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- 2026-05-20 12:30:52
- Company
- Keytruda to finally get Cancer Committee nod after 2years?
- by Eo, Yun-Ho Apr 24, 2020 06:27am
- After waiting for two long years, MSD is committed to receive the Korean health authority’s approval on Keytruda’s coverage expansion this time. According to pharmaceutical industry sources, the Health Insurance Review and Assessment Service (HIRA) Cancer Deliberation Committee’s deliberation on Keytruda (pembrolizumab) has been scheduled on Apr. 29 after it has been delayed twice due to the COVID-19 outbreak. Although the deliberation would review Keytruda’s reimbursement expansion on the added indication as a first-line treatment (monotherapy and combination therapy) for non-small cell lung cancer (NSCLC), MSD has reportedly submitted related economic evaluation data. For a reimbursement expansion case, the committee assesses financial impact but it does not ask for a submission of economic evaluation data. In March 2017, Keytruda monotherapy has been approved as a first-line treatment in patients with NSCLC. And the MSD Korea has submitted an application for reimbursement approval on the monotherapy indication in September 2017 and continued to talk with the government for over two years. Regardless of the effort, the talks fell through in September last year. And in October last year, MSD Korea has reapplied for reimbursement expansion on Keytruda’s five indications including pembrolizumab monotherapy and combination therapy as first-line treatment in NSCLC, monotherapy as second or later-line treatment in bladder cancer, and monotherapy for third or later-line treatment in or refractory classical Hodgkin lymphoma. So far at the broken off talks with the government, key issues like conditionally limiting the reimbursement to ‘patients showing response to the treatment,’ and ‘the trade-off (a government initiative to recognize the value of new drug while compensating the cost with reduced pricing of off-patent drugs)’ were addressed. MSD’s desperation is also apparent on the negotiating table due to the long wait. Prior to the coming deliberation, MSD has reportedly expressed its intention to accept the government’s proposal on sharing financial burden of expanded reimbursement by lowering drug pricing. The global company official stated, “Over the span of two years, the company has been negotiating and narrowing the gap with the government over expanding Keytruda’s reimbursement, and we think the two parties have been engaged enough to have better understanding of each other. Based on the experience, the company is making sure to receive the expanded reimbursement this time.” The National Comprehensive Cancer Network (NCCN) guideline has added pembrolizumab plus chemotherapy combination therapy as a Category 1 first-line treatment in all patients with metastatic NSCLC, which is also listed as preferred. The pembrolizumab monotherapy is also listed as preferred for first-line therapy in patients with positive PD-L1 expression over 50 percent.
- Policy
- Chong Kun Dang’s Esoduo, registered additional patents
- by Lee, Tak-Sun Apr 24, 2020 06:26am
- Chong Kun Dang’s anti-ulcer agent Esoduo (Esomeprazole magnesium trihydrate), has added an additional patent. Basically, if the original drug patent is listed on the MFDS’ patent list, late candidates must succeed in the patent challenge to ensure early release. Items that are commercially available without patent challenge may be subject to prohibition. On the 22nd, Chong Kun Dang registered a new composition patent (stable pharmaceutical composition including Esomeprazole and Sod. hydrogen carbonate) for Esoduo in the MFDS patent list. This patent expires on January 29, 2038, like the previously listed formulation patents (pharmaceutical formulations including Esomeprazole and Sod. hydrogen carbonate). As soon as it was registered on November 1, last year, Daewon Pharm, CTC Bio, Ajou, and Shinil filed a judgment to confirm the passive scope of rights to evade patents. Among them, Daewon has already been approved for bioequivalence test for generic commercialization in April of last year, and Ajou has been approved for development in October of that year. Chong Kun Dang's addition of this patent is interpreted as a measure to further strengthen the defense. This is because if latecomers want to release the generic drug early before the patent term expires, it must succeed in the patent challenge. Otherwise, if Chong Kun Dang enforces the launch, it may be prohibited from selling by a patent holder for a certain period (9 months) by the patent-linkage system . Conversely, it can be a burden for patent infringement lawsuits. Esoduo is a new drug to improve GERD released in July 2018. It is the first compound in the country to combine the PPI-based component Esomeprazole and Sod. hydrogen carbonate, which rapidly raises the hydrogen ion index (pH) in the stomach to protect the Esomeprazole component that is weak to stomach acid and takes a long time to act and protect the drug from stomach acid. After the drug is absorbed from the upper duodenum, the efficacy of the drug quickly appears. Last year, the outpatient prescription amounted to ₩9.8 billion, which is the target of late starters as it recorded sales close to blockbusters in two years after launch. In the future, attention is being paid to Chong Kun Dang, which is defending in advance, and latecomers who are promoting the early launch of generic drugs.
