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- 2026-03-18 22:46:44
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- Big 5 green lit another CDK4/6 inhibitor Verzenio
- by Eo, Yun-Ho Jul 30, 2020 06:18am
- General hospitals in South Korea are entering prescription code for anticancer treatment Verzenio. According to pharmaceutical industry sources on July 28, drug committees at the Big Fives including Seoul National University Hospital, Severance Hospital and Samsung Medical Center, and other major general hospitals like National Cancer Center, Ajou University Hospital, and Chonnam National University Hwasun Hospital have passed Lilly’s Verzenio (abemaciclib) for prescription. From last month, the treatment was listed for healthcare reimbursement as a combination therapy with an aromatase inhibitor for treating perimenopausal women with HR+/HER2- advanced or metastatic breast cancer for first-line endocrine therapy, or as a combination therapy with fulvestrant for treating women with HR+/HER2- advanced or metastatic breast cancer. All doses of 50 mg, 100 mg, and 150 mg of the medication are priced at 49,587 per tablet. The medication has settled a risk sharing agreement (RSA) to receive reimbursement to treat patients with HER2- advanced breast cancer in combination with AstraZeneca’s Faslodex (fulvestrant). As the major general hospitals green lit Verzenio, the cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor prescription war would get escalated. A CDK4/6 inhibitor Verzenio can be prescribed to perimenopausal women with HR+/HER2- advanced or metastatic breast cancer either for first-line endocrine therapy combined with an aromatase inhibitor, or for combination therapy with Faslodex after receiving endocrine therapy. The first-in-class CDK4/6 inhibitor Ibrance by Pfizer requires seven days of off treatment after 21 consecutive days of once-daily 125 mg administration, whereas Verzenio can be administered every day. Ibrance has also expanded the coverage as a fulvestrant combination therapy along with Verzenio. Ibrance’ efficacy of significantly improving progression-free survival (PFS) as a second-line therapy has been confirmed during PALOMA-3 study. Besides patients with early stage breast cancer, the CDK4/6 inhibitor also showed consistent effect in patients with stage 4 metastatic breast cancer that affected their lungs and bones. Verzenio has recently attracted the industry’s interest, when it completed MONARCH2 study that showed improved PFS as well as overall survival (OS). The achievement was unprecedented for a CDK4/6 inhibitor. As a part of secondary endpoints, the OS of both pre and postmenopausal women was observed.
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- 2,000 reimbursed items were registered for 3 months
- by Chon, Seung-Hyun Jul 29, 2020 06:34am
- Pharmaceuticals have launched generic products enormously ahead of the new drug price system. In the last three months, about 2000 generics have been licensed and listed. It is to receive upper limit price before applying cascading drug price system that the later it is registered, the lower the price. The government's restrictions on generics have led to the release of many generics. According to the MOHW's announcement on the 28th, “The Amendment of the Pharmaceutical reimbursed list and the upper limit price table”, from August 1st, a total of 836 products will be newly added to the health insurance reimbursement list. Most of the new drugs listed are generics. Products listed in August are Pregabalin (14), Gabapentin (13), Aceclofenac (6), and Celecoxib (7). More than 100 eye drops have been newly registered, and it is identified as newly registered products by dose among previously approved products. For eye drops, the upper limit price should be separately listed in the reimbursed list by dose. In particular, small and medium-sized pharmaceutical companies were actively launching generic products. Kims Pharma registered 48 generics in August. Union Korea Pharm (40), SCD Pharm (36), Reyon (36), Mothers Pharm (31), Kukje pharm (27), Korea United Pharm (22), DHP Korea (20) ), Lite pharm (20), Pharvis Korea (20) have newly registered eye drops, and many small-sized companies have registered generics. Number of new monthly registered drugs (unit: # of Drug, data: The MOHW) The number of new drugs listed in August is the highest this year. From January to May of this year, about 300 medicines were newly added to the reimbursed list every month. Following the list of 558 in June and 653 in July, the number of products on the list is increasing rapidly. In the last three months, more than 2000 generics have been newly registered. The intention is to receive upper limit price before the new price system is implemented. The new generic drug price system, which has been in effect since last month, includes cascading drug price system that lowers the upper limit as the registration period is delayed. If more than 20 generics are listed in a particular generic market, the upper limit for new listed items will be up to 85% of the existing lowest price. According to the MOHW, the previous drug price system is applied to the products that were registered in May. Most products listed in August are products that have been registered in May. This means that generic drugs that have been registered for benefits since June will receive a lower price than existing