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- Pradaxa and Xarelto to face generic market opening up soon
- by Kim, Jin-Gu Dec 30, 2020 06:03am
- Six South Korean pharmaceutical companies that successfully evaded Pradaxa (dabigatran) and Xarelto’s (rivaroxaban) patents would release generics in advance in July next year. The industry predicts the non-Vitamin K antagonist oral anticoagulants (NOAC) market currently led by the originals would take a sharp turn soon. Moreover, a generic version of dipeptidyl peptidase-4 (DPP-4) inhibitor Galvus (vildagliptin) would be launched soon with the preferential sales rights. Also, Brilinta (ticagrelor) generic market would be opened late next year with 25 South Korean companies backed by the preferential sales right. ◆ Generic market for Pradaxa and Xarelto to open in July and October next year, respectively On Dec. 28, the Ministry of Food and Drug Safety (MFDS) and the Korean Intellectual Property Office (KIPO) announced the preferential sales rights would be granted on total 37 items from next year. First, four companies that overcame NOAC Pradaxa’s patent are to release their generics early on July 18 next year. Intro Bio Pharma’s Dabican, Aju Pharm’s Dabitran, Jinyang Pharm’s Pradabi and Huon’s Hubitran are the generic by the four companies. The four companies won the patent dispute against the original drug company Boehringer Ingelheim in January 2019. The obtained preferential sales rights are to last until April 2022. Another NOAC, Xarelto is also expecting its generic versions to emerge after Oct. 4 next year. Hanmi Pharmaceutical’s Riroxban and SK Chemical’s SK Rivaroxaban have been preparing for the launch. The wildcard is actually Chong Kun Dang, who challenged Xarelto’s product patent that neither one of the two companies could not overcome. If the court rules in favor of Chong Kun Dang by Oct. 4 next year, the company would be able to market the product even before Hanmi Pharmaceutical and SK Chemical regardless of the preferential sales rights. So far, the NOAC market was predominantly occupied by the original Eliquis, Pradaxa, Xarelto and Lixiana. But, soon the generics would tackle the market with the boost from Xarelto generic. In fact, Eliquis’ patent was challenged the first. In May 2018, Chong Kun Dang and Yuhan Corporation received the preferential sales rights and launched their generics after June 2019. Now the preferential sales period has ended and 12 generic companies are expanding their market share. And in next year, only Lixiana would be the one without generic competitors. Considering Lixiana generic would tap on the market in 2026, the original would dominate the market for a while longer. ◆25 Brilinta generics to rush into the market from November next year An antidiabetic DDP-4 inhibitor developed by Novartis, Galvus is expecting its generic version to be released in advance on Aug. 30 next year Ahn-gook Pharm (including Ahn-gook New Pharm) would exclusively practice the generic preferential sales right. The South Korean company succeeded in nullifying the extended original patent term. But the relevant patent dispute has not been settled completely, yet. As Novartis took the case to a higher court, the Supreme Court would be making the final decision. After Nov. 21 next year, Brilinta’s generics would be released early. About 30 pharmaceutical companies in South Korea challenged AstraZeneca’s antiplatelet drug patent. Ultimately, Chong Kun Dang successfully won 25 claims and received the preferential rights. ◆Preferential sales right period on Betmiga generic ended, nine generic companies ready to take off Meanwhile, some generics’ preferential sales benefit would be terminated soon. On Jan. 8, the benefits on desvenlafaxine generics would be taken away. Its original is Pfizer’s antidepressant Pristiq Extended Release Tablet. Whanin Pharm, Nexpharm Korea, Myung In Pharm and Hanlim Pharm got the preferential sales rights in last April. From Feb. 3, two mirabegron generics would no longer protected by the preferential sales rights. Astellas’ overactive bladder treatment Betmiga is the original. As Hanmi Pharmaceutical and Chong Kun Dang successfully challenged the patent, they respectively released Mirabek and Selebeta. As Betmiga generates around 70 billion won annually, the generic companies would aggressively jump into the market after February when the preferential sales period ends. Currently, nine companies, including Hanmi Pharmaceutical, Chong Kun Dang, JW Pharmaceutical, Daewoong Pharmaceutical and etc., have evaded the patent and some of them even completed the bioequivalence test and are fully prepared for the launch already.
