies. As a result, Betmiga 50mg, which was priced at ₩673 until October last year, was discounted 47% to become ₩360 since January. The 25mg strength also fell 47% from ₩449 to ₩240. ◆17 more generic companies to enter in 2H…competition will intensify The industry prospect is that Betmiga’s prescription sales will continue to fall in 2H this year as many more generics will be entering the market following the expiry of the first generic exclusivity period. The first generic exclusivity period for Hanmi Pharmaceuticals’ Mirabek and Chong Kun Dang’s Selebeta expired in February this year. Hanmi and Chong Kun Dang successfully challenged Betmiga’s patent and consecutively released mirabegron generics in June and July of 2020. At the same time, the companies also achieved generic exclusivity and sold their generics exclusively on the market until February this year. Quarterly prescription sales of mirabegron original Betmiga and generic Mirabek·Selebeta (Unit ₩100 million, Data: UBIST) After the generic exclusivity period expired in February, 4 generic companies -Medica Korea, DongKoo Bio&Pharma, QL Pharma, and Genuone Science- joined in the competition 17 more companies will be joining the competition from next month. Il-Yang Pharmaceutical, Kyung Dong Pharm, Aju Pharm, The U Pharmaceuticals, Dongkwang Pharm, Ahngook Pharmaceutical, Boryung Pharmaceutical, Huons, Pharmbio Korea, Hutecs Korea Pharmaceutical, JW Pharmaceutical, JW Shinyak, Mother’s Pharmaceutical, Daewon Pharm, Samjin Pharmaceutical, Whan In Pharm Daewoong Bio, Dongkook Pharmaceutical among others announced they will be releasing 50mg mirabegron generics with reimbursement. In addition, Chong Kun Dang announced the plan to release a generic version of the 25mg strength that was exclusively sold by Astellas until now. Due to this, it is predicted that products that had been bringing in more than ₩60 billion a year until last year could sink to earn ₩30 billion a year. Among various Betmiga generics, Hanmi Pharmaceuticals’ Mirabek recorded the highest sales of ₩6.3billion in 1H this year. Chong Kun Dang’s Selebeta has made ₩2.6 billion in 1H this year.
- Policy
- MFDS announces a series of tasks for innovation
- by Lee, Hye-Kyung Jul 29, 2022 05:51am
- “If the 3 strategies set for the direction of the food and drug administration are the three mountains to conquest for the Ministry of Food and Drug Safety, the 100 National Tasks Roadmap that will be announced soon is like the 100 trees that we will be planting on the 3 mountains." Yu-Kyoung Oh, Minister of Food and Drug Safety, announced so at the ‘Briefing on the Standards for Globally Leading Innovative Food and Drug Administrative Measures ’ that was held at 1:30 p.m. on the 28th. After holding a public debate on regulatory innovation for the pharmaceutical sector on the 21st and the food sector on the 25th, the MFDS finally announced the measures for food and drug administrative innovation at the briefing. The 100 regulatory innovation tasks that will form the detailed tasks under the innovative measures, will be established and announced in line with the 100th day of President Suk-Yeol Yoon’s inauguration. The MFDS’ administrative measures for innovation will be to innovate its regulatory capabilities to a global level, support the global entry of new technologies with guaranteed safety, and enable the public to quickly enjoy the benefits of new technologies. Minister Oh said, “Global entry of drugs in the past had been difficult because the private companies had to seek their own paths of entry after the MFDS completes the approval process. As it is a regulated industry, each country has its own and diverse regulatory barriers." Therefore, the MFDS plans to analyze the global food and drug regulatory policies and operate a strategy task force to allow the industry to enter the global market after penetrating the regulatory barriers set for each country. Yoon-Joo Park, Director-General of the MFDS’s Drug Evaluation Department, said, “New product development has been increasing in the biohealth industry with scientific innovations like AIs as well as environmental changes. We will raise our regulatory capabilities so that passing the regulatory scientific standards set by the MFDS would mean that it could pass those set by global regulatory institutions.” Also, the operation of the three-tier system for regulatory relief that includes outside experts had been further explained at the briefing. (From the left) Yu-Kyoung Oh, Minister of Food and Drug Safety; Sang-Bae Han, Director General for Planning & Coordination; Oh-Sang Kwon, Director-General of the Food Safety Policy Bureau; Yoon-Joo Park, Director General of the Drug Evaluation Department; Sang-Bong Kim, Director General of Biopharmaceuticals and Herbal Medicine Bureau; Nam-Hee Lee, Director-General of the Medical Device Safety Bureau; Suk-Yeon Kang, Director-General of the Pharmaceutical Safety