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- 2026-03-16 23:45:11
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- 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.
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- 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,
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- 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.
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- 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.
- Company
- 5-year PDRN dispute comes to an end... PharmaResearch wins
- by Kim, Jin-Gu Jul 27, 2022 05:49am
- The long patent dispute between PharmaResearch and BMI Korea over the PDRN manufacturing method has finally come to an end, with the court ruling in favor of the original company, PharmaResearch. The industry expects the trial win to bring momentum to the rise of PDRN-based pharmaceuticals and devices, such as ‘Rejuran’ and ‘Conjuran.’ If the company also wins the patent infringement trial that follows, PharmaResearch will also be able to hold the generics in check, solidifying its position as the original product. ◆ Managing Director Kiseok Kang, “Court recognized our original technology" According to industry sources, the Patent Court of Korea ruled in favor of PharmaResearch in the reversed and remanded retrial on the PCRN manufacturing patent invalidation between PharmaResearch and BMI Korea on the 21st. This brought an end to the 5-year long legal dispute that started in 2017. In a phone interview with Dailpharm after the trial, Kiseok Kang, Managing Director of PharmaResearch, said, “After the long struggle, PharmaReserach was able to win the patent litigation and be recognized for our original technology. We plan to actively make this known to the market and solidify our position as an original product. He added, “With the final ruling made in the invalidation trial, the patent infringement suit that had been temporarily suspended due to the invalidation trial will be finalized soon. We are reviewing various strategies from multiple directions on how to proceed in the future.” The remark reflects Kang’s intent to hold generics in check through the patent infringement suit while strengthening the marketing and sales power of the original product while seeking new product development. ◆Twist after twist…PharmaResearch finally wins the patent invalidation trial after 5 years PharmaResearch had long been in a legal dispute over the patent for the PDRN manufacturing technology with BMI Korea. When BMI Korea received approval for ‘ HiDr injection,’ a same-ingredient latecomer drug in 2016, PharmaResearch pointed out that the drug’s API and manufacturing method were inappropriate. As a naturally-derived ingredient, PDRN has a more complex manufacturing method than chemical drugs. Therefore, PharmaResearch claimed that the difference in the origin of the raw material or manufacturing method can bring completely different efficacy and safety results, rendering BMI Korea’s drug completely different from its original. Also, the company claimed patent infringement, pointing out that optimizing DNA fragments extracted from fish for human use is PharmaResearch’s proprietary technology that requires demanding quality and manufacturing process control and management. PDRN patent invalidation trial progress BMI Korea confronted PharmaResearch’s claims with a patent invalidation trial. In January 2017, BMI Korea filed a trial against PharmaResearch to invalidate its PDRN manufacturing method. The legal battle that ensued showed reversal after reversal. PharmaResearch won the first trial with the Korean Intellectual Property Trial and Appeal Board rejecting BMI Korea's claim in January 2018. In January 2019, the Patent Court of Korea overturned the first trial's ruling. The court ruled that the PDRN patent was invalid. Once again, the victorious smile dawned on the other side at the Supreme Court. In January this year, two years after the hearing began, the court overturned the original ruling and decided to reverse and remand the trial. Following the decision, the Patent Court of Korea made the final ruling on the 21st of this month in favor of PharmaReserach. The 5-year long legal dispute has finally come to an end. With the win, PharmaReserach is expected to establish its own area in the market for PDRN-based pharmaceuticals and medical devices market. Currently, PDRN-based polydeoxyribonucleotide ingredient drugs come in two forms – pain treatment injections and eyedrops. 26 painkiller injections including PharmaReserach’s Placentex Inj and Rejuvenex Inj, and 10 eyedrops including the company’s Re-an Eye Drops are in competition in the market. PharmaReserach plans to actively use the court’s ruling to market its two market leaders. ◆Interest rises for the patent infringement suit…may halt the entry of generics depending on its results Results of the patent infringement suit that is being tried separately against BMI Korea are also gaining much attention. PharmaResearch, which owns the exclusive license for the PDRM manufacturing technology, had separately filed a ‘Damages Claim Based on a Patent Right Infringement (civil case)’ against BMI Korea in 2016, apart from the patent invalidation trial. However, the claim had been turned down by the Seoul Central District Court. Since then, the infringement suit had been temporarily suspended with the original suit continuing to the second and third trials. If PharmaResearch wins this case as well, sales of HiDr will be prohibited. From PharmaResearch’s view, this will allow the company to keep its biggest competition in check. PDRN is a pharmaceutical product extracted from the reproductive cells of salmon or trout and is used for skin regeneration, such as wound healing and tissue repair, etc. It selectively responds to act on damaged skin areas, reduce inflammation and regenerate tissue. The official name of the patent is ‘Polynucleotide fragments complex separated from fish's semen or egg and its manufacture. It is named ‘'DOT™(DNA Optimizing Technology).’ Its patentee is Mastelli in Italy, and PharmaResearch has the exclusive license for the patent in Korea. A product made from polydeoxyribonucleotide sodium, which is extracted from salmon semen, was first released in Korea through PharmaResearrch’s Placentex Inj that was approved in 2008. The company introduced the drug through a strategic partnership with Mastelli. PharmaResearrch, which had been importing and selling Placentex in Korea, set out to localize PDRN. Through joint research with KIST, the company developed a PDRN/PN extraction technology. Since it established the technology to extract-separate-refine the active material from salmon returning to the eastern coast of Korea in 2012, the company has been manufacturing its own PDRN ever since.