- Company
- The KPBMA promotes of co-development of COVID-19 treatments
- by Lee, Seok-Jun Apr 24, 2020 06:26am
- The KPBMA promotes joint development of COVID-19 treatment. This is the first 'co-investment and joint development' method among member companies. The KPBMA held a board of directors meeting on the 21st to discuss this. Participants decided to aggregate their competencies at the industrial level, not individual companies, based on the prospects of domestic and foreign experts that another COVID-19 outbreak would occur frequently. In addition, they considered ways to establish joint ventures with co-investments by companies and to establish private and public joint funds such as the European IMI (Innovative Medicines Organization). In the future, if the KPBMA materializes joint investment and joint development plans through consultation with related experts, the industry will actively participate. An association official said that the joint R&D situation among member companies for developing new drugs is more mature than ever before, and they agreed that it is necessary to change the concept of sharing profits if profits arise and sharing risks if they fail for new drugs. Chairman Hee-mok Won emphasized, "In order to overcome a crisis that can be repeated in the future, such as COVID-19, a revolutionary idea change is needed. The cross-border energy with joint research and development efforts of the industry and full support from the government must be brought together."
- Policy
- Betmiga's first generic, Hemlibra registered next month
- by Kim, Jung-Ju Apr 24, 2020 06:26am
- 2 items including Mirabeg 50mg, which are the first generic drugs for overactive bladder, and Hemlibra 30mg for hemophilia treatment (Emicizumab) by JW Pharmaceutical are confirmed to be registered next month, and are added to the drug benefit standard. In addition, oral administration of Clopidogrel is acceptable for children with Kawasaki disease who have exceeded the permit. The MOHW announced an administrative amendment on the 20th of the notice regarding ‘the Pharmaceutical Reimbursement Listing Standard and Method’ and entered the opinion inquiry until the 24th. As for the revised contents, two items, such as Mirabeg 50mg, which is an overactive bladder treatment drug, will be registered next month, the standards for insurance benefits is to be applied from the 4th of next month. Also, on the first day of next month, Hemlibra 30mg (Emicizumab), which is scheduled to be registered in patients with severe type A hemophilia with the factor 8 antibody, is recognized for up to 24 weeks. In principle, this drug is administered in-hospital at a medical institution that meets the requirements for an immunotolerance regime for safe administration. The subject to be administered is a severe hemophilia A patient with an 8th factor antibody (coagulant activity is less than 1%). ▲Over 12 years of age, weight over 40kg ▲Antibody titer has a history of 5BU (Bethesda unit)/mL or more ▲In case of bleeding in 6 or more times in the last 24 weeks, a bypass factor was administered or immunotolerance therapy failed should all be satisfied. Children with Kawasaki disease exceeding the permitted range of use will be admitted to take Clopidogrel which are Pregrel, Provic, Clovid, and Clopin. The subjects to be administered are children under 18 years of age diagnosed with Kawasaki disease. Monotherapy is applied when there are side effects or contraindications to Aspirin, and in the case of a second-line therapy (Aspirin + Clopidogrel), warfarin cannot be administered as a patient with coronary aneurysm with a diameter of more than 5 mm and less than 8 mm with a risk of thrombosis ( Hypersensitivity or contraindications to warfarin, failure to adjust the International Normalized Ratio (INR), etc.). The third-therapy regimen (Aspirin + anticoagulant + Clopidogrel) is for patients with a large aneurysm greater than 8 mm in diameter with a history of coronary thrombosis within the last 6 months. The age-related permission for Protopic ointment 0.1%, 0.03%, etc. (Tacrolimus) have been changed from 2 years old to 2 years old in full. Considering the anemia standard of iron injections such as Venoferrum and the characteristics of pregnant women, the standard of hemoglobin, serum ferritin, and transferrin saturation is relaxed to expand the standard for insurance coverage.. Hemoglobin levels change from the current 8g/dl to 10g/dL (but 11g / dL for pregnant women). Considering the anemia standard of iron injections such as Venoferrum and the characteristics of pregnant women, the criteria for hemoglobin, serum ferritin, and transferrin saturation are relaxed to expand the standard for insurance coverage. Hemoglobin levels change from the