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- Samsung Bio & Hanmi will participate at JPM 2021
- by Kim, Jin-Gu Dec 30, 2020 06:02am
- At the 38th JPMorgan Healthcare Conference held this year, Kwon Se-chang, President of Hanmi, announces R&D strategies. This 39th event will be held online under the influence of COVID-19 20 domestic pharmaceutical bio companies announced their participation in the JPMorgan Healthcare Conference, which will be held early next year. Among them, Samsung Biologics was the only one to be assigned a main session presentation. Celltrion, who attended every time, declared absence after 10 years. The JPMorgan Healthcare Conference, which marks its 39th year next year, is the largest conference in the bio field where global pharmaceutical companies share new drug R&D achievements and status, and understand trends in the global pharmaceutical industry. This conference will be held online from January 11th to 14th due to COVID-19. ◆Samsung Biologics debuts as new president, John Rim There were about 20 domestic companies that announced their participation in the JPMorgan conference by the 28th. Samsung Biologics is one company that has been assigned the main track. The announcement was scheduled for the morning of the 13th. Although the details of the announcement have not been decided yet, it is attracting attention in that it is the first official stage of the newly appointed John Rim. Hanmi, Hugel, HK inno.N, LG Chem, and Genexine were assigned to announce an auxiliary session (Emerging Market Track). Hanmi is scheduled to announce on the afternoon of the 11th and the rest of the companies on the morning of the 13th. Hanmi has not yet decided on a specific announcement. Last year, they announced HM15211, which is being developed as a treatment for NASH. Hanmi has released three HM15211-related research results in succession this year at the European Association for the Study of the Liver and the American Association for the Study of Liver Diseases. The Food and Drug Administration (FDA) has designated this substance as Fast Track. HK inno.N is participating in this event for the first time. HK Innoen plans to introduce autoimmune disease treatment and NASH treatment, including Kcab. Genexine will introduce the business strategy of Continuous Interleukin-7 (GX-17). GX-17 is a substance under development as an anticancer drug for various indications and a treatment for COVID-19. Celltrion, a regular member of JPM conference, decided to absent after 10 years. Celltrion was initially reported to have been assigned to the main track along with Samsung Biologics, but will not attend this event to focus on the development of corona antibody treatment. ◆Bio companies such as Enjikem·Genome & Co have also declared participation Enjikem·Genome & Co·ABL Bio·Crystalgenomics· AptaBio·SCM LifeScience Co Ltd·Cellivery·KoBioLabs·Bioleaders·Eoflow are also planning to participate in this JP Morgan conference. Enjikem introduces EC-18, which is being developed as a treatment for COVID-19, and a treatment for oral mucositis caused by chemoradiation on cancer. Phase II clinical trials for oral mucositis are in the final stage. The company plans to announce the results of Phase II in the first half of next year. Genome & Co plans to discuss technology transfer of pipelines such as new immune checkpoint inhibitors and autism treatments. At last year's JP Morgan conference, discussions on additional co-development of GEN-001, a microbiome-based immune anticancer drug, jointly developed with Merck and Pfizer will also be in progress. ABL Bio plans to focus on its dual antibody platform Grabody-B, which increases the penetration rate of the blood-brain barrier, and ABL301, a Parkinson's disease treatment that introduced it. Crystalgenomics will be presenting the data of Ivaltinostat, CG-745', a new drug candidate for anticancer and antifibrosis treatment. AptaBio introduces the company's core platform technology and pipeline, focusing on the diabetic nephropathy treatment APX-115. APX-115 is undergoing multi-national phase II clinical trials in Europe. Patients started medication for the first time in September, and interim data is expected to be available in the first quarter of next year. Cellivery will announce the efficacy and development status of its immunotherapy iCP-NI as a treatment for COVID-19. In addition, it plans to release data on the efficacy of iCP-Parkin, a dementia treatment drug that utilizes TSDT, a drug substance transmission technology in vivo. KoBioLabs shares the clinical progress of major microbiome new drug pipelines, such as KBLP-001 and KBLP-002, the immune disease tasks that are undergoing global clinical trials. In addition, KBLP-004, a microbiome-derived effective substance-based NASH treatment, plans to explore the possibility of joint research and technology transfer from a preclinical study based on the research results on a new target identified by KoBioLabs. Bioleaders introduces research and clinical programs using Huma MAX and MucoMAX technology, which are self-developed new drug platforms. It is also planning to discuss the licensing of anticancer drugs and Sacopenia candidates as well as clinical trials for cervical intraepithelial neoplasia and Duchenne muscular dystrophy treatments. Expectations and concerns coexist in the pharmaceutical industry over this event, which is held online for the first time in 39 years. While there are concerns that the opportunity for business meetings will decrease, there is also an expectation that more active meetings will be possible because there are no temporal and spatial constraints.
