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- 2026-05-14 17:09:37
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- MSD received administrative disposition for packaging
- by Whang, hyung-woo Jan 12, 2021 06:19am
- MSD Korea has been subject to administrative disposition for violating the provisions of supplying small packages. However, it was confirmed that they were looking for a way through the exception. Considering the characteristics of taking 2 tablets a day, it applied for relief saying that it had to admit an exception to the packaging of 60 tablets. However, there are many opinions that time is imminent as the import suspension measures for the item will proceed from next week immediately. #The MFDS imposed administrative measures to suspend manufacturing and import operations for pharmaceutical companies that violate the regulations on supplying small quantities of medicines in small quantities. MSD Korea was found to violate Article 42 of the Pharmaceutical Affairs Law due to the lack of standards for supplying small quantities of medicines in 2019, two items, Isentress (Raltegravir) and Isentress HD (Raltegravir, potassium micronized). According to the supply regulations related to package packaging for pharmaceuticals, manufacturers must supply 10% of the annual manufacturing/import volume for each item. However, if there is little data or product demand on inventory and disposal, the ratio can be set lower than 10%. In the case of MSD, it violated the regulation of 30 tablets packaging. Accordingly, the drug cannot be imported into Korea from January 15 to February 14. In the case of a violation of the current regulations on supplying small-sized packaging units, an administrative disposition for one month of suspension of the manufacturing business is applied, and in the case of the second violation, a three-month suspension of manufacturing business is imposed. However, MSD is planning to receive an exception to the regulation of the small package as both Isentress (Raltegravir) and Isentress HD (Raltegravir, potassium micronized) have characteristics of dosage. The dosage of Isentress published on the MSD official website is 400mg twice a day in combination with other antiretroviral drugs for the treatment of adult patients infected with HIV-1 on an adult basis. According to the current regulations, the two products must be packaged in a small package of 30 tablets or less, but the related product is characterized by taking 2 tablets a day, so it will be recognized that there is only one packaging unit of 60 tablets. MSD noted that it is in the process of being reviewed with relevant data submitted to the MFDS in order to obtain an exception. An MSD official said, "We have submitted data to receive exceptions considering the dosage of the product. The package of 60 tablets should be accepted as an exception considering the dosage characteristics of the drug." However, the time is imminent in that the administrative disposition procedure will start from the 15th, apart from the review of the MFDS. An MSD official said, "As a result of the current analysis, the problem in supply and demand of medicines due to import suspension is expected to be negligible."
- Company
- HK inno.N wins big in huge shift of global vaccine licenses
- by Kim, Jin-Gu Jan 11, 2021 06:11am
- Started from late last year, the massive shift in South Korean market sales rights over global vaccines has come to an end. Global companies like MSD, GSK and Sanofi Pasteur, and South Korean companies like GC Pharma, SK Bioscience, HK inno.N, Yuhan Corporation and Handok were involved in the mass migration of the businesses. The industry sees that HK inno.N took the biggest piece of the pie during the process. SK Bioscience letting go of one deal and taking another was also evaluated to have defended its position successfully. Also Handok was able to maintain its deals. However, GC Pharma and Yuhan are to minimize their loss of losing existing deals by concentrating on other items. ◆HK inno.N embraces deals worth 140 billion won as MSD entrusts all seven vaccines On Jan. 6, SK Bioscience announced it inked the co-marketing contract over five types of GSK vaccines. The announcement marked the end of global vaccine sales license migration in the South Korean market started since late last year. HK inno.N is supposedly the biggest winner of the shift that lasted three months. The Korean company