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- 2025-12-27 12:04:08
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- Pharmaceuticals produced an average of 58 drugs 2018
- by Chon, Seung-Hyun Dec 30, 2019 06:19am
- Last year, Korean pharmaceutical companies produced 58 finished drugs on average. The amount produced per item was only ₩900 million. Among the three in 3 pharmaceutical companies, the proportion of small-scale pharmaceuticals are high, with the annual output of less than ₩1 billion. According to the '2019 Statistical Yearbook of Food and Drugs,' published by the Ministry of Food and Drug Safety on the 27th, the finished drug production totaled ₩18.5 trillion last year. It was 5.7% higher than 2017's ₩17.6 trillion. In 2010, it increased by 30.3% from ₩14,2 trillion in 2010. Last year, there were 19,239 products produced. In 2017, 52 fewer than 19,291, but 3,266 up from 15,973 in 2010. In 2018, the production performance of each drug product is calculated to be ₩ 963.86 million. Although it is gradually expanding from ₩891.17 million in 2010, it is still small scaled. Finished drug production in 2018 (left) and output per item (right) (Unit: ₩ million, Source: the Ministry of Food and Drug Safety) Last year, there were 329 drug manufacturers. Although 28 fewer than the previous year, 59 more than 270 in 2010. In 2018, an average of ₩56.4 billion of drug production was recorded per pharmaceutical company, and 58 items were produced on average. In general, domestic pharmaceutical companies handle various products and do not escape from department store management, which generates small sales per item. Drug producers (left) and number of items (right) in 2018 (Unit: numbers , Source: the Ministry of Food and Drug Safety) In fact, there were a lot of small companies that did not have a good record of finished drug production. Out of 329 drug product producers in 2018, the company recorded 32.5% of the total production of less than ₩1 billion. One out of three is a small company with less than ₩1 billion in drug production. 166 companies with less than ₩10 billion in production recorded more than half of the total. A total of 48 companies with over ₩100 billion in finished drug production were reported. More than ₩500 billion were in six places. Number of firms by size of finished drug production in 2018 (unit: Numbers , source: the Ministry of Food and Drug Safety)
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- Boryeong’s copyright of anti-cancer drug,commercial value↑
- by An, Kyung-Jin Dec 27, 2019 06:28am
- The anti-cancer drug 'Zepsyre', which is owned by Boryeong in Korea, has entered the early stage of commercialization. PharmaMar, the original developer, is expected to secure the first FDA indication for small cell lung cancer by August next year. The company also won a large contract worth up to ₩640 billion to surpass the US copyright, which is expected to be released the fastest. Boryeong signed a domestic exclusive promotional license agreement for Zepsyre from PharmaMar in November 2017. In 2016, the company signed a monopoly on sales and development of a myeloma treatment drug, Aplidin, to build a strong partnership. According to the industry on the 26th, Borm Pharmaceutical's partner, Spanish PharmaMar, recently signed a monopoly license agreement with jazz pharmaceuticals’ Lurbinectedin. Lurbinectedin is the ingredient name of 'Zepsyre', an ovarian cancer drug introduced by Boryung in November 2017. It selectively exhibits anticancer activity by inhibiting the cause of cancer. It is a mechanism that selectively inhibits the oncogenic transcriptional processes activated in cancer cells and tumor-associated macrophages (TAM) and causes cell death by cutting DNA double strands. With the deal, PharmaMar secured a $200 million deposit (approximately ₩232.2 billion) from Jazz with no obligation to return. When Zepsyre is licensed to sell the US Food and Drug Administration (FDA), it will receive up to $250 million in additional technology charges (milestones). In the future, commercial milestones were guaranteed up to $550 million in technology fees and sales royalties ranging from late 10% to 30%. Jazz is a well-known company that is a partner of 'Sonosi (Solriamfetol)', a sleep disorder new drug exported by SK Biopharm. In the industry, Jazz has secured a huge short-term milestone from Zepsyre's US market potential. PharmaMar submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) on the 17th, based on the results of the second phase clinical trial of Zepsyre. According to PharmaMar's announcement of the American Society for Clinical Oncology (ASCO 2019) in June, patients with small cell lung cancer who received Zepsyre had a significant improvement in tumor response rate (ORR) of 35.2% compared to currently available Topotecan (16.9%). In addition to small cell lung cancer, various cancers including ovarian cancer, head and neck cancer, and BRCA mutation breast cancer are being actively researched. In recognition of this potential, the company signed a licensing agreement with Luye pharmaceutical of China (including Hong Kong and Macao) in April of this year. PharmaMar's executives are confident in the FDA's rapid approval. Small cell lung cancer monotherapy, a rare disease with high unmet demand, has secured positive clinical results. Zepsyre was designated by the FDA in August last year as a rare drug for small cell lung cancer. PharmaMar expects to receive the FDA's final approval in mid-August when the document is completed early next year and undergoes a six-month quick review process. Since then, the aim is to expand the indications to various carcinomas including ovarian cancer, head and neck cancer, and breast cancer. Bruce Cozadd, Chief Executive Officer of Jazz Pharmamaticals, said, “The treatment is limited in patients with advanced small cell lung cancer. The agreement is significant because it expands the jazz anticancer pipeline and later stage assets”.