- Company
- Successful year for Korean new drug, biosimilar and test kit
- by An, Kyung-Jin Dec 29, 2020 06:09am
- The year 2020 was a fruitful year for the South Korean companies and their R&D outcomes showcased in the global market. Yuhan Corporation licensed out its novel lung cancer treatment ‘lazertinib’ to Janssen for 100 billion won. SK Biopharmaceutical put the gears in motion for its anti-epileptic drug Xcopri sales in the U.S. market. The previously neglected diagnostic testing kit manufacturers emerged amid COVDI-19 as the success cases of the infectious disease prevention in South Korea. Samsung Bioepis and Celltrion broke the export record with their competitively priced biosimilars. ◆Yuhan’s Lazertinib confirms 100 percent response rate, the milestone pays out 100 billion won A number of new drugs developed by South Korean pharmaceutical companies have been impactful in the global market this year. An image of Yuhan Corporation HQ Yuhan met the development milestone for the novel lung cancer drug lazertinib, licensed to Janssen Biotech two years ago, and received a milestone payment of total USD 10 million paid out in April and November this year. Lazertinib is a third generation epidermal growth factor receptor (EGFR) targeted therapy Yuhan licensed out to Janssen Biotech in November 2018. The Korean company signed the deal with the 50 million-dollar upfront payment and maximum payment of 1.25 billion dollars including clinical, approval and sales milestones. At the ‘European Society for Medical Oncology (ESMO) Virtual Congress 2020’ convened in last September, Janssen presented a Phase Ib interim report on confirming an outstanding response rate in lazertinib combined with amivantamab. 20 non-small cell lung cancer (NSCLC) patients with no previous treatment history, who have either EGFR exon 19 deletion or L858R mutation, have been treated with the lazertinib combination therapy and reached 100 percent objective response rate (ORR) in seven months. Besides lazertinib, Yuhan has also inked five new drug technology license out deals in last two years. When the non-alcoholic steatohepatitis (NASH) treatment candidate, licensed out to Boehringer Ingelheim, completed the non-clinical toxicity test in last April, Yuhan acquired 10 million dollars. Within this year, Yuhan generated total of 77.9 billion won for the license out contracts, which vastly exceeds 57.1 billion won, the operating income accumulated up to third quarter. As the value of licensing out new drug commercialization has gone up, the Korean company successfully overcame the risk of faltering sales with expanded R&D investment. ◆SK’s Xcopri commercialized in the U.S. New drugs developed by SK Biopharmaceutical’s own technology are also seeing some satisfying commercialization outcomes. SK Biopharmaceutical has generated 9.9 billion won as of the third quarter this year. The statistic report found a narcolepsy treatment Sunosi (solriamfetol), licensed out to Jazz Pharmaceutical in 2011, generated 4.6 billion won and a partial-onset seizure treatment Xcopri (cenobamate) generated 5.3 billion won. Although the figure is insignificant compared to last year’s sales 123.6 billion won, making almost 10 billion won from the license out sales was remarkable. Currently, SK Biopharmaceutical has diversified commercialization strategy for Xcopri in respective regions. For the world’s biggest U.S. market, the Korean company’s subsidiary in the region SK LifeScience directly launched the product in last May. Also the company plans to directly handle the Xcopri commercialization in Japan, China and South Korea, but for other regions like Europe, the company plans to seek a local partner. ◆COVID-19 testing kit '99.9 percent for export' Testing kit companies in South Korea had an unexpectedly successful year due to the pandemic. One of the top companies who benefitted from the global pandemic is a molecular testing kit specialist company Seegene. The company’s accumulated operating income up to the third quarter skyrocketed by 24 times from 17.3 billion won last year to 418.7 billion won this year. During the three quarters, the company generated 683.5 billion won of sales revenue, which is more than eight-folds of last year’s. Among all healthcare companies in South Korea, Seegene came in second with the operating income following Celltrion making 245.3 billion won. The operating income against sales revenue marked 64.9 percent. If the sales revenue actually exceeds the company’s projection for this year at 1 trillion won, the company would be making almost ten-folds of last year at 122 billion won. Seegene COVID-19 test kit Seegene had a record breaking performance by proactively developing COVID-19 testing kit to help diagnose the infectious disease in suspected patients during the early stage of COVID-19 outbreak. The company exports the COVID-19 relevant products out to 70 countries. As of the third quarter, the 94.4 percent, or 645.4 billion won, of the overall sales revenue was from the export. Regardless of the swift distribution of COVID-19 vaccine in the U.S. and other countries, the industry projects the worldly demand for the testing kit would remain high for a while. ◆Celltrion and Samsung Bioepis break quarterly revenue Amid COVID-19, South Korea’s top biosimilar companies continued to exceed top export records with successful portfolio. Celltrion (left) and Samsung Bioepis R&D laboratory (Source: respective companies) Celltrion Healthcare easily passed last year’s annual sales revenue at 1.10 trillion won by earning 1.24 trillion won as of the third quarter this year. Celltrion Healthcare sells Celltrion’s biosimilar products to global distributors. Basically, Celltrion Healthcare’s sales revenue indicates Celltrion’s antibody biosimilar export volume. Mabthera’s biosimilar Truxima, prescribed to patients with blood cancer and rheumatoid arthritis, topped the leader board by selling 590.5 billion won as of the third quarter. Celltrion’s U.S. partner Teva reported Truxima’s market share reached 20.4 percent as of September, which was only 11 months after the U.S. market launch. The company also noted the drug is threatening the original’s top position with the drug’s strength of being the first rituximab biosimilar anticancer treatment. Breaking its own top record, Samsung Bioepis’ third quarter sales revenue of 236.9 billion won grew 2.3 percent from last year at 231.6 billion won. Although COVID-19 has slowed down the growth, the company made a new quarterly revenue record in a year as the biosimilar sales in Europe surged. Samsung Bioepis’ European partner Biogen said three biosimilar products combined—Benepali, Flixabi and Imraldi—have earned 27.9 million dollars (approximately 235.7 billion won) in the last third quarter. The Korean company’s Enbrel biosimilar Benepali was the first product to tap on the European market, and it made 124.20 million dollars, jumping 7.2 percent from last year same time.