products due to the cascading drug price system. Since there are more than 20 generics in the majority of patent expiration drug markets, generics listed from September are forced to receive lower drug prices than before. Since the cascading drug price system does not apply only to generic products listed in August, the application in May is the last chance to receive the previous high price. In fact, until May, generic approval has been increased significantly. There were an overwhelming number of products that were approved by other companies as a consignment method without direct production. According to the MFDS, a total of 1399 generics were approved in the first half of this year through a full-process consignment method. This is the number of generics licensed through another company's bioequivalence study data. In January and February, 161 and 206 consigned generics were approved, respectively, and exceeded 300 in April and May. In 2013, the number of consigned generic licenses began to increase, but since the government's generic license and drug price regulation policies began to be established last year, the consigned generics are approved. In 2012, 50 licensed generics were licensed, but in 2013, the number was 500, a 10-fold increase in a year. In 2015 and 2016, there were more than 1,000 generics licensed for consignment. In 2017 and 2018, 681 and 751 commissioned generics were approved, respectively. Last year, 3,173 consignment generics were approved. It was more than twice as many as 1,306 cases in 2016. From last year to the first half of this year, there were 4,572 consigned generics. According to the HIRA, the total number of registered drugs in August this year is 26,328. It is the largest for 8 consecutive months. It increased by 3,066 from 27,754 in December last year, and more than 3,000, up from 20,689 in November 2018, a year and nine months ago. Despite the government's movement to regulate generics, many generics were released. However, starting in September, the number of new generics are expected to drop significantly. It is analyzed that pharmaceutical companies are equipped with as many generics as possible prior to the implementation of the cascading drug system. In fact, there were 12 licensed generics in June with the cascading drug price system, less than a tenth of the previous month.
- Company
- HCV drug Mavyret prescription goes down by 31% amid COVID-19
- by Kim, Jin-Gu Jul 29, 2020 06:33am
- Although Mavyret (glecaprevir) dominated the hepatitis C treatment market as soon as it was launched, the treatment took a steep fall in prescription volume. The pharmaceutical industry sources argue the 31-percent drop compared to last year would have been impacted by decreased number of patients and COVID-19. According to the pharmaceutical market research firm UBIST on July 27, Mavyret’s outpatient prescription sales from last January through June marked 16.4 billion won. Still the treatment is accounted for 74 percent of the Korean hepatitis C treatment market, but the situation is not exactly rosy. Compared to last year, the prescription sales have gone by down 31 percent. In the first half of 2019, Mavyret generated 23.7 billion won. In 12 months time, the figure plummeted by 7.3 billion won. The fall has continued for five consecutive months. After peaking at 13.1 billion won in the second quarter of 2019, the prescription has been sliding down from 12 billion won in third quarter last year, 8.8 billion won in fourth quarter last year, 8.8 billion won in last first quarter, and 7.7 billion won in last second quarter. Hepatitis C treatment prescription volume in 2020 H1 and Mavyret’s quarterly prescription volume (Source: UBIST) The research firm claims two complicated causes have affected the state. First, the hepatitis C patient size has shrunk. Direct-acting antiviral (DAA) medications treating hepatitis C, such as Mavyret, demonstrates high cure rates and has short therapy duration. Naturally, the overall patient size is constantly narrowing as increasing number of patients are cured. Korea’s Health Insurance Review and Assessment Service (HIRA) reported the number of hepatitis C patients last year was at 44,483, which went down by 10 percent in three years from 49,569 in 2016. The hepatitis C treatment market has been following the descending curve since the third quarter in 2016. The market volume valued at 68.5 billion won has dwindled to 10.3 billion won in the last second quarter. The current market is now at about one-seventh of its peak. The last quarter actually hit the historic low since the DAA medication entered the market. In last month, Bristol Myers Squibb (BMS) that first opened the hepatitis C treatment market withdrew ‘Daklinza plus Sunvepra’ combination therapy from the Korean market. The company explained it was because the competition has gotten increasingly intense, while the demand lessened. Yearly count of hepatitis C patients (Source: HIRA) and quarterly trend in hepatitis C treatment market volume (Source: UBIST) Moreover, this year has been rough for the market amid COVID-19. As patients have been refraining from visiting hospitals and clinics due to COVID-19, they were less exposed to the main cause of hepatitis C like infection through blood transfusion and syringe. Regardless of blood borne infection, the hepatitis C infection transmission was apparently impacted by social distancing.