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- Discontinued sales of Champix generics
- by Kim, Min-Gun Dec 27, 2019 06:27am
- Anti-smoking drug Champix by Pfizer KoreaPfizer's Champix (Varenicline) salt-changing patent disputes have resulted in the loss of more than 20 domestic pharmaceutical companies, which has resulted in the suspension and recovery of generic drugs. According to the industry on the 24th, Hutecs Korea, C-tri, Danajen announced that they will be discontinued due to the result of a material patent evasion lawsuit by salt change of Champix This is because the patent court recently decided that “Champix generic anti-smoking drugs belong to products that differ from champix in the scope of the original material patent rights”. The ruling halted sales and prescriptions of generic products in response to a preliminary order to prohibit patent infringement. Increasingly, pharmaceutical companies are withdrawing from the market. Hutecs has discontinued its sales of 0.5mg (11 tablets, PTP packaging) and 1mg (28 tablets, PTP packaging) sold by the company. “It was due to the loss in the patent evasion litigation by changing the champix salt”, the company explained. In addition, Hutecs requested to block the code so that it is not sold to wholesale trade or nursing homes and to treat as a normal return although not subject to compulsory recall but due to discontinuation. C-tri has decided to discontinue the production of 0.5mg and 1mg of nicotine tablets. C-tri announced that there will be no future reproduction after the stock runs out and excluded from contract sales items. Danajen also stopped selling 0.5mg and 1mg of its Nicotine tablets on the 20th and began to collect all items. Danajen decided to complete the collection by the 15th of next month. In addition to coverage result of Dailypharm, the top domestic pharmaceutical companies that sell Champix generics have withdrawn from the market or are doing the same action. JW Shinyak, Chong Kun Dang, Daewoong Pharmaceutical, and Il Dong Pharmaceutical Co., Ltd ceased production and marketing. One of the pharmaceutical companies said, “We stopped prescribing and selling on the 23rd and will start returning products to pharmacies in the future, Other pharmaceutical companies also blocked both orders and sales”. An official from the PR team in Korea, who had completed the recall, said, “After the solicitation of Solifenacin, we finished preparations for the suspension and recovery early. Some pharmaceutical companies are quick to determine the profitability compared to marketing costs because they are unable to use the strategy to avoid salt changes”. On the other hand, there were some companies still watching the situation. A public relations executive at a mid-size pharmaceutical company said, “The sales department continues to sell, and we have not taken action yet”.
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- Kyowa Kirin Korea appoints Lee Sang Heon as next CEO
- by Eo, Yun-Ho Dec 26, 2019 06:30am
- 이상헌 신임 사장 On Dec. 20, Kyowa Kirin Korea announced the promotion of current Chief Operating Officer Lee Sang Heon (54) as a Chief Executive Officer from Jan. 2, 2020. Graduated from Seoul High School and Yonsei University majoring in bioengineering, soon-to-be CEO Lee Sang Heon had experience in marketing and business alliance in Boryung Pharmaceutical and JW Pharmaceutical. Since April of 2010, Lee joined Kyowa Kirin Korea as a director of management and planning and successfully served his role in business management, project development, and compliance. After being promoted as an executive managing director in 2017, CEO Lee was later appointed as COO and contributed Kyowa Kirin to secure its market leadership in the special disease treatment sector like hemato-oncology and nephrology in Korea. The current CEO Na Jong Cheon is to resign at the end of 2019.