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- High import drug dependency, Korean drug ratio keeps falling
- by Chon, Seung-Hyun Dec 29, 2020 06:08am
- The dependency on imported pharmaceutical products in the South Korean market seems to be getting higher. The volume of the country’s locally manufactured complete product and active pharmaceutical ingredient (API) has fallen for two consecutive years. The self-sufficiency in API has even halved in just two years. According to the ‘Food and Drug Statistics 2020’ published by the Ministry of Food and Drug Safety (MFDS) on Dec. 25, the production of Korean-made complete drug has increased by 7.0 percent this year, compared to last year, reaching 19.84 trillion won. The complete product import generated 4.77 trillion won, surging 20.0 percent this year compared to 2018, when the import volume was also increased by 13.0 percent hitting 5.25 trillion won. The ratio of complete drug manufacturing self-sufficiency in 2018 was 74.1 percent, which was 1.5 percent lower than the previous year. The self-sufficiency ratio indicates the proportion of the Korean-made products in the overall market. The self-sufficiency ratio in complete product in 2017 reached 77.6 percent, and the figure has been dipping for last two consecutive years and marked the lowest since 2008, when the statistics disclosed for the first time. The ratio in 2008 marked 83.4 percent. The figure fell below 80 percent in 2012 and then it has been slipping down ever since. The industry analyzes the drop in Korean-made complete drug’s local market share would have been affected by the heightened preference on imported drug and disinterest in generics. As an off-patent new drug pricing is brought down to level with generics, the prescribers appear to prefer the originals more than the generics. In South Korea, the original’s reimbursed pricing is reduced to 70 percent of the initial pricing when a generic is released to the market. And the pricing falls again to 53.55 percent of the initial pricing a year after the pricing adjustment. As for generic, the initial upper limit pricing is set at maximum 59 percent of the original pricing before the patent expiration, and it would be reduced down to 53.55 percent the initial pricing after a year like the original. The yearly ratio of Korean-made complete drug in the local market (Unit: percent) Source: MFDS Meanwhile, the dependency on the imported API is rising steeply. South Korea has manufactured 2.47 trillion won worth of API in last year, which was 3.6 percent less than the year before. But API export volume was increased 13.4 percent more than 2018 with 1.98 trillion won, while the import volume was increased 11.6 percent more with 2.53 trillion won. The self-sufficiency ratio in API marked 16.2 percent making over 10 percent point drop. After reaching 35.5 percent in 2017, the figure took a significant fall for two consecutive years. Last year’s API self-sufficiency ratio did not even make it to the halfway point of 35.4 percent recorded in 2017. The pharmaceutical companies evaluate the import volume surged as the Korean manufacturers sought after inexpensive imported API to lessen the production cost. In last year alone, USD 796.96 million worth of Chinese-made API were imported, which was 17.5 percent more than the year before with 678.09 million dollars. Compared to 653.66 million dollars of import in 2017, the volume in last year leaped by 31.6 percent in two years. Meanwhile, the Indian-made API import volume also jumped from 171.89 million dollars in 2017 to 221.14 million dollars last year.
- Company
- Technology exports are active despite COVID-19 outbreak
- by An, Kyung-Jin Dec 28, 2020 06:14am
- The world is struggling with the surprise attack of COVID-19, but domestic pharmaceutical and bio companies' new drug technology export performance is very active. SK Biopharm received the most down payment for the second consecutive year as it transferred the copyright to the Japanese region for a new epilepsy drug developed with its own technology. Yuhan and JW Pharma have made the achievement of transferring new drug technology to overseas pharmaceutical companies for the third consecutive year since 2018. The share of technology exports from bio-ventures with platform technologies such as Alteogen and LegoChem Biosciences has increased significantly. ◆ Bio-venture activities and new drug technology exports are '4 out of 5' Number and scale of technology export contracts for major pharmaceutical bio companies in 2019-2020 (Unit: case, ₩100 million, Source: Financial Supervisory Service, each company) This year, 10 domestic pharmaceutical and bio companies have signed a total of 15 technology export contracts with foreign companies. Compared to last year, when 12 companies won 14 contracts, the number of contracting companies decreased by two, but the number of contracts increased by one. Technology exports are estimated to be ₩10 trillion, up 19.4% from last year. The driving force behind the breakthrough of ₩10.15 trillion in technology exports is bio-ventures, while the world is in a chaotic state due to COVID-19 outbreak. In April, LegoChem Biosciences signed a contract with Iksuda Therapeutics in the UK to transfer the original technology of antibody-drug complex (ADC) worth About ₩496.3 billion. ADC (Antibody-Drug Conjugates) is a technology that enhances therapeutic effect by accurately delivering drugs bound to antibodies to antigens. A total of five contracts signed by LegoChem Biosciences for a year using original technology. In May, the company passed an ADC-based anticancer drug to Iksuda and won an additional contract worth $227 million, and in October, it signed a technology export contract with CStone Pharmaceuticals in China for up to $363.5 million for ADC anticancer drugs. In December, it signed a technology export contract with Pyxis Oncology in the US and two pharmaceutical companies in Japan, respectively, related to ADC anticancer drugs. In the case of transferring the copyright of three ADC-based anticancer drugs to Takeda subsidiary Millennium Pharmaceuticals in March last year, it means that six contracts were signed with the same technology. In addition to LegoChem Biosciences, relatively small-scale bio-ventures showed outstanding technology export performance. 