current 8g/dl to 10g/dL (but 11g/dL for pregnant women). Liquid iron preparations, such as Hemocom, also expand the benefits by relaxing the standards of hemoglobin levels, serum ferritin, and transferrin saturation as primary drugs in accordance with the expansion of the iron injection system. It is specified in the individual notice so that it is not administered at the same time or concurrently with sodium hyaluronate preparations accordance with the reimbursement standard (positive reimbursement) for the treatment material for injection in the knee joint, such as chondroid In addition, as two items of Fattiodol injection to be used for carotid artery embolization of liver cancer are scheduled to be listed from next month, the supplement is recognized by adding 'etc.' to the names of ethyl esters of the iodised fatty acids of poppyseed oil injections such as Lipiodol Ultra Liquid, and the reimbursement is recognized. As eight items, including Movizolo 1 mg are scheduled to be listed, the benefit is recognized by adding 'etc.' to the name of the oral product of Prucalopride succinate.
- Company
- Amid COVID-19, March drug export hits record high
- by Kim, Jin-Gu Apr 24, 2020 06:26am
- A monthly export volume of Korean pharmaceuticals has reached a record high in last March. Sources view the COVID-19 outbreak has not affected the pharmaceutical production and export significantly. According to the import and export statistics data published by Korea Customs Service (KCS), Korea has exported USD 538.09 million (approximately 660.2 billion won) worth of pharmaceuticals in March. The Korean-made pharmaceutical export volume has gone up by 51.3 percent, compared to March 2019 at 356.52 million dollars (approximately 437.1 billion won). Also, the volume increased by 51.3 percent as well only in a month from February (355.57 million dollars) to March 2020. Korean pharmaceutical volume in March 2020 has marked the record high (Unit: USD 1,000) Source: KSS In the same period, the import volume has also reached the highest in the history at 688.78 million dollars (approximately 845.1 billion won). Compared to the year before, the volume was increased by 27.5 percent from 540.36 million dollars (approximately 663.0 billion won). The huge surge in export volume has noticeably improved the pharmaceutical trade balance. In March, Korea has made trade deficit of 120.69 million dollars. Compared to the two months last year, the deficit figure was reduced by 18.0 percent. However, the overall export volume in Korea has gone down by 0.7 percent from 47.03 billion dollars to 46.69 billion dollars in the same period. This is why the pharmaceutical export volume has emerged as the highlight of the month. The COVID-19 outbreak does not seem to have directly affected production or export of pharmaceuticals in Korea. ◆Export to Germany and Japan soars, when export to the U.S. and China drops Sorting by country, the export to Germany and Japan has significantly increased. On the other hand, the export to the U.S. and China has diminished. In March alone, the exports to Germany have generated 164.42 million dollars. The figure has tripled from 48.19 million dollars in the year before. More specifically, the exports to Germany exceeded last December’s record high volume at 112 million dollars. The exports to Japan soared by 53.5 percent in March at 28.33 million dollars, compared to 18.45 million dollars last year. Meanwhile, the volume exported to the U.S. has been decreased by 16.3 percent than the previous year at 64.11 million dollars. And the export volume to China in the same month has plunged by 26.0 percent from 24.44 million dollars last year to 18.58 million dollars this year. Trend in export volume with major pharmaceutical trading countries (Unit: USD 1,000) Source: KSS) The pharmaceutical ingredient distribution issues in China and India that the industry insiders were concerned about does not seem to have surfaced in the export statistics. On the contrary, the Chinese and Indian-made pharmaceutical import volumes have rather increased than the year before. 90 percent of pharmaceutical active ingredients are currently imported from China and India. Korea has been importing pharmaceuticals from China, which the volume has grown by 33.8 percent from 7.52 million dollars in March last year to 10.06 million dollars in March this year. Comparing the figure in March to February at 7.53 million dollars, the volume has gone up by 33.5 percent. The pharmaceutical import from India has reached 5.64 million dollars in March. Compared to the year before at 4.91 million dollars, the volume was increased by 14.9 percent, but compared to Febraury at 1.95 million dollars, the March figure has skyrocketed by 189.5 percent.