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- Roche sets sail for more trials on Xofluza
- by Eo, Yun-Ho Dec 24, 2019 06:13am
- Following the two decade-long heritage of Tamiflu, next generation flu treatment Xofluza is quickly taking next steps to secure its market position. According to the related industry source on Dec. 24, Roche is to soon present two Phase 3 trial results of Korean health regulator-approved Xofluza (baloxavir), and the company also is prepping for three other clinical trials. The completed trials have tested efficacy of the treatment in a post-exposure prophylaxis study and on high-risk children. The post-exposure prophylaxis study tested the rate of virus transmission from an influenza virus-infected household member to Xofluza-treated household. The result found an arm treated with Xofluza significantly reduced the risk of people developing flu by 86 percent. Clinical trial MINISTONE confirmed positive effect of Xofluza, evaluating virus titer and the time to alleviation of symptoms on pediatric patients aged one to 12 with treatment of the flu treatment. Moreover, Xofluza is also currently calling for clinical trial participants for three other trials. One of the three trials is to study the treatment effect on infant patients under the age of one, whereas the second one titled FLAGSTONE is to observe arms treated with either Xofluza only or Xofluza and the standard of care Tamiflu together as a combination on hospitalized patients. The FLAGSTONE trial is designed to administer Xofluza once on day 1, day 4, and day 7, respectively, for three times total. CENTERSTONE, the last one out of the three trials, is to evaluate preventive effect of Xofluza on patient’s virus transmission. Unlike the post-exposure prophylaxis study, the third trial is to administer the treatment on the patient only and observe not only the patient’s time to alleviation of symptoms, but also the virus transmission among the patient’s household members. When the three trials complete with satisfying results, indications for Xofluza would expand remarkably. Professor Lee Jae-gab of Hallym University Medical Center Infectious Disease Department commented, “Besides the advantage of convenient one-dose oral administration, Xofluza is expected to be used for various indications as it has a different mechanism of action compared to other existing options”. Xofluza has been approved by Korea’s Ministry of Food and Drug Safety (MFDS) in November for treating adult and pediatric patients aged over 12 with Type A and B influenza infections.
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- The NHIS again urged to pay Valsartan damages by this month
- by Chon, Seung-Hyun Dec 24, 2019 06:10am
- Health authorities urged pharmaceutical companies to pay Valsartan claims. 36 pharmaceutical companies have already filed a lawsuit that they are not liable to pay preemptively, but have reaffirmed their willingness to collect the money. According to the industry on the 20th, the National Health Insurance Service recently issued a reminder to pharmaceutical companies to pay Valsartan compensation claims. The National Health Insurance Service requested to pay ₩2.03 billion in compensation to 69 pharmaceutical companies. After last year's outbreak of the impurity Valsartan’s issue, it is follow up by the Ministry of Health and Welfare that they will get back the amount of money invested in the drug to the patients for the remainder of the existing prescription. The National Health Insurance Service sent out a notice to pharmacy companies that did not pay the compensation and urged them to pay by October 31. But the payment rate was low, so they sent a second reminder this time. In fact, most large companies have refused to pay. According to the data submitted to In-sun Nam, a member of the Democratic Party of Korea, 26 pharmaceutical companies paid ₩440 million in compensation. The payment rate was only 21.5%. The drugmakers refused to pay about 80% of the recourse amount. The industry believes that companies that have not paid the bill so far are unlikely to pay. A legal battle with the health authorities has already become a reality. Pharmaceutical companies filed a debt existence verification lawsuit against the National Health Insurance Service in Seoul Central District Court on Nov 27th. It preemptively filed a lawsuit stating that it was not responsible for the Valsartan damages claimed by the National Health Insurance Service. Thirty-six pharmaceuticlas of the claims were filed. Originally, pharmaceutical companies considered ways to co-operate if the National Health Insurance Service filed a lawsuit for damages. However, they agreed to take a hard-line response by preemptively bringing up class action. Pharmaceutical companies are claiming that they are not responsible for Valsartan damages claimed by the government. Pharmaceutical companies stress that there are no manufacturing and design flaws with impurity Valsartan. Carcinogen N-nitrosodimethylamine (NDMA), detected in Valsartan issue, is a hazardous substance that has no standard in the Valsartan raw material. Neither governments nor pharmaceutical companies were aware of the risks of NDMA detection in Valsartan. According to the Product Liability Act, it is clear that if the manufacturer proves that the defect was not found at the level of science and technology at the time the manufacturer supplied the product, he would be liable for damages. After the Valsartan issue, the MFDS derived a test method for detecting NDMA from Valsartan raw materials and set new standards. The MFDS reviewed the guidelines recommended by the International Pharmaceutical Regulatory Harmonization Committee (ICH M7), domestic and international data, and expert advice to set the NDMA standard for Valsartan to 0.3 ppm or less. Pharmaceutical companies also hold the position that compensation claims made by the National Health Insurance Service are not included in liability. Pharmaceutical companies insist that there is no liability under the Product Liability Act for Valsartan consultation fee or dispensing fee.
