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- 2025-12-24 21:46:20
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- LG Chem Applies to FDA for Phase 3 of Gout New Drug
- by jung, sae-im Aug 03, 2022 06:00am
- LG Chem announced on the 1st that it has applied for a phase 3 clinical trial plan for Tigulixostat, a new gout drug developed by the U.S. Food and Drug Administration (FDA). This is the first time that LG Chem has started phase 3 clinical trials of new drugs in global regions such as the U.S. The company's strategy is to significantly expand its bio business area centered on domestic demand and emerging markets to the U.S. and Europe. This clinical trial evaluates safety and effectiveness compared to placebo in 350 adult gout patients with hyperuricemia in multiple countries, including the United States, at the point of six months of taking Tigulixostat. The primary evaluation index was set as the proportion of patients who reached serum uric acid concentration of 6 mg/dL for 6 months. LG Chem will also apply to the FDA for a comparative test plan with Allopurinol, the primary treatment ingredient for gout patients with hyperuricemia. Its strategy is to prove differentiated efficacy and long-term use safety through recruiting large-scale global test groups. LG Chem aims to sell globally from 2028 after obtaining approval for item approval as a first treatment from the U.S. FDA in 2027. Tigulixostat inhibits the expression of the enzyme xanthine oxidease that produces uric acid, which is the main cause of gout. As a result of the U.S. Phase II results, Tigulixostat showed a rapid and strong uric acid drop effect, the company explained. According to the global market research firm CMI (Coherent Market Insights), the global gout treatment market is expected to expand from 3 trillion won in 2019 to 5 trillion won in 2027 due to aging population and increasing obese population. Currently, there are 35 million patients diagnosed with gout worldwide, of which the number of patients in the U.S. and China is estimated to be 10 million and 14 million, respectively. "Tigulixostat global phase 3 will be a solution to further strengthen LG Chem's new drug clinical, licensing, production, and sales capabilities," said Sohn Ji-woong, head of the Life Science Business Division. "We will lay a new turning point in the gout treatment market through clinical strategies and preemptive commercialization preparation."
- Company
- SK Bioscience has applied for CMA of SKY Covione
- by Kim, Jin-Gu Aug 02, 2022 06:02am
- SK Bioscience announced on the 29th that it has applied for Conditional Marketing Authorization (CMA) of the COVID-19 vaccine to MHRA, a British pharmaceutical regulator. The product name in the UK and Europe is SKY Covione. SK Bioscience explained that it has been conducting a Rolling Review since March to receive prompt approval from MHRA. Rolling Review is a system that quickly evaluates promising vaccines and treatments by submitting efficacy, safety, and quality data sequentially before applying for final permission. SK Bioscience submitted additional phase 3 clinical data recently secured to MHRA. MHRA will begin a full-fledged review for SKY Covione's CMA. Starting with the UK, SK Bioscience plans to apply for CMA to the European Medicines Agency (EMA) in the future and apply for registration on the World Health Organization's Emergency Use List (EUL). Ahn Jae-yong, president of SK Bioscience, said, "This application for permission will take the first step to introduce a domestic COVID-19 vaccine with excellent safety and immunity to the global big Pharma-centered COVID-19 vaccine market." Starting with the application for CMA in the UK, we will introduce Korea's technology to the global vaccine market through Europe and WHO EUL listing, he said. "In addition, it will contribute to restoring safe daily life through COVAX Facility." In June, SK Bioscience was approved for "SKY Covione multi injection" as the first domestic COVID-19 vaccine. SKY Covione is a COVID-19 vaccine developed by SK Bioscience based on its global network. It was jointly developed by IPD and SK Bioscience at the University of Washington, USA, and GSK's Adjuvant AS03 was applied to strengthen the immune response. It received development cost support from BMGF and CEPI from the early stage of development, and plans to be supplied to the global market through COVAX Facility after acquiring WHO EUL. SKY Covione demonstrated excellent immunogenicity and safety during basic vaccination through phase 3 clinical trials of 4,037 adults in five countries at home and abroad. Additional studies in phase 1/2 of the SKY Covione clinical trial showed a high immune response to the omicron mutation (BA.1). SK Bioscience is conducting clinical trials for ▲ heterogeneous booster shots and ▲ of the same kind of booster shot , and it plans to conduct ▲ an additional study to confirm the response effect of omicron mutations.
- Company
- Dong-A ST, applies for permission to Sugadapa
- by Kim, Jin-Gu Aug 02, 2022 06:01am
- Dong-A ST announced on the 29th that it has applied to the MFDS for the item license of type 2 diabetes complex Sugadapa. Sugadapa is a complex that combines Evogliptin 5mg, the main ingredient of the DPP-4 inhibitor-based diabetes drug Suganon, developed by Dong-A ST, and Dapagliflozin 10mg, the SGLT-2 inhibitor-based drug. DPP-4 inhibitors can control blood sugar without weight gain and hypoglycemic side effects. SGLT-2 inhibitors are known to reduce blood sugar while causing little hypoglycemia, reduce weight and blood pressure, and relieve heart failure. An official from Dong-A ST said, Sugadapa is expected to improve blood sugar control in diabetics and improve convenience and medication compliance, so we will lead the diabetes market with Sugadapa, which combines the advantages of Evogliptin and Dapagliflozin. Dong-A ST's Suganon was approved by the MFDS in 2015 as the 26th new drug in Korea. In 2016, it was approved for the approval of Sugamet, a combination of Suganon and Metformin. If Sugadapa is licensed, it will be the third drug in the Suganon series.