- Company
- Eight generic companies for Lixiana are expected to compete
- by Kim, Jin-Gu Jul 29, 2020 06:31am
- LixianaHanmi and Boryung overcome the patent of oral anticoagulant (NOAC) 'Lixiana' (Edoxaban). Eight generic companies, including those, are expected to compete after the patent expires in November 2026. The Intellectual Property Trial and Appeal Board recently decided on 'claims established'' at a trial to confirm the passive scope of rights to Lixiana composition patent claimed by Hanmi Pharmaceutical and Boryeong Pharmaceutical. As a result, eight companies have overcome Lixiana composition patent. Previously, in April, Samjin, HK inno.N, Chong Kun Dang, Kolmar pharma Hutecs Kolmar Korea received the same trial. However, they failed to overcome Lixiana's material patent. Accordingly, eight companies can enter the generic competition after November 10, 2026, when the material patent expires. They met two of the three requirements for generic for exclusivity right. If the requirements are met until the first application for permission, it is expected that there will be no difficulty in winning generic exclusivity. Lixiana is the representative product of the NOAC market. It was the latest release compared to other items, but It is superior to the results of JXarelto (Rivaroxaban), Eliquis(Apixaban), and Pradaxa (Dabigatran). According to UBIST, Lixiana's outpatient prescription amounted to ₩59.9 billion last year. This year, only ₩31.7 billion was prescribed in the first half.
- Company
- [Photo]“Dismissal is a murder” Sanofi Labor Union protests
- by An, Kyung-Jin Jul 29, 2020 06:30am
- On July 27, the Sanofi-Aventis Korea Labor Union Chapter of Federation of Korean Chemical Workers' Unions (FKCU) was gathered in front of the company’s Seoul headquarters to denounce the management’s unfair disciplinary action Sanofi-Aventis Korea’s Disciplinary Committee meeting was scheduled in the afternoon to deliberate a salesperson, who made false reports of calls and received a ‘letter of recommended dismissal.’ Two other salespeople who were accused the same have reportedly ‘resigned by recommendation.’ The labor union claims the two employees have been intervened by the management unjustly. And the union plans to continue their protest against the company to defend the job security of the other one employee that refused the management’s offer and received a letter of dismissal. The chief of Sanofi-Aventis Korea Labor Union, Park Young stated, “An unfair treatment by the Disciplinary Committee is as cruel as committing a murder. Hopefully, the committee would make a fair decision,” while “we would fight against the management until it stops repeating the same action of imposing excessive penalty and dismissing employees.”