signed the co-marketing and distribution contracts for seven of MSD vaccines in last November. Initially, GC Pharma had three of the deals and SK Bioscience had four of them, but all of them were transferred to HK inno.N. The pharmaceutical market research firm IQVIA says the seven MSD vaccine generated 141.5 billion won in last one year (Q4 2019 through Q3 2020). As a result, HK inno.N is to make 140 billion won more from this year on. ◆SK to fill up the 30 billion won loss from MSD vaccine deals with GSK vaccines The industry views SK Bioscience has done a good job compensating the damage of losing four MSD vaccines with five new GSK vaccine deals. Although HK inno.N took over four MSD vaccine contracts from SK Bioscience in last November, the company actually nabbed five of GSK vaccine deals early this year. When the previous four vaccines used to make 31.4 billion won annually, the new five vaccines would make 26.2 billion won. The simple math may indicate an immediate loss, but the increase in vaccine types could mean potential growth through strengthened sales strategy. Also the five adult vaccines by GSK could create synergy effect with the Korean company’s vaccines, Sky Zoster (varicella virus vaccine) and Sky Cellflu (influenza vaccine). ◆Handok and Sanofi extend co-promotion contract valued at 20 billion won annually Handok was able to successfully defend all existing deals with Sanofi Pasteur. In May 2019, Handok sealed the deals with Sanofi Pasteur on co-promoting six vaccines. The deals expired late last year, but the two companies have agreed to extend the terms before the expiration. The details of the extension have not been disclosed. The six vaccines have generated 21.6 billion won in last 12 months. Handok is to keep the annual income for this year. ◆Yuhan and GC lose sales licenses in South Korea, “Concentrating more on our own" Meanwhile, Yuhan Corporation and GC Pharm ended their vaccine deals with GSK and MSD during their contract extension negotiation. The damage of losing Zostavax and Gardasil would cost GC Pharma 110 billion won a year. Yuhan would also miss out on 20 billion won a year due to the terminated contract. The two companies plan to focus on their own products to minimize the loss. Specifically, Yuhan’s focal point would be on a lung cancer treatment lazertinib expected to receive conditional approval in the first quarter. The company has already hired anticancer sales people for the new business. GC Pharma is to also keep itself busy with its own influenza and varicella virus vaccine sales. Apparently, GC Flu’s last year sales have improved significantly in the third quarter due to COVID-19. Also the company’s varicella virus vaccine line-up has been updated to a new generation. Instead of the existing Suduvax, the new Barycela would be sold from this year. A pharmaceutical industry insider noted, “The companies would probably integrate the previously dispersed sales forces for their own products. The sales gap would not be that drastic.”
- Company
- Allergan Korea names Kim Sook-hyun as new CEO
- by Jan 11, 2021 06:10am
- New CEO, Kim Sook-hyun Allergan Korea Aesthetic-AbbVie Company said it has selected Kim Sook-hyun as the new CEO as of Jan. 1 She is a global healthcare professional with 22 years of experience in Korea, Asia, and headquarters receiving an MBA at Kelley School of Business after graduating from industrial pharmacy at Seoul National University. She joined Abbott Korea in 2006, as the Humira Business Unit Manager and served as the director of Commercial Business Divisions in Japan and Asia Pacific in Singapore in 2011. In 2015, she took over the head of the Immunization Division at AbbVie, Korea. Since 2018, she has been contributing to the establishment of immune drug brand strategy and organizational change by serving as the global marketing and commercial division of the AbbVie headquarters, as well as the global marketing director for new business markets in Japan and Australia. She said, "I am pleased to be with Allergan Aesthetics for the growth and development of Korean business, which has led the global innovation in the medical aesthetics field, and I feel a heavy responsibility at the same time. Based on the experience accumulated in the pharmaceutical market, we will do our best to provide cutting-edge medical esthetic solutions to meet the expectations and demands of the rapidly evolving Korean medical beauty market."