- Company
- BMS loses the trial to revoke Eliquis’ 30% price cut
- by Kim, Jin-Gu Dec 24, 2019 06:09am
- Bristol-Myers Squibb (BMS) filed an administrative litigation to appeal against the government’s decision to lower pricing of new oral anticoagulant (NOAC) Eliquis (apixaban), but lost the case regardless. At a trial to revoke the Maximum Drug Reimbursement Price Adjustment order by the Minister of Health and Welfare on Dec. 19, Seoul Administrative Court has decided to dismiss the plaintiff, BMS’ appeal. The court also ordered the plaintiff to pay for the litigation cost. According to the court ruling, the Eliquis price reduction already postponed twice would be enforced soon. However, BMS has not confirmed their intention to file another appeal. The legal dispute between BMS and MOHW over lowering price of Eliquis actually started from a patent dispute. The Eliquis patent dispute began since March of 2015. Huons and other companies challenged Eliquis’ patent to invalidate it. The Patent Court, as a first trial, had decided that the drug patent is invalidated in February, 2018. The Korean companies won preferential sales approval by Ministry of Food and Drug Safety (MFDS) based on the invalidation ruling. Accordingly, apixaban generic was launched this June. With the generic entering the market, MOHW notified it would lower the maximum reimbursement price of the original Eliquis by 30 percent. The administrative measure was made based on the regulation stating the original’s maximum reimbursement price should be lowered, due to commercialization of its generic, by 30 percent in the first year and to 53.55 percent of the initial price from the following year. Therefore, the price of Eliquis was supposed to be lowered by 30 percent from 1,185 won per tablet to 830 won per tablet. However, BMS requested the Administrative Court to suspend the execution urging the ministry’s decision to lower the price was unfair. Simultaneously, the company officially filed for litigation against the administrative action to drop the drug pricing. The Seoul Administrative Court allowed BMS’ request on suspending the execution. The court stated the patent dispute over Eliquis has not been settled, yet, and the litigation to revoke drug price reduction is still ongoing, so the drug pricing reduction should be deferred until the final decision is made. While the BMS’ litigation was in process, price reduction on Eliquis has been postponed twice. MOHW then has decided to maintain the original’s initial pricing until Dec. 31 this year. Finally the last decision on the litigation has been made. But the Seoul Administrative Court that previously accepted BMS’ request to suspend the execution made a contrasting decision during the litigation case. Experts see that the Supreme Court invalidating Elquis’ patent in October has played the key role in the decision. The Supreme Court reaffirmed the first and second trial ruling by the Intellectual Property Trial and Appeal Board and the Patent Court, respectively, and ruled for the generic manufacturers. A legal expert elaborated, “The judge made a polarizing decision for the litigation case than for the suspension of execution trial. Whether or not the judge would quote the suspension of execution trial is not to base on the legality of the plaintiff’s claim, but on the predicted loss and the grounds of litigation.”