- Company
- Generics for Betmiga competition gets fierce
- by Kim, Jin-Gu Jul 28, 2020 06:37am
- BetmigaFull-fledged competition began in the generic market of “Betmiga (Mirabegron),” which has annual outpatient prescriptions of ₩65 billion. Hanmi and Chong Kun Dang, which received generic for exclusivity, recently released generics. The two companies plan to focus on expanding the market until February next year when the trial period expires. According to the pharmaceutical industry on the 24th, Chong Kun Dang has released "Selebeta", which is a generic for Betmiga, from the 1st of this month. Hanmi has been launching and selling “Mirabek” since June, a month earlier. The overall prescription amount is a little higher than that of Hanmi, which was released a step ahead, but the two companies are said to be very similar. As the original market was so large, the officials said that the prescription performance was good. Since the launch of Betmiga, more than 40 domestic companies have filed for patent evasion. Since 2015, invalidity trials and passive judgments on the scope of rights have been requested for material patents, formulation patents, crystalline patents, and use patents. As a result, 11 companies succeeded in overcoming formulation patents, crystalline patents, and use patents excluding material patents. These are Hanmi, Chong Kun Dang, JW Pharma, Daewoong, Ildong, Intropharm, Alvogen Korea, Kyung Dong, Sinil, Hanwha, and Shinpoong. Only Chong Kun Dang and Hanmi have won the right of generic for exclusivity. They received the right of copyright in April. As the material patent expired on May 3, the two companies launched a series of products. Other pharmaceutical companies that have evaded patents are said to have been disrupted in bioequivalence tests. It is expected that the generic competition will get hotter after February next year. Other generic companies such as Kyung Dong, Sinil, and Shinpoong, which are currently undergoing bioequivalence testing, are predicting to join after February 3, next year, when the trial period ends. According to UBIST, Betmiga's outpatient prescription amounted to ₩65.7 billion last year. Betmiga became a blockbuster drug shortly after its release in October 2015. In 2016, it posted sales of ₩28.8 billion, ₩41.7 billion in 2017, and ₩54.8 billion in 2018.
- Company
- MFDS collects acetaminophen to confirm impurity
- by Chon, Seung-Hyun Jul 28, 2020 06:33am
- 식품의약품안전처 전경 The South Korean government is initiating an investigation on impurity contamination in an active pharmaceutical ingredient (API), acetaminophen. As the risk of impurity contamination in API manufactured by a Chinese manufacturer was raised recently, the government started proactively collecting and testing the API used in Korea. If the widely used acetaminophen were to be found with unacceptable level of impurity, the pharmaceutical industry would be unable to avoid a heavy blow. According to pharmaceutical industry sources on July 27, Ministry of Food and Drug Safety (MFDS) has recently visited pharmaceutical companies and taken samples of acetaminophen to confirm the impurity contamination in the API. The government’s action seems to be a follow-up of the concern raised of impurity risk in acetaminophen manufactured and supplied by a Chinese-based bulk pharmaceuticals manufacturer Anqiu Luan Pharmaceutical. A Dutch daily newspaper NRC has reported a few weeks ago that three batches of acetaminophen Anqiu Luan Pharmaceutical manufactured last year have been found with carcinogenic substance, 4-chloroaniline. The substance is apparently genetoxic. Regarding the accusation, Anqiu Luan Pharmaceutical disseminated an official statement to their clients on 15 explaining “4-chloroaniline was not found in the samples from the batch the Dutch client received in the first quarter of last year.” The Chinese manufacturer official said the voluntary investigation result was sent to European Directorate for the Quality of Medicines (EDQM) and elaborated “The acetaminophen manufacturing procedure does not create a chemical condition to generate 4-chloroaniline, and the level of impurity risk can be managed during the procedure.” According to the manufacturer’s explanation, the carcinogen can hardly generate during the acetaminophen API production line. But MFDS presumably has decided to take a deeper look into the API used in Korea to proactively check the impurity risk. Sources confirmed a significant volume of acetaminophen manufactured by the Chinese company has been exported to Korea. MFDS’ Drug Master File (DMF) registration shows that total 100 items of acetaminophen are available in the Korean market. And 20 of the items use API supplied by Anqiu Luan Pharmaceutical. DMF registration of products using acetaminophen manufactured by Anqiu Luan Pharmaceutical (Source: MFDS) If the ministry’s investigation find impurity in Anqiu Luan Pharmaceutical’s API, the impact on the Korean industry would be inevitable. MFDS has reportedly collected acetaminophen manufactured by other Korean and global companies as well. Analgesic substance acetaminophen is widely used in OTC drugs, such as Tylenol, Penzal and Geworin. And for prescription drugs, the API is used in brands like Ultracet. Curretnly, total 120 Korean companies are in the Ultracet market. In worst case scenario, the general Korean pharmaceutical industry would be shaken to the core by the Korean ministry discovering unacceptable level of impurity in acetaminophen. Since the impurity risk incident with valsartan in July 2018, the substance contamination issue has been spreading through ranitidine, nizatidine and metformin. All the incidents started from a foreign country sources addressing an impurity risk in specific pharmaceutical substance, which led to MFDS investigating the collected API and finished products and banning the sales of certain product in the Korean market. This is why the pharmaceutical companies are closely watching the MFDS’ investigation and following actions. MFDS official said, “The ministry is collecting and investigating acetaminophen to proactively confirm the risk of impurity.”