- Company
- 51 Jardiance patent-challenging generics released in 4 years
- by Kim, Jin-Gu Jan 08, 2021 06:20am
- Product image of Jardiance Six more pharmaceutical companies are to evade the patents on Boehringer Ingelheim Korea’s antidiabetic sodium-glucose co-transporter-2 (SGLT2) inhibitor Jardiance (empagliflozin). As a result, total 51 companies would be able to avoid charges on infringing the product’s patent. The pharmaceutical industry source reported on Jan. 7 that the Intellectual Property Trial and Appeal Board approved of Kolmar Korea and Kolmar Pharma’s request to negatively confirm the scope of Boehringer Ingelheim Jardiance’ crystalline form patent on Jan. 5. And on Jan. 6, the Board also accepted the request filed by Kuhnil Pharm, Penmix, GL Pharma and Kyongbo Pharmaceutical. Now there are two outstanding cases left without a ruling, yet. The industry anticipates the generic makers—Korea United Pharm and Korea Biochem Pharm—would win the case challenging the Jardiance’ crystalline form patent. If they were to win, total 53 companies would be able to overcome Jardiance patent barrier. Since Chong Kun Dang first evaded the patent in May 2019, other generic companies have followed the footstep and challenged the patent. The generic companies mostly won the cases. The challenged patent is to expire in December 2026. The generic companies that successfully challenged the original’s patent may launch their follow-on drugs after March 2025, when the product patent expires. In four years time, 50 companies could release generics to the market all at once.
- Company
- Korean-made novel drug Kanarb keeps on evolving
- by Kim, Jin-Gu Jan 08, 2021 06:20am
- Product image of Kanarb Boryung Pharmaceutical’s star Kanarb (fimasartan) has added a new indication after a decade. Now the drug is indicated to reduce proteinuria in a hypertensive diabetic patient. In the highly saturated market for angiotensin II receptor blocker (ARB) for hypertension, Kanarb has found a new weapon to break through the stagnated growth. Besides the indication expansion, Boryung Pharmaceutical is also seeking for Kanarb combination drug, adding a variety of doses and expanding user age group to drive the prescription growth even after a ten-year anniversary. ◆A third ARB to be indicated to reduce proteinuria confirming superior effect than losartan On Jan. 6, Boryung Pharmaceutical announced the Ministry of Food and Drug Safety (MFDS) newly approved another indication for Kanarb last year. The new indication is to lessen proteinuria in hypertensive type 2 diabetic chronic kidney disease (CKD) patient as an antihypertensive treatment. Now a patient with diabetic CKD can be prescribed with Kanarb. The Korean Society of Hypertension reported 9.02 million patients in South Korea are being treated for their hypertension as of 2018. Among the total patient size, 26 percent, or 2.35 million patients, has a diabetic complication. CKD is the most common complication for a diabetic patient, as two out of ten are suffering from CKD. Because of the medical situation, the healthcare providers primarily prescribe an angiotensin converting enzyme inhibitors (ACE inhibitors) or ARBs to a diabetic CKD patient with hypertension. Prior to Kanarb’s indication expansion, losartan and irbesartan were the only ARB indicated to treat a diabetic CKD. But the new indication has opened a new door for Boryung Pharmaceutical to tap on the potential market of 500,000 patients. The base of the indication expansion, the FANTASTIC study confirmed Kanarb’s effect of reducing proteinuria is significantly better than that of losartan. The Korean company is apparently working on marketing strategy focusing on the indication. ◆Ten years in the market, Kanarb keeps developing doses and combination treatments After ten years, Kanarb was able to add another indication. The drug was first approved by MFDS in September 2010 as a first antihypertensive new drug developed by a Korean company and was released to the market in March 2011. Boryung Pharmaceutical also expanded Kanarb’s doses ranging from 30 mg to 60 mg and 120 mg. Moreover, the company released combination drugs like Lacor (fimasartan plus hydrochlorothiazide) in 2013, and Dukarb (fimasartan plus amlodipine) and Tuvero (fimasartan plus rosuvastatin) in 2016. And in February and September last year, the company also launched Dukaro (fimasartan plus rosuvastatin plus amlodipine) and Akarb (fimasartan plus atorvastatin), respectively, to further diversify the Kanarb line-up. In this year, the company is planning to launch a three-substance combination treatment including fimasartan, amlodipine and hydrochlorothiazide. The drug is now also available for a wider range of age groups as well. The initially stated caution on the label, ‘no record of administering the drug to a patient aged over 70,’ was removed to provide access of the drug to elderly patients aged 71 and over. The constant expansion of the drug use is the source of prescription volume increase. A pharmaceutical market research firm UBIST reported the Kanarb family has generated 94.3 billion won as of November last year. Combining the December prescription volume, it would have exceeded 100 billion won mark. Kanarb single drug alone has generated 45.1 billion won as of last November, showing a 5-percent growth compared to the previous year same time. Although the drug has been in the market for over a decade, its market presence is still growing. Boryung Pharmaceutical could also shoot for the patent term extension with the new indication. Kanarb’s product patent is to expire in February 2023. If the company adds an indication patent, Kanarb’s patent term would be extended by 15 years to 2038. However, the Korean company official mentioned “The term extension is still under review.”