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- One-shot treatment Zolgensma lands in GHs with reimb
- by Eo, Yun-Ho Jul 26, 2022 06:05am
- # The ‘one-shot’ treatment Zolgensma may be prescribed with reimbursement at general hospitals in Korea. According to industry sources, Novartis Korea’s spinal muscular atrophy (SMA) treatment Zolgensma (onasemnogene abeparvovec) passed the drug committees of the Big 5 tertiary hospitals in Korea including the Samsung Medical Center, Seoul National University Hospital, and Seoul Asan Medical Center. Zolgensma will be listed for insurance benefits from August. With only its insurance-covered cost being ₩1.98 billion, the drug has been applied the Refund type, Expenditure Cap type, and Patient-unit performance-based type of the risk-sharing agreement (RSA) in its reimbursement. With the reimbursement already set, deliberations for reimbursed prescriptions will be made for patients, and patients who pass deliberations will be prescribed Zolgensma at medical institutions that have completed the landing process. The drug demonstrated its efficacy through the Phase III SPR1NT study and STRIVE-EU study. Results of the cohort of patients with 2 copies of SMN2 in the SPR1NT study showed that all pediatric patients who received presymptomatic treatment survived without respiratory or nutritional support, and achieved sitting alone for at least 30 seconds, and most (11/14) were within the normal developmental window as defined by the World Health Organization. In the STR1VE-EU study, the majority of the patients that received treatment with Zolgensma (82%) achieved developmental motor milestones that were not observed in the natural history of SMA Type 1, including patients with more severe disease. Meanwhile, Zolgensma is a gene therapy that contains a genetic material that functionally replaces defective genes. The Ministry of Food and Drug Safety approved Zolgensma as the second advanced biologic product after Kymriah. Advanced biopharmaceuticals are cell therapies or gene therapies that use live cells, tissues, or genetic material as ingredients. Under the ‘Safety and Support Act for Advanced Regenerative Medicine and Advanced Biopharmaceuticals,’ advanced biopharmaceuticals can receive differentiated safety management including long-term follow-up studies and support for R&D and product commercialization.
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- Daewoong to expand its diagnostic kit business globally
- by Nho, Byung Chul Jul 26, 2022 06:05am
- The number of new COVID-19 confirmed patients is increasing rapidly again. As of May this year, the number of confirmed patients in Korea has continued to decline, but it has rebounded since the record of 3,423 confirmed patients at the end of June, and the doubling of confirmed patients has continued for four weeks. In addition, face-to-face visits are restricted again in nursing hospitals and facilities. As COVID-19 enters a phase of re-proliferation, expert diagnostic kits are drawing attention again to determine whether COVID-19 is confirmed. Currently, there are a total of 32 antigen test kits for COVID-19 experts, including SD BioSensor, GenBody, SugenTech, and Calth, as of the 14th of this month. Among them, Calth, a startup specializing in in vitro diagnostic medical devices, has a contract with Daewoong Pharmaceutical to supply AllCheck COVID-19 Ag, Daewoong COVID-19 Ag. The Calth diagnostic kit supplied by Daewoong Pharmaceutical in Korea can be determined within 15 minutes by diagnosing the presence of viruses in the human nasopharynx and oropharynx using immunochromatography. Excellent performance of 92.11% sensitivity and 99.52% specificity have been proven through clinical trials. It is effective in diagnosing mutated viruses because it targets nucleocapsid proteins, which are easily mutated, as well as nucleocapsid proteins, and can be detected only with 0.1 ng of nucleocapsid proteins per ml in minimum detection limit analysis. Daewoong Pharmaceutical, which started selling in Korea in mid-February this year for the first time in the diagnostic business area, settled in the domestic market by selling to more than 1,000 open stores and small and medium-sized hospitals within two months of its release. With COVID-19 recently entering a phase of re-proliferation, it plans to expand its market share in Korea and expand its appearance to various screening areas such as COVID-19 and influenza dual test kits in the future. Daewoong Pharmaceutical signed a 12 billion won COVID-19 diagnostic kit export sales contract with Vietnam's large pharmaceutical company Vietha Pharma Corp at the end of last year and completed local quality testing approval and is proceeding with the final approval process. Daewoong Pharmaceutical plans to continue its diagnostic kit business globally based on its experience in entering the COVID-19 diagnostic kit business accumulated in Korea and Vietnam. According to an official from Daewoong Pharmaceutical, in addition to the COVID-19 diagnostic kit, it plans to expand its business to countries around the world in various fields such as ▲B, hepatitis C ▲ HIV antibody ▲ dengue fever antigen/antibody kit, and is recently negotiating visible contract conditions for entry into Thailand. According to the Global In-Vitro Diagnostics Market of Allied Market Research, a market research institute, the global in-vitro diagnostics market reached $71.4 billion (about 94 trillion won) in 2020 and is expected to grow 4.08% annually to $106.9 billion (about 141 trillion won) in 2030. Among them, the annual average growth rate of the infectious disease diagnosis market is the highest at 6.3%, which is expected to reach $35.8 billion (about 47 trillion won) in 2027.