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- MFDS to tighten up regulations on appetite suppressant
- by jung, sae-im Jul 27, 2020 06:31am
- The South Korean health authority drafted regulations preventing the abuse of psychoactive appetite suppressants. The draft contains high-level of regulations like adopting active substance designation system used in narcotics control, which can heavily impact the relevant industry. According to pharmaceutical industry sources on July 24, Korea’s Ministry of Food and Drug Safety (MFDS) is planning to manage psychoactive appetite suppressants. Some of the approaches unveiled were introducing quarterly active substance designation system like the narcotics control, notifying amfepramone and mazindol as restricted substance, and designating psychoactive appetite suppressants as subjects to submit a risk management plan (RMP). Psychoactive appetite suppressant management plan drafted by MFDS First, the quarterly substance designation system is used by the government to control narcotic drugs in Korea in accordance to the Single Convention on Narcotic Drugs of 1961. The government intends to enforce the system to handle the appetite suppressant on the equivalent level to narcotic drugs. The current system designates each company on which narcotic substance to supply after reviewing the projected yearly use volume of narcotic substance and quarterly plan of active psychoactive drug use submitted by each supplier company from the previous year. When the result is notified to each company, the narcotic drug manufacturers are allowed to purchase the active substance strictly following the designation conditions. MFDS sketched out a plan to survey each company’s inventory this year, and enforce the new regulation from 2021 after finalizing and notifying the appetite suppressant manufacturing approval plan in November. When the new regulation comes in effect, the drug manufacturers can only manufacture the suppressant drugs as much as the government allows. Basically, the government would be invested with the power to set down the manufacturing volume of psychoactive appetite suppressant. Moreover, the government aims to newly restrict approval on amfepramone and mazindol. The official notification would be issued around August. In the past, the approval on phentermine and phendimetrazine has been restricted due to frequent reports of abuse. The ministry now plans to expand the restricted scope of substances and include amfepramone and mazindol. The designated substance drugs may be restricted when seeking for narcotic drug handling approval, manufacturing or importation approval. Lastly, the ministry plans to designate psychoactive appetite suppressants as drugs required to submit a RMP. The system usually targets new drug or orphan drug, but a drug the Minister of Food and Drug Safety acknowledges the need for RMP submission due to severe adverse reaction reported may also be designated. MFDS is shooting for early next year to enforce the designation. Pharmaceutical companies with drugs required to submit RMP have to comply with the plan and regularly submit evaluation result. Until the final designation is announced, the ministry is to recommend the companies to voluntarily practice risk minimization actions as a pilot program. Also the government body would soon survey demands on the pilot program from the participating companies. On July 21, MFDS convened a conference with the affected industry and shared the said details. The ministry would make final decisions after reviewing the industry’s opinion. Regardless of the abuse prevention and safe use policies enforced on appetite suppressants so far, MFDS has decided to take the stricter action as the drugs were still excessively prescribed. In 12 months time from July 2018 through June 2019, 24,000 healthcare institutes prescribed the appetite suppressants to 1.29 million patients, which adds up to 6.11 million cases of dispensing and use of the drugs. According to 2018-2019 technical reports published by International Narcotics Control Board (INCB), Korea’s phentermine and phendimetrazine substance importation volume is one of the highest in the world. Analyzing appetite suppressant prescription and administration data, the report confirmed frequent cases of abnormal use suspected of abuse. And apparently, these drugs have been globally criticized for the wide discrepancies between the submitted projection psychoactive drug substance use volume and the actual manufactured volume. However, the relevant industry points out the blueprint of the regulation do not match with the goal of preventing drug abuse. An industry insider who requested anonymity noted, “The government should rather actively promote drug administration instruction or safe use, if the drug abuse is the issue. Many of the industry associates say regulating and controlling the actual manufacturing and production of the drugs is inadequate.” Meanwhile, the obesity treatment market in Korea, including the psychoactive appetite suppressant market, is valued at approximately 150 billion won.