- Company
- General hospitals to prescribe obesity drug Qsymia
- by Eo, Yun-Ho Apr 23, 2020 06:27am
- Gaining popularity in the obesity treatment market, Qsymia has entered its prescription code in Korean general hospitals. According to pharmaceutical industry, Qsymia (phentermine hydrochloride plus topiramate), co-marketed by Alvogen Korea and Chong Kun Dang, has been recently passed by Drug Committees at the Big Fives including Severance Hospital and Seoul Asan Medical Center and other major institutes like Korea University Anam Hospital and Ajou University Hospital. Qsymia is available in four doses (3.75 mg/ 23 mg, 7.5 mg/ 46 mg, 11.25 mg/ 69mg, and 15mg/ 92mg) at a price of 4,000 won. The daily costs of Belviq, Contrav and Qsymia are about the same in Korea and the U.S. A clinical study on the drug has found Qsymia, compared to other FDA-approved long-term prescribed obesity treatments, demonstrated the most effective weight loss benefit and confirmed safety profile better than Saxenda and Contrav. The study conducted a retrospective meta-analysis on five weight loss medications, which analyzed 28 randomized clinical trials with 29,018 participants. Qsymia showed the highest efficacy in losing more than 5 percent of a person’s body weight, which Saxenda, Contrav, Belviq and Xenical followed after in the order. 54 percent, 34 percent, 30 percent, 25 percent and 20 percent of participants who were administered with Qsymia, Saxenda, Contrav, Belviq and Xenical, respectively, lost more than 10 percent of their body weight. Saxenda and Contrav had the highest risk of adverse reaction, while Belviq had the lowest. Qsymia’s risk in adverse reaction was about in the middle between Saxenda and Belviq. According to data published by UBIST, 310 million won and 614 million won worth of Qsymia were prescribed in last January and February, respectively. The drug’s prescription volume in February followed after Saxenda (875 million won), Dietamin (847 million won) and Hutermin (780 million won) in the market.
- Policy
- Chong Kun Dang's own brand botulinum sales countdown
- by Lee, Tak-Sun Apr 23, 2020 06:27am
- Chong Kun Dang's anti-wrinkle agent botulinum toxin will be released to the market soon after receiving national lot release. In the meantime, Chong Kun Dang has been selling Hugel's brand 'Botulax', but it ended the contract last year and prepared to sell its own brand. According to the industry on the 22nd, Chong Kun Dang secured the rights of the botulinum toxin formulation 'Wondertox 100 units' (Clostridium botulinum toxin type A) through the transfer with Huons at the end of last year. Wondertox was approved by Huons in August of last year, but the rights were transferred to Chong Kun Dang through the transfer. Instead, production is undertaken by Huons Global, a holding company. Huons Global has a separate botulinum formulation 'Liztox' (Export name: Hutox). National lot release is a system that approves sales after conducting data screening and tests for vaccines, botulinum preparations, and plasma fraction preparations. National lot release means that it can be sold on the market. As soon as Wondertox passed final step, it is expected to start selling through the hospital soon. The reason for interest in Chong Kun Dang's botulinum toxin is that Chong Kun Dang previously collaborated with Hugel to sell botulinum toxin 'Botulax', which significantly increased its market share. Since 2014, Chong Kun Dang has signed a joint sales contract for 'Botulax' with Hugel and has been selling products until June of last year. With the sale of Chong Kun Dang, Botulax won the market by surpassing Medytox with sales of about ₩50 billion in the domestic market. This is the result of taking full advantage of Chong Kun Dang's largest sales force, the largest in Korea. Sale for Botulax ended, but Chong Kun Dang gained sales experience instead. As a result, Wondertox is expecting to settle in the market early through sales staffs who have accumulated sales experience. Moreover, Medytoxin by Medytox, which had a predominant sales rate, was banned due to suspicion of manipulation. Taking advantage of this, Wondertox was able to expand its customers. The participation of Chong Kun Dang and the ban on the sale of Medytox is expected to change the market for the domestic botulinum toxin market. It is noted who will be the final winner in the domestic market worth about ₩100 billion.