Bureau Sang-Bae Han, Director General for Planning & Coordination, said, “When a company requests regulation relief, the relevant departments first respond and make evaluations at the first tier. If the request is not accepted at in first tier, the company’s request goes on to the second tier and is applied the regulatory verification responsibility system.” The second tier mainly consists of civilian experts who will be determining whether the deregulation request should be accepted. Han said, “If the request is again not accepted at the second tier, we apply the last and final third tier, where the Minister of Food and Drug Safety directly checks the facts and seek for alternatives.” Regarding the ‘WHO Listed Authorities (WLA)’ that is being promoted, Minister Oh said, “The WHO has high regards for Korea’s regulatory capabilities and is reviewing Korea as the first candidate for WLA listing. We will be listed on the WLA at the end of this year at the earliest, and by next year at the latest. Suk-Yeon Kang, Director-General of the Pharmaceutical Safety Bureau, said, “We have started receiving the WLA review from March this year, and 56 countries are currently on the tentative list. Korea is also on the tentative list, but we are being reviewed as the first candidate as the WHO recommended that we receive evaluations as the most qualified country for listing.”
- Company
- Ildong Pharmaceutical operates about 20 R&D pipelines
- by Chon, Seung-Hyun Jul 29, 2022 05:51am
- Ildong Pharmaceutical is using an aggressive new drug development strategy, risking a deficit for seven consecutive quarters. Ildong Pharmaceutical is operating about 20 new drug pipelines, and five of them have entered the clinical stage. It is focusing on enhancing the performance and possibility of new drugs by establishing a cooperation system with R&D subsidiaries. According to IR data from Ildong Pharmaceutical on the 28th, the company has a total of 20 new drug pipelines at the group level. New drugs are being developed in areas such as metabolic diseases, NASH, COVID-19, ophthalmic diseases, neurological diseases, cardiovascular diseases, and cancer. Among them, five cases, including diabetes treatments, COVID-19 treatments, acute migraine treatments, and anticancer drugs, have entered the clinical stage. In the case of IDG16177, a new drug candidate for type 2 diabetes treatment, it entered phase 1 clinical trial in July last year after obtaining approval from a German pharmaceutical and medical device management institution. IDG16177 is a new drug candidate in the family of GPR40 agents with a mechanism to regulate blood sugar by activating GPR40 (G protein-binding receptor 40) in pancreatic beta cells, minimizing the risk of hypoglycemia due to drug administration Idience, a subsidiary of Ildong Holdings, is conducting a phase 2 clinical trial of the new anticancer drug candidate IDX-1197 that was handed over from Ildong Pharmaceutical. IDX-1197 is a target anticancer drug candidate that selectively acts on a deep poly ADP-ribose polymerase (PARP) enzyme related to cancer production to suppress cancer cells. It was developed by Ildong Pharmaceutical on its own and handed over the rights to . is a bio-venture founded by Ildong Holdings in May 2019. It advocates NRDO bioventures that are dedicated to development without discovering new drugs directly. In November last year, Ildong Pharmaceutical started clinical trials in Korea on Shionogi's oral COVID-19 treatment candidate "S-217622" and is currently undergoing phase 3 clinical trials. Reyvow, a migraine treatment that Ildong Pharmaceutical secured in Korea, was approved by the Ministry of Food and Drug Safety in May after a phase 3 clinical trial in Korea. Reyvow is the first migraine treatment to act as a serotonin (5-HT) 1F receptor. Ildong Pharmaceutical signed a development partnership with CoLucid in the U.S. in 2013 to secure domestic copyright. The new drug candidate for NASH treatment ID119031166 is being developed globally. ID119031166 is a NASH treatment with the FXRagonist mechanism that activates the receptor by combining it with farnesoid X receptor (FXR) and aims to enter phase 1 clinical trials overseas by the end of this year. Ildong Pharmaceutical predicted that the gastroesophageal reflux disease treatment ID120040002 and the dry eye disease treatment ID110410395 will enter clinical trials within this year. Ildong Pharmaceutical invested 34.1 billion won, the largest amount ever, in R&D expenses in the second quarter. 