- Company
- SK Bioscience and GSK signed a joint sale of 5 vaccines
- by Kim, Jin-Gu Jan 08, 2021 06:19am
- Product photos of 5 vaccines that SK Bioscience and GSK signed a joint sales contract. Cervarix, Menveo, Boostrix, Havrix, and Priorix clockwise from top left SK Bioscience has signed a joint sales contract with GSK for five vaccines. SK Bioscience announced on the 6th that it has signed a co-promotion contract for major vaccines with GSK to expand the domestic vaccine market. This is the content that SK Biosciences jointly sells and distributes vaccines developed by GSK in Korea. These products are ▲Tdap (tetanus, diphtheria, pertussis) vaccine Boostrix ▲ meningococcal vaccine Menveo ▲ hepatitis A vaccine Havrix1440 ▲ (measles, parotitis, rubella) vaccine Priorix ▲ cervical cancer vaccine Cervarix. Based on its domestic sales network, SK Bioscience is in charge of sales of Boostrix, Menveo, Havrix1440, and Priorix in the adult market, and sales of Cervarix in the entire market including infants and children. The domestic market size of the five vaccines that SK Bioscience and GSK signed a joint sales contract was about ₩128 billion last year. Boostrix is vaccinated in adolescents and adults over the age of 10 and is the only vaccine in Korea that can be vaccinated to seniors over 65 years of age. Menveo is the only meningococcal vaccine available to the widest range of age groups and can be administered from 2 months of age. Havrix, the world's first hepatitis A vaccine, is sold in more than 100 countries. Cervarix can prevent cervical cancer as well as anal cancer and is sold in more than 130 countries. An-joon Choi, head of the marketing division of SK Bioscience, said, "Through this agreement, we have secured a new growth engine in the vaccine market. In the future, we will expand the market and strengthen our position as a leading company by securing a variety of self-developed vaccines and co-sale vaccines."
- Company
- Cyramza·Tarceva therapy is expected to be proposed
- by Eo, Yun-Ho Jan 08, 2021 06:19am
- It is noteworthy whether the first combination option of targeted anticancer drugs to enter insurance coverage in the first-line lung cancer therapy will be possible. According to related industries, first-line therapy for non-small cell lung cancer (NSCLC) VEGF receptor 2 antagonist Cyramza (Ramucirumab) and epithelial cell growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) Tarceva (Erlotinib), It is expected that the combination therapy of Tarceva (Erlotinib) will be presented to the Review Committee for Cancer Diseases of the HIRA this year, which will be held next week. The combination therapy of the two drugs was approved by the EMA in January and the FDA in June. The new combination targeting VEGF and EGFR is attracting attention because it has shown efficacy in mutant patients such as EGFR exon 19 deletion and exon 21 (L858R), which have been relatively weak so far. Cyramza-Tarceva combination therapy confirmed the possibility of a through phase 3 RELAY trial. In the study, the combined use of Cyramza and Tarceva reduced the risk of mortality by 40% compared to Tarceva alone, and progression free survival (PFS) was also 19.4 months, which was more than 7 months different from the control group. Overall Survival (OS) has not yet been derived. The median follow-up was 20.7 months, and the objective response rate was similar to Cyramza (76.3% in the combination group and 74.7% in the Erlotinib alone group, but the median duration of response was 18 months and 11.1 months.) It is also encouraging that about 70% of them included East Asians. Lee Ki-hyung, professor of hematology and oncology at Chungbuk National University, said, "The EGFR-TKI target therapy, which was used for the treatment of