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- No more patent-evading IMD, needs new strategies
- by Kim, Jin-Gu Dec 23, 2019 06:29am
- Technically, the days of Korean pharmaceutical companies evading drug patent infringement by modifying the original’s salt base are over. The Supreme Court’s ruling on the solifenacin (trade name: Vesicare) case in the beginning of the year first showed the signs of ending drug patent infringement with incrementally modified drug (IMD). And it was reaffirmed on Dec. 20 with the Patent Court’s ruling for varenicline (trade name: Champix). As for Korean companies, the time has come to seek for other strategy to challenge patent. Experts say it would be more difficult than the old IMD strategy, but it is not say there isn’t any other way to challenge patent. The other feasible strategy is to file an invalidation trial for each item to challenge the accusation of patent infringement. Popular IMD strategy has become a thing of the past Pharmaceutical industry and legal experts say the Champix ruling was actually “expected”. The majority of the experts predicted the solifenacin case would set a new precedent. Only a handful of experts claimed the Supreme Court left a room for interpretation on the patent’s ‘practical equivalence’ and ‘technical obviousness of Person Having Ordinary Skill in the Art (PHOSITA)’. Ultimately, judges made same decisions on following Januvia, Pradaxa, and Champix cases and reaffirmed the Supreme Court’s decision. In August and September, the Patent Court ruled favorably for the original patentee of Pradaxa and Januvia, respectively, against IMDs. Even in last year, IMD with switch in saline base has been the most common strategy for Korean companies to evade patent infringement and launch their generic early. Hanmi Pharmaceutical’s Amodipin is a typical case. By incrementally modifying Pfizer’s Norvasc in 2004, Hanmi Pharmaceutical has been generating tens of billions of won annually after commercializing the antihypertensive amlodipine generic. The first alert went off when the original manufacturer, Astellas Pharma had requested litigation for cancellation of a trial decision on solifenacin IMD to the Patent Court in 2016. Korean companies switched out succinate of the original solifenacin drug with fumarate. The Patent Court recognized two combinations as different substances, and decided that solifenacin fumarate does not infringe the extended patent period. However, the Supreme Court said the otherwise. Following the court’s ruling, lower courts made a series of similar decisions and put the IMD strategy on shaky ground. Pipeline strategy to change inevitably, then how about the originals? Experts predict about 150 IMDs challenging respective patents would end up with similar ruling as the precedents. Accordingly, Korean companies now have no choice but to shift pipeline strategy. The time has come to let go of IMD, the relatively convenient option of evading patent infringement. Considering medium-sized pharmaceutical companies challenged patents with IMDs, the intangible loss for giving up on IMD is expected to be significant. Moreover, the original’s companies could start a domino of litigations. Based on the precedents, the original companies are highly likely to file damage suit against IMDs for infringing their patents. Since the overruling the previous solifenacin decision, Pfizer has requested for an injunction to ban sales of incrementally modified solifenacin, and the court has accepted the request. Other original companies have not been reported to have requested the injunction. The industry is keenly paying an attention on whether or not Pfizer would file the damage suit. The legal experts see that the case would probably be favorable to Pfizer quoting the Supreme and Patent Courts’ decisions and Seoul Central District Court’s injunction. Seeking for other options to challenge drug patent The industry-changing court ruling aside, it’s not to say Korean companies’ patent challenge is absolutely impossible from now on. The patent system can be bypassed. The Patent Court’s ruling on Betmiga (mirabegron) made a day before Champix case is a good example. At the Patent Court on Dec. 18, 11 Korean companies, including Hanmi Pharmaceutical, Chong Kun Dang Pharmaceutical, JW Pharmaceutical, Ildong Pharmaceutical, Intro Biopharma, Alvogen Korea, Kyung Dong Pharm, Shinil Pharmaceutical, Han Wha Pharma and Shin Poong Pharmaceutical won the patent dispute against original company Astellas Pharma. Meanwhile, Korean pharmaceutical companies are apparently trying new patent challenge strategies. The existing IMD strategy was based on defensive confirmation trial for scope of a patent, which means it was challenging a small part of a whole patent. Incremental modification of saline base was meant to challenge a part of extended period of drug patent. On the other hand, the Korean companies filed an invalidation trial instead to challenge the patent. If they win, the trial would nullify not partial, but the whole patent. However, the trial is not to challenge drug patent, but to challenge novel use patent. In other cases, some have challenged the extended period of drug patent with invalidation trial. Hanmi Pharmaceutical and Ahn-gook Pharmaceutical won the invalidation trial against Novartis’ DPP-4 class diabetic treatment Galvus in last February. The two companies have successfully revoked validity of the extend patent on Galvus. A legal expert commented, “More than the Champix’ case, Betmiga’s trial attracted more attention as it was unpredictable. Invalidation trial is surely complicated, but it is not impossible”. “Defensively confirming the scope of a patent is now useless only for IMD, but other option could be used to challenge drug patents”, the legal expert added.