21.0% of sales were spent on R&D investment. It has tripled in two years from 11.6 billion won in the second quarter of 2020. During this period, Ildong Pharmaceutical invested 176 billion won in R&D. Ildong Pharmaceutical is also using a strategy to increase the efficiency and speed of new drug development by establishing a cooperative system with three unlisted bio-ventures such as Idience, AIMS BioScience, and iLeadBMS. iLeadBMS succeeded in attracting 40 billion won in investment last year. Last month, it received a total of 65 billion won since its launch, including investments from Ildong Holdings. The investment secured by iLeadBMS is expected to be used as a resource for developing new drugs. Ildong Holdings acquired AIMS BioScience, a new drug development strategy consulting firm, in December 2019. AIMS BioScience is responsible for providing advice on the development of new drugs to Ildong Pharmaceutical, Idience, and iLeadBMS. It is a method of providing consulting when new drug development companies request AIMS BioScience for strategic advice on providing development data. iLeadBMS, acquired by Ildong Pharmaceutical last year, plays another role in the development of new drugs in the group. Founded in December 2020, iLeadBMS is a bio-venture that develops new drugs in the field of low molecular compounds. It started as an in-house venture centered on Ildong Pharmaceutical researchers and launched an independent corporation in 2020. In July last year, Ildong Pharmaceutical invested 13 billion won in cash to secure a 40.0% stake in iLeadBMS by participating in a paid-in capital increase. iLeadBMS is developing new drugs using low molecular compound pharmaceutical chemistry in various fields such as glaucoma, liver cancer, non-alcoholic fatty liver, biliary disease, Parkinson's disease, glaucoma, breast cancer, Alzheimer's disease, Parkinson's disease, and metastatic breast cancer. Ildong Holdings is also planning a scenario to increase the success rate of new drug development by handing over the new drug candidate materials derived by iLeadBMS to Idience.
- Company
- Tax credit when acquiring an overseas vaccine company
- by Kim, Jin-Gu Jul 29, 2022 05:50am
- Starting next year, domestic companies that buy overseas vaccine technology companies are expected to be able to expect corporate tax deductions of up to 10% of the acquisition price. According to the pharmaceutical industry on the 27th, the Ministry of Strategy and Finance recently finalized and announced the "2022 Tax Reform Plan." The government plans to revise the Restriction of Special Taxation Act after collecting opinions based on the tax reform plan. The tax reform plan includes expanding the scope of tax exemptions following the acquisition of foreign corporations with high-tech technologies to national strategic technologies. Under the current Restriction on Special Taxation Act, tax deductions are granted only when domestic corporations acquire stocks and stakes of so-called small managers related foreign corporations such as materials, parts, and equipment or take over businesses and assets. The deduction rate is 5% for large companies, 7% for medium-sized companies, and 10% for small and medium-sized companies. The acquisition price for each acquisition is recognized up to 500 billion won. For example, if a domestic pharmaceutical company A acquired overseas vaccine technology bio-venture B for 500 billion won, large companies will deduct 25 billion won in corporate tax and 50 billion won in small and medium-sized companies. The government plans to expand the special taxation regulations from small department heads to 34 national strategic technology companies. Last year, the government designated 34 technologies in three major areas, including semiconductors, batteries, and vaccines, as national strategic technologies. Among them, vaccines include ▲ vaccines, raw materials, and raw material equipment development and manufacturing technologies, ▲ vaccine manufacturing technology with protective substances such as antigen, nucleic acid, and virus vector, ▲non-clinical testing technology that evaluates vaccine candidate substances with cell and animal models, ▲ phase 1, 2, and 3 clinical trials of vaccine candidate materials, and ▲development and manufacturing technology of raw materials, raw materials, and immunosupplement necessary for vaccine development and manufacture,
- Company
- 13 companies overcome key patents for Entresto
- by Kim, Jin-Gu Jul 29, 2022 05:50am
- Domestic pharmaceutical companies won the first trial of the patent dispute over Novartis' Entresto (Valsartan + Sacubitril). it is predicted that domestic pharmaceutical companies will soon launch generics for Entresto as they succeeded in targeting use patents that were considered key patents among Entresto patents. ◆ 13 domestic pharmaceutical companies succeeded in overcoming use patents that are key to Entresto According to the pharmaceutical industry on the 27th, the Korean Intellectual Property Tribunal recently ruled on the invalidation of Entresto filed by 13 pharmaceutical companies, including Hanmi Pharmaceutical, against Novartis. It is significant in that Korean companies succeeded in targeting usage patents, which were classified as key patents among Entresto's five patents (including one unregistered). Entresto