- Policy
- Atnahs is insisting on infringement against generics
- by Lee, Tak-Sun Apr 23, 2020 06:26am
- Generic for Bonviva , an osteoporosis treatment drug launched in 2012, was lately caught up in a patent dispute. This is because the changed patent holder is insisting on infringement of indications and dosage patents against generics. According to the industry on the 21st, Atnahs, UK, which took over the patent right of Bonviva from Roche in 2018, filed a lawsuit against patent infringement in domestic generic company A. It is known that the patent infringement lawsuit is still ongoing. In response, domestic pharmaceutical companies have also filed a patent invalidation trial since March. Following the first judgment on March 10 by Theragen Etex, Cho-A Pharm, Wooridul Pharmaceutical, Arlico Pharmaceutical, Kolmar Korea, Huvist, Ildong Pharmaceutical, Hana Pharmaceutical, and Hyundai Pharmaceutical joined. An official at a pharmaceutical company that filed patent invalidity said that he claimed alleged patent infringement against generic company A because the new patent holder filed a patent invalidation lawsuit. This patent relates to indications and dosage of Bonviva. It is for taking 150mg once a day at least 1 hour before eating food in the morning. In Korea, the advancing indications and dosage patents are not recognized, but in the 2015 Supreme Court agreement, they are recognized as a new component of the invention of medical use. At the time of the release of generics in 2012, indications and dosage patents were not a problem for market sales. Earlier, the official said that when launching generics, it was obvious that indications and dosage patent would be invalidated, but it was in the dispute after acknowledging the patent in Korea. Currently, there are about 40 pharmaceutical companies that have the same ingredients (Ibandronate Sod.) generics such as Bonviva. Therefore, it is an analysis that the direction of patent invalidation judgment is important. Currently, Bonviva has a domestic copyright in Roche. The amount of outpatient prescriptions (Souce: UBIST) last year was ₩2.8 billion.
- Company
- Global companies made KRW 21M per employee last year
- by An, Kyung-Jin Apr 23, 2020 06:26am
- Korea Otsuka Pharmaceutical has generated the highest operating profit per employee last year among Korean branches of multinational pharmaceutical companies. Each employee at the multinational company has made 108 million won worth of operating profit. On Apr. 21, an analysis on 30 multinational pharmaceutical companies in Korea surveyed audit reports submitted to the Financial Supervisory Service (FSS) and found the companies operating profit per employee. Last year’s operating profit per employee in top multinational pharmaceutical companies (Unit: KRW 1 million) Source: FSS Last year, 30 Korean branches of multinational pharmaceutical companies have generated overall operating profit of 115.8 billion won with total 5,620 employees. Basically, respective employee has made average of 21 million won worth of operating profit, which is 10 million won less than in 2018 with 31 million won. Operating profit per employee in multinational companies in Korea is approximately a half of the figure in Korean pharmaceutical and bio companies. According to Daily Pharm’s survey on 30 companies with highest sales last year based on their business reports, each employee has generated average operating profit of 36.98 million won. Fundamentally, the pharmaceutical industry is considered as an industry with comparatively low operating profit. Its investment scale is exponential with R&D and sophisticated facilities, and the industry is actually labor-intensive with strong sales force. And Korean affiliates of multinational pharmaceutical companies have unique structure of supplying finished pharmaceutical product from overseas headquarters, which sometimes lowers profitability against sales volume due to high total cost of goods sold. Moreover, the profitability of many multinational companies in Korea is diminishing after their blockbuster drugs’ patents have expired, which also seems to have reduced operating profit per employee. Among the surveyed companies, only Korea Otsuka Pharmaceutical has made over 100 million won operating profit per employee. 