non-small cell lung cancer of existing EGFR mutations, had a relatively low clinical effect in the exon 21 substitution group compared to the exon 19 defect group, so improvement was needed. He added, "The dual inhibition mechanism of Cyramza-Tarceva combination therapy is expected to more effectively inhibit the growth of cancer cells compared to inhibiting one mechanism. It is a remarkable treatment option in terms of overall treatment." Meanwhile, Cyramza was listed as refund type of risk sharing agreement (RSA) in second-line gastric cancer therapy in May 2018. It is domestically approved to ▲second line therapy for advanced/metastatic gastric cancer or ▲metastatic colorectal cancer patients with advanced disease during or after treatment including Bevacizumab, Oxaliplatin, and Fluoropyrimidine, and combination therapy with FOLFIRI (Irinotecan, Folinic acid, 5-FU) ▲patients with metastatic non-small cell lung cancer whose disease progresses during or after chemotherapy including platinum as a combination therapy with Docetaxel. Lilly (a developer of Cyramza ) is also in the process of insurance benefits about Cyramza monotherapy for patients with advanced or unresectable hepatocellular carcinoma that has a serum alpha fetal protein (AFP) of 400 ng/mL or more and patients not tolerated after Nexavar (Sorafenib) administration previously.
- Company
- Mitsubishi Tanabe licensed to market narcolepsy drug Wakix
- by Jan 08, 2021 06:18am
- On Jan. 4, Mitsubishi Tanabe Pharma Korea (CEO : Yomogida Osamu) announced the Ministry of Food and Drug Safety (MFDS) has green lit a narcolepsy treatment Wakix Film Coated Tablet (pitolisant hydrochloride) on Dec. 30, 2020, for marketing in the South Korean market. Wakix is indicated to treat cataplexy in adult patients with narcolepsy. The marketing approval would allow Wakix to be the only treatment option for cataplexy in narcolepsy. A rare chronic disease narcolepsy has limited treatment option in South Korea. In the U.S. and EU, modafinil, sodium oxybate, solriamfetol and pitolisant are used as a narcolepsy treatment, but only modafinil and an isomer armodafinil are approved in South Korea. Narcolepsy is a sleep disorder causing difficulty in regulating sleep-wake cycles due to loss of the neurons creating hypocretin in brain. Major symptoms include excessive daytime sleepiness (EDS) and catalepsy that can enter REM sleep directly from a waking state. Catalepsy is known to be expressed in 70 percent of narcolepsy patients. Wakix is the first treatment approved in South Korea with confirmed clinical efficacy and safety in treating catalepsy. Wakix, a first-in-class medication, is a selective histamine 3 (H₃) receptor antagonist/inverse agonist. Its efficacy could be mediated through its activity at H₃ receptors, thereby increasing the synthesis and release of histamine, a wake promoting neurotransmitter. CEO Yomogida Osamu of Mitsubishi Tanabe Pharma Korea stated, “We are exhilarated to provide an innovative treatment option to South Korean patients with narcolepsy through the health authority’s approval. Wakix is the only narcolepsy treatment in South Korea that has proved safety and efficacy in treating both EDS and catalepsy, the most common symptoms of narcolepsy. The company would do its best to bring practical medical benefit to South Korean patients and healthcare providers.” Wakix was designed and developed by a French-based pharmaceutical company Bioprojet. After the drug was first approved as an orphan drug by the European Medicines Agency (EMA) in March 2016, Wakix has been prescribed to patients with narcolepsy in the U.K., France, Germany and other European countries. In August 2019, the drug also earned the U.S. Food and Drug Administration’s (FDA) approval as well.