is protected by a total of five layers of patents. ▲ a pharmaceutical patent that expires in November 2028, ▲ a pharmaceutical patent that expires in January 2029, ▲Salt and hydrate patents that expire in November 2026 (not registered), ▲Patents for use that expire in July 2027 and ▲Decisive patent expiring in September 2027. Entresto is a combination of Valsartan and Sacubitril, and there is no separate substance patent. Instead, the use patent actually serves as a material patent. ◆ Hanmi Pharmaceutical leads Entresto patent targeting Among many domestic pharmaceutical companies, Hanmi Pharmaceutical is the fastest target of Entresto patents. Except for one unregistered product, it overcame all four patents. In the case of pharmaceutical patents that expire in 2028, only Hanmi Pharmaceutical has been avoided. In the case of another pharmaceutical patent that expires in 2029, Hanmi Pharmaceutical and Daewoong Pharmaceutical succeeded in targeting it. In addition, Crystalline patents for Entresto were overcome by Hanmi Pharmaceutical, Elyson, Yoo Young, Hana, Hanlim, Ann-gook, Chong Kun Dang, Daewoong Pharmaceutical, Genuonescience, Samjin, Genupharma, CTC bio, and Yuyu. Hanmi Pharmaceutical succeeded in targeting all four patents registered with Entresto for the first time in Korean history, crossing all hurdles for the release of generics. Hanmi Pharmaceutical, which meets the requirements for generic for exclusivity, plans to release generic as soon as it obtains the license.
- Company
- Sanofi to increase supply volume of its flu vaccines in KOR
- by Jul 28, 2022 05:54am
- The competition in the flu (influenza) vaccine market is expected to intensify this year. With Sanofi succeeding in making the government bid at a cheaper price and expected to bring more supply into the private market, larger-than-expected quantities of the flu vaccine are expected to be released into the private market. According to industry sources on the 28th, the influenza vaccine amount for vaccinations will be lot released starting at the end of August. Compared to the previous year, when the vaccine return rate was high due to COVID-19, the demand for vaccinations is expected to increase this year. Influenza vaccine manufacturers are fiercely planning their strategies for the private market this year. This is because although SK Bioscience decided not to manufacture a flu vaccine this year as it did last year, Sanofi may enter as an unexpected contender. Sanofi, which had introduced a smaller amount of its flu vaccine than other Korean companies in Korea, started increasing its supply amount last year. This year, the company is known to have introduced more than it had done last year. Its participation in the influenza vaccine bid for senior flu vaccines under the National Immunization Program (NIP) in addition to the one made for the children’s NIP flu vaccine supply is one indicator of its increased supply in Korea. Sanofi had bid the lowest price of ₩10,433 for 2.2 million doses in the NIP bid for influence vaccines by the Korea Disease Control and Prevention Agency that was held in June. Sanofi, which was chosen No.1 for its lowest price, will be able to supply all of the 2.2 million doses it had written out. The second in line, Korea Vaccine, will supply 1.7 million doses at ₩10,670, followed by Boryung Biopharma supplying 1.8 million doses at ₩10,687. GC BioPharma and Il-Yang Pharmaceutical, which had written out the highest price, were tied at fourth place, among which GC BioPharma was selected first due to its larger amount supply. GC BioPharma, which had bid 6 million doses, will be supplying 4.96 million doses. Sanofi was able to increase its vaccine supply this year because of the influenza strains that were chosen for the northern and southern hemispheres this year. Every year, the World Health Organization announces the anticipated circulating strains in both the northern and southern hemispheres, and an unusual coincidence where the anticipated circulating strains in the southern hemisphere in 2021-2022 and those of the northern hemisphere in 2022-2023 were identical occurred this time. Therefore, Sanofi will be able to sell the amount that it was unable to sell in the southern hemisphere in the northern hemisphere this year. Therefore, the industry believes that more than the 2.2 million doses that were bid for NIP by Sanofi may be released into the private market this year. Also, the addition of Il-Yang Pharmaceutical’s 1.9 million doses that were not procured for the NIP will also be released into the private market. A vaccine industry official said, “The competition is expected to intensify further due to Sanofi’s success in making the NIP bid and the projection of its faster supply to the market this year. Also, the standard price for the vaccine bid next year will also be lowered due to Sanofi’s lowest price this year, deepening concerns of the vaccine companies.