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- Ulcerative colitis added to Stelara's domestic indications
- by Eo, Yun-Ho Dec 23, 2019 06:29am
- Janssen's interleukin-12/23 (IL-12/23) inhibitor 'Stelara' can be prescribed for ulcerative colitis. According to the industry, the KFDS recently approved Janssen's Stelara (Ustekinumab) as a treatment for moderate to severe adult active ulcerative colitis. As a result, Stelara has acquired four indications in Korea, including ulcerative colitis, plaque psoriasis, psoriatic arthritis, and Crohn's disease. The expansion of Stelara's ulcerative colitis indications was based on the UNIFI program, Phase III. The program consisted of one maintenance therapy with subcutaneous injection every 8 weeks for 44 weeks after one initial induction study with a single intravenous injection of Stelara. The study found that 19% of Stellar dose groups reached clinical remission in 8 weeks and 58% of patients responded. In maintenance studies, 44% showed improved tissue endoscopic mucosal membranes after one year. Meanwhile, starting with Stelara in the interleukin therapeutic market, four items are approved including ▲IL-17's Cosentynx (Secukinumab) by Novartis, ▲Lilly's Taltz (Ixekizumab), ▲IL-23 Inhibitor, Tremfya (Guselkumab). In addition, Boehringer Ingelheim is conducting a global phase III study comparing the IL-23 inhibitor 'BI655066' with Stelara, and Brodalumab, developed by AstraZeneca, has also been shown to be effective in direct comparison with Stelara and has been approved in Europe.
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- Drug trade volume to hit all-time high over USD 10 bln
- by Kim, Jin-Gu Dec 22, 2019 09:51pm
- Korea’s accumulated trade volume is expected to surpass USD 10 billion for the first time. The biggest impact is from a significant surge of pharmaceutical export volume. This year’s overall pharmaceutical export volume is projected to go over 3.6 billion dollars. The number almost doubled, compared to four years ago in 2015. According to statistic data from Korea Customs Service, the accumulated pharmaceutical trade volume, as of November, reached 9.34 billion dollars (approximately 10.91 trillion won). If the trend continues, the pharmaceutical trade volume from this year alone is expected to surpass the 10 billion-dollar mark for the first time. Pharmaceutical import and export volume by year. 2019 includes projected December figure based on performance as of November. (Source: Korea Customs Service) In recent years, the trade volume grew constantly reaching 6.27 billion dollars, 7.44 billion dollars, 7.94 billion dollars, and 9.37 billion dollars in years from 2015 to 2018, respectively. The pharmaceutical export volume had the biggest surge. As of November, the pharmaceutical export volume reached 3.34 billion dollars (approximately 3.91 trillion won). Outperforming last year’s export volume at 3.27 billion dollars, this year’s volume is expected to easily make over 3.6 billion dollars by the end of the year, hitting the highest point in the history. The all-time high export volume was possible this year due to strong performance from Celltrion and Samsung Biologics’ biosimilars and Daewoong Pharmaceutical’s Nabota export. Moreover, the government building stronger ties with Southeast Asian countries have helped the increase in export to their markets. On the other hand, pharmaceutical import volume has reached 5.99 billion dollars as of November (approximately 7.32 trillion won). The trade surplus, balancing export and import volumes, is to get better by a bit. Last year’s pharmaceutical trade made a deficit of 2.83 billion dollars. This year’s deficit is expected to be around the similar level of 2.8 billion dollars. Pharmaceutical import and export volume from January to November, 2019. (Source: Korea Customs Service) Apparently, Korea’s overall trade volume has surpassed one trillion dollars this year. The trade volumes in last three years have exceeded one trillion-dollar mark since 2017. China, the U.S., Germany, Japan, the Netherlands, France, the U.K. Hong Kong and Italy as well as Korea are the only ten countries around the world to have overall trade volume over one trillion dollars.