12 out of 15 new drug technology transfer contracts signed by domestic companies this year are achievements made by 7 bio companies including LegoChem, Futurechem, Alteogen, OliX, Voronoi, Genexin, and SK Biopharm. Alteogen received $16 million as a down payment when it passed the right to use the source technology for Hybrozyme to 10 global pharmaceutical companies in June. The technical fee for each stage according to clinical development, marketing authorization, and sales performance amounts to a total of $3.8 billion. Alteogen's original technology for Hyaluronidase is a technology that enables large amounts of subcutaneous administration of all biologics administered intravenously. By taking advantage of the scalability of the original technology that can be applied to various new drug development processes, it achieved an additional contract conclusion in 7 months following last November. Futurechem signed a contract for a total of €1.22 million with IASON GmbH in Austria in May for the diagnosis of prostate cancer, followed by a technology transfer contract worth about ₩650 billion with HTA in China in September. In addition, it is counted that OliX, Voronoi, and Genexine have been handed over. ◆SK Biopharmaceuticals No. 1 in contract payments, JW's outstanding global technology export for 3 consecutive years Among the technology transfer contracts signed this year, SK Biopharm's epilepsy treatment Xcopri (Cenobamate) received the largest down payment. SK Biopharm secured approximately ₩54.5 billion in deposit without obligation to return when it signed a technology transfer contract with Ono Pharm. The milestone according to the achievement of permission and commercialization is up to about ₩524.3 billion. After commercialization, sales royalties of 10% or more were guaranteed. SK Biopharm secured a down payment of ₩54.5 billion this year, the eighth largest of the domestic pharmaceutical industry. SK Biopharm also signed a total of $530 million worth of Xcopri contracts with Swiss Arvelle Therapeutics last year. The down payment secured at the time was $100 million, which is the third largest in history. It has maintained the No. 1 position in technology export contract payments for two years in a row by being recognized for the value of being approved by the US Food and Drug Administration (FDA) as first-in-class with a new mechanism. The size of the upfront of major pharmaceutical bio companies that signed a technology export contract in 2020 (Unit: ₩100 million, Source: Financial Supervisory Service) JW Holdings' nutrient solution technology export contract was the highest in the proportion of the total amount of technology exports. It has signed a technology export and supply contract for Winuf, a comprehensive nutrient solution, with Shandong Luoxin Pharmaceutical, a subsidiary of Luoxin Pharmaceutical in China. The total down payment is $39 million. The down payment without obligation to return is $5 million, which accounts for 12.8% of the total down payment. Winuf is a three-chamber comprehensive nutrient solution that can be easily mixed and used with three ingredients such as lipid, glucose and amino acids by dividing one container into three. It is composed of four lipid components, such as refined fish oil (20%), refined soybean oil (30%), olive oil (25%), and MCT (25%), as well as glucose and amino acids. It is known that it contains a higher content of refined fish oil than existing products, so it contains more omega 3 and omega 6 fatty acids that promote the improvement and recovery of patients' immunity. Previously, there was no case of commercialization of a third-generation comprehensive nutrient solution containing refined fish oil in China, and JW Life Science signed a high-purity contract with a high proportion of down payments as it was recognized for the distinction that JW Life Sciences is in charge of producing finished products after Winuf in China. It is an evaluation that it was possible. It has signed a global technology export contract for 3 consecutive years, starting with the technology transfer contract for atopic dermatitis new drug with Leo Pharma in 2018. ◆SK Biopharmaceuticals No. 1 in contract payments, JW Group's outstanding global technology export for 3 consecutive years The technology transfer contract between Hanmi and Yuhan is also a meaningful R&D achievement this year. Hanmi transferred the GLP-1-based dual agonist returned from Janssen back to MSD within one year. It is a dual-acting treatment that simultaneously activates GLP-1, which helps secretion of insulin and suppresses appetite, and glucagon, which increases energy metabolism, and the original technology of Hanmi Pharmaceutical's LAPSCOVERY, which increases the duration of the drug, was applied. The contract fee, which is not obligated to return, is $10 million, and the maximum contract size, including staged technical fees (milestone), is $870 million. It was positively evaluated for discovering new potential in the field of non-alcoholic steatohepatitis (NASH) instead of diabetes and obesity, which were the existing indications, leading to a new contract. Yuhan made a turning point by handing over gastrointestinal disease treatment candidates, which had been pending for nearly two years, to a small overseas bio-venture without obtaining satisfactory results in the domestic II clinical trial. Yuhan received $2 million of Procesa shares as a down payment by handing over the global copyright of the new functional gastrointestinal disease drug YH12852 to Processa Pharmaceuticals. The maximum contract size, including staged technology fee (milestone), is up to $410.5 million. After commercialization, it was agreed to receive a certain percentage of net sales as royalties. Processa Pharmaceuticals, a partner, will be listed on Nasdaq after the signing of the contract, and is looking forward to further development, saying that it will pursue a phase II clinical trial in the US early next year. Technology export status of major pharmaceutical bio companies in 2020 (Source: Financial Supervisory Service, each company) However, except for SK Biopharm and JW Pharma, the share of down payments in the total amount of technology exports was only 3%. While the overall contract size increased, the proportion of down payments decreased relatively as option contracts and comprehensive platform technology contracts for which the inflow of subsequent milestones was uncertain.