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- Rising status of antidiabetic SGLT-2 inhibitors
- by Jul 26, 2022 06:05am
- SGLT-2 inhibitors made an external growth of 16% in the first half of this year. SGLT-2 inhibitors, which were first approved as a type 2 diabetes treatment, expanded into the field of heart failure and made over ₩80 billion in prescriptions in the first half of the year. Being recently recommended as a major treatment option in treating chronic heart failure in domestic treatment guidelines, the growth in sales of SGLT-2 inhibitors is expected to continue to gain momentum. ◆ Makes ₩82 billion in total prescriptions …AZ ₩43.8 billion ·BI ₩35.7 billion According to the market research institution UBIST on the 25th, the total outpatient prescriptions made for SGLT-2 inhibitors in the first half of this year rose 15.7% from ₩70.9 billion YoY to record ₩82 billion. The SGLT-2 inhibitor market size, which had been ₩50 billion 5 years ago, has been steadily expanding with the introduction of combination drugs and indication expansions. In 2019, the half-year prescription amount exceeded ₩50 billion in 2019 for the first time and was on the verge of achieving annual sales of ₩100 billion. Last year, the annual prescription amount exceeded ₩150 billion. This growth in the SGLT-2 inhibitor market was led by AstraZeneca and Boehringer Ingelheim, which had been actively expanding their drug’s indications. Prescriptions of AstraZeneca’s monotherapy “Forxiga (dapagliflozin)” and its metformin combo “Xigduo” makes up 53% of the total SGLT-2 inhibitor prescription market. Boehringer Ingelheim’s single agent drug “Jardiance (empagliflozin)” and its combo drug “Jardiance Duo” accounts for 44% of the market. AstraZeneca’s Forxiga has solidified its lead in the market by being the first to obtain an indication as a treatment for chronic heart failure in 2020. Its outpatient prescriptions in the first half of the year were ₩23.4 billion, a 16.7% YoY increase from the ₩20 billion made in the same period of the previous year. The combo drug Xigduo’s sales also increased 18.5% from ₩17.2 billion to ₩20.4 billion from the previous year. The prescriptions of the two drugs amounted to ₩43.8 billion. The half-year sales of Boehringer Ingelheim’s Jardiance first exceeded ₩20 billion this year. Jardiance’s outpatient prescriptions in 1H this year were ₩21.2 billion, a 7.5% increase from the ₩19.7 billion in 1H of the previous year. Jardiance Duo’s sales also increased 28.1% from ₩11.3 billion to ₩14.5 billion. Total prescriptions of Jardiance and Jardiance Duo amounted to ₩35.7 billion in 1H this year. ◆Rises as a key drug in HF… Receives 'Class 1 recommendation’ in all areas of HF The status of SGLT-2 inhibitors, which are already likened to ‘21st-century statin,’ is expected to continue to rise with its recommendation as a standard of care therapy in the latest heart failure treatment guidelines in Korea. In the “Completely Revised Heart Failure Clinical Practice Guidelines 2022” that was published by the Korean Society of Heart Failure (KSHF) on the 22nd, SGLT-2 inhibitors were recommended for administration regardless of the patient’s diabetic status to reduce hospitalization from HF or cardiovascular deaths. In detail, in heart failure with reduced ejection fraction (EF of 40% or lower), SGLT-2 inhibitors were recommended in line with ARNI or ACE inhibitors (angiotensin-converting enzyme inhibitor), beta-blockers, and saline corticoid receptor antagonist (aldosterone antagonist) as a first-line standard of care for reducing cardiovascular deaths and rehospitalization from HF, regardless of the patient’s diabetic status. (Class I, Level of Evidence A). In heart failure with mildly reduced ejection fraction (EF of 41-49%) and heart failure with preserved ejection fraction (EF of 50% or higher), SGLT-2 inhibitors were recommended at a higher level than ARNI or ARB (angiotensin receptor blockers), etc. (Class I, Level of Evidence B) In addition, the guideline recommends SGLT-2 inhibitors as standard therapy for diabetic patients who already have cardiovascular disease or are at high risk of developing cardiovascular disease, even without heart failure. (Class I, Level of Evidence A).