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- First-line Cyramza+Tarceva combo to treat NSLCL in Korea
- by Eo, Yun-Ho Jul 24, 2020 06:25am
- A targeted therapy combination option could be introduced to the non-small cell lung cancer (NSCLC) treatment area. The pharmaceutical industry sources reported, Lilly Korea has recently submitted an application to expand the drug’s indication to treat patients with NSCLC as a first-line combination treatment of vascular endothelial growth factor receptor (VEGFR)-2 antagonist Cyramza (ramucirumab) and epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) Tarceva (erlotinib).. The combination therapy has been approved by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) in last January and June, respectively. The new combination targeting VEGF and EGFR has demonstrated efficacy in patients with EGFR exon 19 deletion and exon 21 (L858R) mutation. The promising efficacy of the Cyramza-Tarceva combination therapy was confined in Phase III RELAY trial. In the study, ramucirumab-erlotinib combination has lowered the risk of disease progression or death by over 40 percent against erlotinib alone. And the patient group treated with the combination demonstrated progression-free survival (PFS) of 19.4 months, improving the figure more than erlotinib group by over seven months. The overall survival has not been evaluated, yet. The median time of follow-up was 20.7 months, and objective response rates (ORR) in Cyramza combination group (76.3 percent) and erlotinib group (74.7 percent) were similar. But the median duration of response in the two groups were contrasting with 18.0 months and 11.1 months. Currently in Korea, Cyramza is indicated to treat patients advanced or metastatic stomach cancer as second-line treatment; patients with advanced metastatic colorectal cancer, who have progressed on or after bevacizumab, oxaliplatin, or fluoropyrimidine treatment as combination therapy with FOLFIRI (irinotecan, folinic acid, 5-FU); and patients with metastatic NSCLC after disease progression on or after platinum-based chemotherapy as combination therapy with docetaxel. Besides Tarceva, Lilly also has other clinical trials in progress to confirm treatment efficacy of Cyramza combination therapies with other EGFR TKI like Iressa (gefitinib) or Tagrisso (osimertinib) in treating NSCLC.
- Company
- Genexine, promotes clinical trial of Hyleukin-7·Opdivo
- by An, Kyung-Jin Jul 24, 2020 06:24am
- Genexine announced on the 22nd that the anti-cancer drug 'Hyleukin-7' (GX-I7), which is under development with NeoImmuneTech, has entered a co-clinical trial with BMS. According to Genexine, phase II clinical trial that recently administered 'GX-I7' and BMS' immune checkpoint inhibitor 'Opdivo' (Nivolumab) in patients with metastatic gastric cancer, gastro-esophageal junctional cancer, and esophageal adenocarcinoma was approved by the Food and Drug Administration. Hyleukin-7 is an essential cytokine for the proliferation and maintenance of T cells, which play an important role in immunity in the body. The two companies expect that the combination of Hyleukin-7, which enhances T cells, and 'Opdibo,' a strategy to reactivate T cells that have lost activity, will be synergistic. In addition to Opdivo, 'Hyleukin-7' is being evaluated for its potential to be used in combination with various blockbuster immunocancer drugs. Hyleukin-7 by Genexine has previously entered a number of clinical trials such as ▲Phase Ib/IIa using Roche’s Tecentriq for high-risk skin cancer patients ▲Phase Ib/II in combination with Keytruda by Merck for patients with triple negative breast cancer ▲Phase Ib/IIa in combination with 'Keytruda' for pancreatic cancer, lung cancer, colorectal cancer, triple negative breast cancer, and small cell lung cancer, which have failed immunotherapy inhibitor treatment. In addition, Phase II clinical trials for patients with brain tumors (GBM) are in progress with I-MAB, a NASDAQ listed company. Sung Young-Chul, CEO of Genexine, said, "GX-I7 showed the possibility of treatment when combined with Keytruda in end-stage breast cancer patients based on the mechanism of restoring T-cell hypotension. We expect that Opdivo and GX-I7 combination therapy may be a new treatment option in patients with metastatic gastric and esophageal cancer."