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- Hanmi and SK win the final round of Xarelto patent dispute
- by Kim, Jin-Gu Dec 28, 2020 06:13am
- South Korean pharmaceutical companies won the patent dispute on Bayer’s non-Vitamin K antagonist oral anticoagulants (NOAC) Xarelto (rivaroxaban). As a result, Hanmi Pharmaceutical and SK Chemicals have overcome the last obstacle to prepare an early launch of rivaroxaban generic in next October. On Dec. 24, the Supreme Court ruled in favor of Hanmi Pharmaceutical and SK Chemicals for the third ruling on the negative confirmation scope in Xarelto’s composition patent. Besides the latest case, Hanmi has also won the patent nullification case as well. The patent dispute started from March 2015, when the two companies filed a negative scope confirmation on Bayer’s original tablet. The two Korean companies won the first ruling, and they earned the preferential sales rights after they received the item approval in 2016. However, Bayer disagreeing with the ruling filed an appeal to the Patent Court. But the second ruling remained unchanged from the first. The multinational company then filed the last appeal. The case initiated from November 2016 at the Supreme Court was concluded four years after, bringing good news to the generic companies. Bayer requested for trials for correction, while arguing the case, to lessen the claim but the company also lost the patent nullification case as well. The final ruling was the last step towards the early generic release for Hanmi and SK. The two companies’ generic may be marketed from October 2021 with preferential sales rights lasting until July 3, 2022. A pharmaceutical market research firm UBIST found Xarelto has generated total 50.8 billion won for the outpatient prescription. As of the third quarter this year, 37.6 billion won worth of the drug was prescribed. Now the industry’s interest is shifting towards Chong Kun Dang, who started taking legal action to evade Xarelto’s substance patent. If Chong Kun Dang succeeds in evading the substance patent to be expired in October 2021, the company would be able to launch its generic even before Hanmi and SK.
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- Multinational companies enjoy winter holidays up to 17 days
- by Eo, Yun-Ho Dec 24, 2020 06:10am
- Current status of winter holidays of 20 multinational companiesThis year, a number of multinational pharmaceutical companies' executives and staff members are entering long-term winter holidays. As a result of Dailypharm's survey of the year-end holidays of 20 major multinational companies on the 23rd, it was confirmed that more than 10 companies designated winter holidays for more than 10 days. In particular, as January 1, 2021 turns to Friday, two days of weekend holidays are added to January 2 and January 3, making the holiday season longer. The company with the longest holidays is GSK. The company will be closed for 17 days from the 18th to the 3rd of January 2021. AstraZeneca's employees are also given 14 days of vacation. The company was originally scheduled to start winter holidays from the 23rd, but with the addition of two days of special holidays from the global CEO, the company will enjoy the holidays from the 21st. In addition, Sanofi will be closed from the 22nd, Novartis, Viatris, Pfizer, and BMS will start on the 23rd, Daiichisankyo, Roche, and Boehringer Ingelheim will begin the holiday from the 24th, and Astellas will begin the holiday from the 25th. As of Christmas, a total of 11 pharmaceutical companies will be closed. The KRPIA and MSD start vacations from the late 28th. Most multinational pharmaceutical companies such as Galderma, Gilead, Lilly, Merck, Bayer, Amgen, Janssen, AbbVie, and Eisai have winter holidays using Voluntarily paid off. These multinational employees enjoy a minimum of 10 days off although voluntarily paid off. Even if it is not a designated holiday, many multinational employees are actually starting a break from this week. An official from a multinational company said, "Including the total holidays, there are many employees who take a break for more than 20 days. I am happy to have time to recharge because the industry as a whole has been busy in the aftermath of COVID-19."