- Company
- Samsung Biologics's 1H sales exceed ₩1 trillion...
- by Kim, Jin-Gu Jul 28, 2022 05:54am
- Samsung Biologics 1H sales exceeded ₩1 trillion for the first time since its establishment. The company attributed its improved results to the rapid growth of its CMO business, the increased capacity utilization rate of its 3rd plant, and the increased exchange rate. ◆"Lands 7 contracts in 1H… the company’s 1st, 2nd, and 3rd plant is operating at full capacity" On the 27th, Samsung Biologics publicly announced that it had recorded consolidated sales of ₩1.1627 trillion and an operating profit of ₩346.1 billion in the 1st half of this year. Excluding the performance of its subsidiary Samsung Bioepis, the non-consolidated, separate sales by Samsung Biologics itself exceeded ₩1 trillion to record 1.015 trillion. This is the first time the company exceeded ₩1 trillion in 1H sales since its establishment. In terms of 1H sales, the company has grown an average of 78.8% per year since 2019. Samsung Biologics explained that the increase in factory utilization rate and the exchange rate led to the expanded results. Samsung Biologics signed CMO deals for 7 products from 5 global pharmaceutical companies including Janssen, Merck, GSK, Lilly, and Novartis in 1H this year. As such, the cumulative number of CMO deals made by the company reached 73, amounting to $7.9 billion. With the added deals, all of Samsung Biologics’ plants(1st,2nd,3rd) are operating at full capacity. If the 4th plant, which has 256,000 liters of total manufacturing capacity, becomes complete, Samsung Biologics will account for 30% of the global biopharmaceutical CMO production capacity. An official from Samsung Biologics said, “On July 18th, Samsung Biologics signed a purchase agreement with the Incheon Free Economic Zone (IFEZ) to purchase an additional 350,000 square meters of land in Songdo, Incheon for the establishment of its 2nd Bio Campus. We are now ready to further solidify our status as a world-class global No.1 CDMO. ◆"Samsung Biologics fully acquires Samsung Bioepis …powered by robust global sales of biosimilars The incorporation of Samsung Bioepis into the company had also contributed to Samsung Biologics’ sales growth. In April, Samsung Biologics fully acquired the shares of Samsung Bioepis from Biogen for US $2.3 billion. With the acquisition, Samsung Bioepis has become a consolidated wholly owned subsidiary of Samsung Biologics. Samsung Bioepis’ results have been reflected through consolidated accounting in Samsung Biologics’ financial results from May. Samsung Bioepis’ 1H sales were ₩431.9 billion with an operating profit of ₩93.2 billion. In Q2, sales had increased 24.2% YoY to record ₩232.8 billion, and operating profit increased 95.7% YoY to record ₩58.5 billion. The company explained that its Q2 results improved due to an increase in the sale of its biosimilar products in the global market, including in the US and Europe. Samsung Bioepis has a total of 6 biosimilars commercially available in the market, and its revenue has steadily grown driven by increases in global product sales and milestone payments. SB4 (Enbrel biosimilar), its autoimmune disorder treatment that had been released in Europe in 2016, has surpassed its originator’s sales in Europe and overtook the majority of the market share. The company also released SB11, (Lucentis biosimilar) in June this year in the US. In addition to the 6 already commercialized products on market, 4 additional biosimilar candidates are currently in late-stage development in the company, most of which are nearing commercialization. The rare disease treatment SB12 (Soliris biosimilar) is under marketing authorization review, and the Phase III trial for the ophthalmologic disease treatment SB15 (Eylea biosimilar) is complete. Also, Phase III trials for SB16 (Prolia biosimilar) and SB17 (Stelara biosimilar) are currently underway.