- Company
- SK Chemical's Ongentys can be prescribed at BIG 5
- by Eo, Yun-Ho Jan 06, 2021 06:20am
- SK Chemicals' Ongentys can be prescribed in general hospitals. According to related industries, the 3rd generation COMT inhibitor Ongentys (Opicapone) has passed the drug commitee (DC) of Big 5 hospitals such as SNUH, AMC, and Shinchon Severance Hospital. Ongentys, which was listed at a drug price of ₩2,515 last October after domestic approval in November 2019, was introduced by SK from the Portuguese pharmaceutical company BIAL, and was launched with the convenience of taking once a day. Unlike the second-generation COMT inhibitor, there were no side effects associated with severe diarrhea and urine discoloration, and no special safety issues appeared even when long-term administration for more than 1 year. Parkinson's disease, which has the second highest prevalence along with dementia among degenerative neurological diseases, has not yet been developed, so symptomatic management with drug therapy is the only general treatment. Levodopa, a basic drug for Parkinson's disease treatment, has been pointed out as a problem with motor fluctuation, which changes the duration of the drug when administered for a long time. In order to solve this problem, COMT inhibitors are being administered in combination. However, Entacapone, a second-generation COMT inhibitor, had a short duration of drug effect, so it was necessary to take the drug more than 5 to 8 times a day. In addition, side effects such as diarrhea and urine discoloration were also a problem. Meanwhile, it obtained US FDA approval in April of last year after EMA approval in 2016. In Asia, it was released for the second time in Korea after Japan.
- Company
- SK Bioscience loses MSD vaccines but nabs GSK vaccines?
- by Kim, Jin-Gu Jan 06, 2021 06:19am
- SK Bioscience is reportedly sealing the deal on commercializing four types of GSK vaccines in South Korea. When the deal is finalized, SK Bioscience would be able to fill the gap of four types of MSD vaccinea taken over by HK inno.N last year. According to a pharmaceutical industry source on Jan. 5, SK Bioscience and GSK Korea are in discussion for co-promotion contracts on a cervical cancer vaccine Cervarix, a hepatitis A virus vaccine Havrix, a meningococcal vaccine Menveo, and a Tdap vaccine Boostrix. SK Bioscience and GSK Korea left no official comments, but the industry seems to be aware that the two companies are close to inking the co-promotion deal. Since late last year, the local sales licenses for the global pharmaceutical companies’ vaccines have been shuffled around. In last November, seven MSD vaccines’ sales licenses, previously owned by GC Pharma and SK Bioscience, have been handed over to HK inno.N. Apparently, the Korean company started taking actions from the break of the new year. The seven MSD vaccines included cervical cancer vaccine Gardasil 4 and 9, a shingles vaccine Zostavax, a rotavirus vaccine RataTeq, a hepatitis A virus vaccine Vaqta, a measles, mumps, and rubella vaccine MMR2, and a pneumococcal vaccine Prodiax. The popular vaccines like Zostavax and Gardasil were handled by GC Pharma, and the rest of the vaccines—RotaTeq, Vaqta, MMR2 and Prodiax—were sold by SK Bioscience. Zostavax and Gardasil raised 120 billion won a year, whereas RotaTeq, Vaqta, MMR2 and Prodiax generated approximately 24 billion won a year. In just two months, SK Bioscience is getting its hands on GSK vaccines. Currently, four GSK vaccines are sold by Yuhan Corporation and Kwangdong Pharmaceutical, each focused on sales in children and adolescents, and in the rest of the target, respectively. The industry experts expect SK Bioscience would nab the vaccines sold by Yuhan. GSK has reportedly suspended the supply of vaccine to Yuhan as of Dec. 31, 2020. If SK Bioscience successfully signs the co-promotion deal on the four vaccines by GSK, the company would be able to compensate the loss from losing MSD’s Cervarix, Havrix, Menveo, and Boostrix, which used to generated 28 billion won annually. A pharmaceutical industry insider commented, “GSK has cut the ties with Yuhan for the new contract. Highly likely that SK Bioscience would take over all the vaccine sales and marketing, except for the pediatric market. However, both SK Bioscience and GSK are reserving any definite answer. SK Bioscience official explained, “We have no comment to make on the domestic sales licenses on GSK vaccines.” GSK official also stated, “There is nothing to confirm except that the talk is in progress.”