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- “Need to set up cold chain for COVID-19 vaccine ASAP”
- by Dec 24, 2020 06:09am
- Professor Lee Jae Hyun “Pfizer and Moderna both use mRNA type of COVID-19 vaccines and it is a highly unstable substance that requires exceptional level of cold chain management. Especially, the response plan on how to react on an emergency, for instance malfunctioning storage tool or power outage, is the most important part.” A Sungkyunkwan University College of Pharmacy professor, Dr. Lee Jae Hyun said as above on Dec. 21 at the Korea Pharmaceutical Distribution Association (KPDA) ‘Pharmaceutical Distribution Development Forum 2020’ that opened a discussion on the current pharmaceutical cold chain in South Korea and related solutions. As the number of biological drugs like vaccine is climbing, the drug distribution industry has to inevitably take account of cold chain. More specifically, Pfizer and Moderna have developed COVID-19 vaccine based on the novel technology using mRNA, which demands highly intricate control of the environment. However, only a handful of companies in the South Korean drug distribution industry has a cold chain for general biological medicine, not even suitable for the mRNA vaccine. Also at the forum, the chairman of KPDA Cho Sun-hye said, “Because the core of our industry is pharmaceutical distribution, we must achieve the hegemony in cold chain. And this forum was organized to swiftly and preemptively establish infrastructure for the cold chain market, and to prepare ourselves for the changes.” A cold chain is an environment with overall temperature control used to store and distribute biological drugs at its optimal state. The most integral part of cold chain is maintaining the optimal temperature for the entire process of distribution. Professor Lee Jae Hyun introduced a vaccine cold chain guideline and explained of the vaccine storing and distribution the industry is paying a close attention to these days. The professor elaborated, “The primary factor is to set a system that defines how to handle storing and shipping when using cold chain, what type of transportation cradle would be prepared and how to get to the destination. And also a validation system is needed to confirm the preparation of the system.” Dr. Lee stressed the cold chain has to be ready to handle emergency situation like malfunctioning and power outage. Moreover, a supply manager and quality control manager should be appointed to document the vaccine management criteria according the Good Distribution Practice (GDP). A wholesale manager can personally check the vaccine shipment, but a separate vaccine management staff should be designated with a proper training to react appropriately and timely to an emergency situation. A general prerequisite of a vaccine cold chain storage is a space that can maintain an adequate temperature and level of humidity. Refrigerated storage or a deep freezer has to use a biologic-specific fridge with an automatic thermostat. The professor highlighted, “Vaccine’s stock can vary depending on the season, but a distributor should have a sufficient space to manage all stock and more for the needed equipments.” The storage equipment has to be strictly maintained regularly, and it has to be kept clean all the time to ensure there is no dust on the heat conducting coil or motor. The storage equipment has to be validated for its adequate temperature via temperature mapping, which confirms well distributed target temperature in all spaces by using the temperature sensor and finding the maximum and minimum value. Professor Lee said, “Although an expert specialist can be hired to maintain the storage, especially for temperature and humidity, environmental hygiene and protection against pests and weather, the wholesale distributor would be held responsible so the company should visit and check the site regularly.” As soon as vaccines arrive, they would be moved to the storage immediately. And the staff in charge would have to record the arrival date and time, the name of acceptor and maintenance staff, the state of the vaccine with the corresponding solvent at the time of arrival, the name of vaccine accepting company, type and volume of the vaccines, and manufacturing serial number and expiration date. Professor Lee added, “For the thermostat in the vaccine cold chain, I recommend using a thermostat with tuning certification. And in case of temperature fluctuation issue caused by aged equipment, the temperature record should be archived for over two years at least.”
- Company
- Domestic companies won the first trial of 12 patents
- by Kim, Jin-Gu Dec 23, 2020 06:09am
- This year, domestic pharmaceutical companies have challenged 12 new patents. In 4 out of 12 patent disputes, generic companies have won all of them, and the remaining 8 cases have yet to be tried. According to the pharmaceutical industry on the 21st, a total of 12 patent disputes pending from January this year to this day. Daewoong and Chong Kun Dang were the most active companies to attack original patents. Each requested 4 patent trials. Subsequently, it was found that Dongkoo Bio&Pharma, Dong-A ST, Mothers Pharm, CTC Bio, Aju, Chodang, Cosmax pharma, Penmix, and Huons requested two patent trials. In addition, JW-Pharma, Kwang Dong, Daehan, Dongkwang, Myungin, Boryung, Arlico, Wooridul, Ildong, Choa, Taejoon, Theragenetex, Hana, Kolmar Korea, Hyundai, Whanin, and Huvist filed a patent trial one by one. 10 of 12 patents were owned by Global Pharmaceuticals. The remaining two were one patent for Chong Kun Dang's GERD treatment Eso Duo. Chong Kun Dang is a challenger in four other patent disputes and is defending two Eso Duo patent disputes. A total of 4 cases were concluded of the 12 patent trials filed this year. Generic companies won all four patent disputes (first trial). In February of this year, the first patent dispute began this year when JW Life Sciences requested a trial to confirm the scope of passive rights to Pfizer's Precedex (Dexmedetomidine) formulation patent. Daehan joined, too. The KIPO took the side of JW Life Sciences in the first trial. Currently, Pfizer has filed a suit to cancel the trial in the Patent Court of Korea in objection. Subsequently, on the 20th of the same month, CTC Bio filed a trial to confirm the scope of passive rights to the patent for the formulation of Chong Kun Dang's GERD treatment,Eso Duo. Aju and Chodang joined. The three companies also challenged another formulation patent for Eso Duo in September. However, Daewon and Sinil, which had challenged Eso Duo’s patent with them, voluntarily withdrew the judgment. On the 28th of the same month, Myungin challenged Eisai's Crystalline Form Patent for'Fycompa film coated tab', a treatment for epilepsy. A trial was filed with Whanin to confirm the scope of rights, and at the first trial, generic companies won. In March, Theragenetex filed an invalidation trial for a patent for the use of Handok's osteoporosis treatment Bonviva. The treatment is sold by Handok in Korea, but the patent right is in Roche. Following Theragenetex, Choa, Wooridul, Arlico, Kolmar Korea, Huvist, Ildong, Hana, Hyundai, Dongkwang joined. In the same month, Daewoong challenged two patents for the formulation of Belkyra, an injection drug for improving allergan's jaw fat. When Allergan splits the existing formulation patents and registers two new patents for patent defense, it also filed a negative trial for confirmation of the scope of rights. The dispute ended with the victory of Daewoong and Penmix. On July 22, Taejun filed a trial to confirm the scope of passive rights to a patent for the formulation of Novartis' glaucoma treatment Simbrinza (Brimonidine tartrate/Brinzolamide). The first trial is still in progress. On the 31st of the same month, Boryung filed a trial for a passive confirmation of the scope of rights against Celgene's Pomalyst. Kwang Dong joined, and the results of the first trial have not yet come out. On September 29, Daewoong challenged the formulation and use patents of Amgen's psoriasis treatment Otezla (Apremilast) at the same time. A trial for invalidation was requested for the use patent, and a trial to confirm the passive scope of rights was requested for the formulation patent. When Daewoong challenged patent of Otezla, Dong-A ST, Chong Kun Dang, Dongkoo Bio&Pharma, Mothers, Huons, and Cosmax pharma joined. The first trial is still in progress. For the last time this year, Chong Kun Dang filed a judgment for passively confirming the scope of rights to material patent of Bayer's NOAC (new oral anticoagulant) Xarelto. In the case of Xarelto, SK Chemicals and Hanmi overcame the formulation patent and received generic for exclusivity. If Chong Kun Dang succeeds in material patent, it can release generics before SK Chemicals and Hanmi.