357 employees of the multinational company combined have reached operating profit of 38.5 billion won. It adds to making operating profit of 108 million won per employee. Although the company’s healthcare product sales has been impacted by the Koreans boycotting Japanese goods, Korea Ostuka Pharmaceutical’s prescription drug sales has soared. First time since its establishment in Korea, its sales has marked 180 billion won and the operating profit was increased by 23.0 percent than the previous year. Korea Otsuka Pharmaceutical is one of a few multinational pharmaceutical companies with its own manufacturing facility in Korea. When Janssen Korea closes a plant in Hyangnam City, Korea Otsuka Pharmaceutical’s facility in Hyangnam City and Janssen Korea’s vaccine manufacturing plant in Songdo Bio Cluster would be the only two pharmaceutical manufacturing facilities in Korea owned by multinational companies. Generating 91 million won per employee last year, UCB Korea was ranked on the second place. As of late last year, the company reported the total number of employees was 36. Although the operating profit has gone down by 8.4 percent (30 million won) compared to 35.88 million won in 2018, UCB Korea has continued to make surplus with a limited number of employees and maintained the relatively higher productivity. Stuck in the reds for three consecutive years, GlaxoSmithKline (GSK) has turned around and finally generated surplus last year and made 18 million won per employee. The operating profit per employee in AbbVie Korea, Janssen Korea, Sanofi Pasteur, Allergan Korea and Guerbet Korea has grown by over 10 million won last year compared to the previous year. On the other hand, Alcon Korea has made operating profit of 2 million won per employee last year, not even reaching 10 million won. Menarini Korea, Janssen Vaccines, Galderma Korea, Roche Korea and Merck KGaA have ended up making deficit last year. Excluding the companies in the reds, 11 out of 23 surveyed companies have made operating profit per employee last year lower than the year before. In 2018, Sandoz Korea marked the highest operating profit per employee with 178 million won, but the figure plummeted last year and marked 31 million won per employee. Plunged by approximately 40 million won from 112 million won in 2018, Kyowa Kirin Korea has only made 74 million won operating profit per employee last year. As for Genzyme Korea, the operating profit in 2018 was at 62 million won per employee, but the last year’s figure was omitted from the report due to the merge with Sanofi-Aventis.
- Policy
- Samsung developed mobile blood pressure measurement app
- by Lee, Tak-Sun Apr 23, 2020 06:26am
- The MFDS (Chief Lee Eui-kyung) announced on the 20th that it approved the world's first software as a medical device (SaMD) that measures blood pressure using a 'mobile app'. This medical device is a 'blood pressure app' developed by 'Samsung Electronics Co., Ltd.'. It measures blood pressure easily by using a smart watch (mobile platform) on the wrist without wearing a cuff on the arm, and provides the user with a systolic/dilatolic blood pressure of the heart, and pulse rate reporting software. In particular, the MFDS explained that it satisfies both the blood pressure and pulse rate accuracy standards, which are the performance standards for medical devices of conventional automatic electronic blood pressure monitors. In order to promote the development of cutting-edge software medical device products, the MFDS held a round-table conference with mobile app companies in January of this year, listening to domestic and foreign product development trends and regulatory improvement needs. In February, the guidelines for safety management of mobile medical apps were revised so that only mobile apps can be authorized without permission for devices and devices used as mobile platforms, such as smartphones and tablet PCs. An official from the MFDS said that it expects the development of mobile platform-based software medical devices to become more active in the 4th industrial era, and will continue to support the rapid commercialization of medical devices with advanced technologies.