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- SK Bioscience applies for CMA of its COVID-19 vaccine to EMA
- by Chon, Seung-Hyun Aug 02, 2022 06:01am
- On the 1st, SK Bioscience announced that it has submitted an application for a Conditional Marketing Authorization (CMA) of its COVID-19 vaccine, ‘SKYCovion,' to the European Medicines Agency (EMA), SKYCovion is a COVID-19 vaccine that induces neutralizing antibody responses by administering an antibody protein made with SK Bioscience’s recombinant protein vaccine technology. SKYCovion was developed with SK Bioscience’s recombinant protein vaccine technology and the ‘self-assembly nanoparticle’ design technology of the Institute for Protein Design (IPD) at the University of Washington School of Medicine. From the initial stages of development, SKYCovion has been supported by funding from the Bill & Melinda Gates Foundation and Coalition for Epidemic Preparedness Innovations (CEPI). SKYCovion will be available through the COVAX Facility, etc. for procurement and equitable allocation worldwide after it is approved for Emergency Use Listing (EUL) by the World Health Organization (WHO). The company had previously applied for a Conditional Marketing Authorization (CMA) of SKYCovion to the UK Medicines and Healthcare Products Regulatory Authority (MHRA). Starting with the U.K. and European countries, the company plans to introduce this competitive domestic vaccine to the rapidly growing global COVID-19 vaccine market. According to Airfinity, a global healthcare market analysis institution, the global COVID-19 vaccine market size is estimated at around $65.6 billion (₩78 billion) last year, which is twofold the market size of all other vaccines (estimated at $33 billion). With the European Centre for Disease Prevention and Control (ECDC) and EMA that oversees the disease control and healthcare policy in the European Union lowering the vaccination age for the fourth dose from 80 to 60, the European market size for COVID-19 vaccines is expected to further increase. Jaeyong Ahn, CEO of SK bioscience, said, “The daily lives of people around the world are being threatened with the repeated emergence of new COVID-19 variants. We aspire to fulfill our role and responsibility as a global vaccine hub by entering overseas markets with our self-developed vaccine and developing new platforms to respond to the endemic."
- Company
- Daewoong Pharmaceutical's biggest quarterly performance ever
- by Kim, Jin-Gu Aug 01, 2022 09:16pm
- Daewoong Pharmaceutical achieved its highest quarterly performance ever. Separately, sales in the second quarter increased 7.6% year-on-year to 293.8 billion won and operating profit increased 25.8% to 33.6 billion won. Both sales and operating profit are all-time highs based on quarterly performance. Earlier, Daewoong Pharmaceutical also set the highest quarterly operating profit in the first quarter. It then broke its quarterly operating profit record once again for the first time in a quarter. Nabota enters the European market in the second half of the year Daewoong Pharmaceutical cited Nabota's propaganda as one of the reasons for achieving its biggest performance. According to the company, Nabota's second-quarter sales amounted to 37.1 billion won, up 60% from 23.2 billion won a year earlier. Nabota's exports grew 105% from 14.2 billion won to 29.2 billion won during the same period. U.S. exports account for the largest share of Navota exports. Exports to U.S. sales partner Evans doubled from the previous year to 21.1 billion won. Daewoong Pharmaceutical explained that exports to Southeast Asia and Central and South America were also strong. The recent rise in the exchange rate also contributed positively to the improvement of export performance. Sales in the specialized medicine sector rose 5.5% to 205.8 billion won from 5.1 billion won in the second quarter of last year. High-yield products such as hyperlipidemia treatment Crezet, diabetes treatment "Diabex" and antithrombotic Anplone increased by 10% compared to the same period last year. Sales of Forxiga, a diabetes treatment drug in charge of domestic distribution by Daewoong Pharmaceutical, also grew by more than 30% in a year, contributing to sales expansion. The OTC sector posted 34.3 billion won in sales, up 19.9% from 28.6 billion won in the second quarter of last year. Due to the spread of COVID-19, the fever reducer EZN6 grew 45% year-on-year. Ursa, a liver improvement functional drug, also grew by more than 30% during the same period. In the case of health functional foods, sales doubled in a year. Daewoong Pharmaceutical said it is expected to continue to increase profitability in the second half of this year. Nabota, which has become Daewoong Pharmaceutical's new cash cow, is set to be released in Europe, Turkey, and Chile after the third quarter. The addition of FexuClue, a new drug for gastroesophageal reflux disease released by Daewoong Pharmaceutical earlier this month, is also expected to increase its performance. Daewoong Pharmaceutical is moving quickly to expand FexuClue's market share. In Korea, the special features of FexuClue are actively informed to medical staff across the country through various channels. In the case of overseas markets, it has signed 1.1 trillion won worth of technology exports with 15 countries around the world, and plans to expand its export range sequentially to foster it as a global blockbuster new drug. An official from Daewoong Pharmaceutical said, "Nabota's expansion of its market share in major global botulinum toxin markets, including the United States, led to the highest quarterly sales and operating profit ever." He said, "We expect the company's growth and return to rise together when sales of FexuClue, a new drug for gastroesophageal reflux disease, are visible in the third quarter and Nabota is released in Europe and elsewhere."
- 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.
- 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.
- 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.