- Company
- “30-year presence of antihypertensive Novarsc to continue"
- by Eo, Yun-Ho Dec 22, 2020 06:13am
- Dr. Kim Cheol-ho Norvasc (amlodipine) is not the world’s first calcium channel blocker (CCB). However, it is undisputedly the most famous CCB. Launched in 1990s, Norvasc was not the first-in-class but it instigated a notable change in the market with the first once-daily administration. Some say the drug marked the early beginning of the current day convenient administration marketing. A star of hypertension drug market Novarsc is now celebrating its 30 year anniversary of marketing approval in South Korea. Surely it is an old drug, but it still has its high reputation firmly built around ceaseless evolution. In 2017, Norvasc T was released to the market for the patients, who need amlodipine and telmisartan simultaneously. The company also introduced an improved bottle packaging to enhance the convenience of patients and healthcare providers storing and managing Norvasc T and to absorb the moisture of telmisartan. And besides the existing line of 5 mg and 10 mg tablets, the brand also launched 2.5 mg tablet for children from age six to 17, which was the first among all CCB original drugs for hypertension. From then on, Novarsc has been offering necessary dosage options to effectively bring down blood pressure in patients ranging from six years of age to elderly. Daily Pharm interviewed Dr. Kim Cheol-ho, a professor at Seoul National University Bundang Hospital Department of Internal Medicine to hear more about the value of Novarsc. -This year marks the 30th year for Novarsc. What was your first impression on the drug? And how was the hypertension treatment scene back then? Around 1989, I discovered Norvasc from an international journal. Back then the drug had not been introduced to South Korea, yet. During that time, only diuretics, beta-blockers and first and second generation CCBs with short duration of action were available. As amlodipine, or Norvac, was introduced, the South Korean market welcomed a once-daily calcium blocker. -How did it improve the treatment scene particularly, other than administration convenience or adherence? The drug’s coercion effect was groundbreaking. First, we used nifedipine three times a day, and then Perdipine twice a day. But when we switched to once-daily Novarsc, we found the blood pressure went down significantly. It was a shocking experience. -Since the release of Novarsc, how did the trend in hypertension treatment or cardiovascular disease prevention shift? Simply put, the paradigm had changed. Although previously we had diuretics, beta-blockers and first generation angiotensin-converting enzyme (ACE) inhibitors, their antihypertensive effects were not strong enough. But with Novarsc’s remarkable coercion effect, more patients were able to reach the target blood pressure level. Especially from 2000, when the Separation of Prescription and Dispensing (SPD) System was implemented, patients had to get prescription for drugs and the hypertension control in South Korea has gotten much better. From early 2000 to mid-2000s, the hypertension control rate in South Korea was increased from approximately 10 percent to 40 percent. CCB was an integral factor to the improvement, and Novarsc’s part in CCB was huge. -What is the latest topics addressed about hypertension control? There are two major questions—‘is the blood pressure the lower the better?’ and ‘is the treatment the earlier the better? We have not found a clear answer to the question of ‘is the blood pressure the lower the better?’ It is an issue of how much antihypertensive effect is good.’ And it relates to a definition of how high is high. Although we do not have accurate data to support how early the hypertension treatment should start, I personally advise discovering the hypertension patient in their 30s to 40s is better. Recent studies claim high blood pressure is related to a cause of dementia, so treating it from early on would help patients maintain their cognitive function as well. -Would you say the significant influence of Novarsc in hypertension management would be maintained in the future? For a long time, its presence would continue to be noticeable. It is true that the drug has contributed immensely in protecting the Korean people from cardiovascular diseases for three decades. In last decade, the improvement rate in hypertensive control in South Korea has been growing sluggishly. Almost to the point there is no growth. Both the people and the healthcare providers should pay more attention, and the government and relevant organizations should also raise awareness of the condition.
