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- 2025-12-25 06:41:19
- Company
- Propecia is sold in a new package
- by Apr 13, 2022 06:02am
- Organon Korea announced on the 11th that it will introduce a new package of the oral male hair loss treatment Propecia (Finasteride). As for the new package, it applied CI of Organon Korea company. Propecia, which has been sold by MSD Korea for more than 20 years since its launch in Korea in 2000, was officially launched and relocated by Organon Korea, which was spun off from MSD in June last year. Organon will consolidate its position as a major product, Propecia, with its new package. Currently, Propecia is on sale in two packaging specifications: 28 tablets and 84 tablets. Organon Korea will supply changed packages for Propecia 84 tablets first in April, and will supply 28 tablets sequentially from May. Depending on the pharmacy, It sells new packages as the old packages are sold depending on the pharmacy. Han Soo-young, head of marketing at Organon Korea's Propecia, said, "This package change means that Propecia is once again announcing its official departure as a major item of Organon, and only the company name has been changed, but the quality of Propecia's production and packaging is the same as before, and Organon Korea Propecia is the No. 1 oral hair loss treatment in Korea, and we will continue to strive for its original value."
- Company
- KRPIA BOD meets Oh Chang-hyun, the new head
- by Eo, Yun-Ho Apr 12, 2022 06:05am
- KRPIA BOD will hold its first face-to-face meeting with Oh Chang-hyun, director of the MOHW's insurance pharmaceutical dept. According to related industries, KRPIA Board of Director (BOD) will hold a meeting with Oh Chang-hyun, the new manager, and members of the MOHW's Insurance and Pharmaceutical Affairs on the 15th. The meeting is expected to be accompanied by Oh Dong-wook, CEO of Pfizer Korea, Lee Young-shin, a full-time vice chairman of KRPIA, and some members of the board of directors. Through the discussion meeting, KRPIA BOD is a plan to deliver grievances, policies, and pledges from the perspective of pharmaceutical companies within the agenda of "expanding new drug coverage." As the industry has recently emphasized the need for the introduction of the "post-evaluation of lights" system, it remains to be seen how to proceed with discussions with the changed head of the insurance drug department. KRPIA is also discussing with the 20th Presidential Transition Committee to expand the guarantee of new drugs.
- Company
- No. of employees decline sharply due to restructuring/reorgs
- by Apr 12, 2022 06:04am
- The number of employees at multinational pharmaceutical companies has declined sharply due to their active restructuring and reorganizations. Over 200 employees have been laid off in just 4 companies - Roche Korea, Lilly Korea, Sanofi-Aventis Korea, and Zuellig Pharma Korea. According to the Financial Supervisory Service, the number of employees at Roche Korea, Lilly Korea, Sanofi-Aventis Korea, and Zuellig Pharma Korea was 1,109, which was a 16% decrease from the 1,326 of the previous year. Approximately 80 employees left Sanofi-Aventis Korea last year. The number of employees in the company had been 492 at the end of 2020 but was reduced to 413. In the same period, the number of Zuellig Pharma Korea employees decreased by 58, from 293 to 235. Roche Korea’s employees decreased by 52 from 309 to 257. Lilly Korea’s employees decreased by 28 from 232 to 204. The companies above have all actively carried out restructuring and reorganizations last year, influenced by the business model reorganizations conducted to remove or reduce non-core departments by the companies’ global headquarters. Also, the sales department became the main target of restructuring due to the increasing preference for online-based, non-face-to-face sales activities due to COVID-19. The number of employees at Sanofi-Aventis Korea decreased greatly following the split-off and merger of its consumer healthcare business with Opella Healthcare Korea. Before the spilt-off, the company had also offered an early retirement program for its CHC and GenMed divisions. The GenMed division is in charge of non-core prescription drugs of the company other than vaccines (Pasteur), and specialty care (Genzyme). Zuellig Pharma Korea had reduced the number of employees while withdrawing its local pharmacy retail business. The company had notified employees of its plans to dissolve the pharmacy retail business and large-scale restructuring in March last year. The company had decided to undergo such measures due to continuous operating deficits brought on by the lower distribution fees and intensified market competition. The company aimed to lay off about 80 people by eliminating direct sales and leaving only a small number of personnel in online sales services, Lilly Korea had downsized its offline sales services while increasing its online sales. For this, the company had carried out a large-scale ERP since November 2020. At the time, the company explained that its purpose was “The purpose of the reorganization is to increase the productivity and efficiency of the sales division and reinforce various multi-channels including digital programs.” The company had expected 25% of the 100-something employees in its sales division to opt for the ERP, and it is analyzed that a corresponding number of employees have voluntarily retired. Roche Korea had also conducted two ERPs at the end of 2020 and in the previous year. The main subject of the ERP was the sales department. Although around 20% of the 60-70 workforce in sales were expected to opt for ERP, the number that left had exceeded expectations. The number of employees at Roche Korea, which had exceeded 300, was reduced to 250 after ERP.
- Company
- Lutathera’s partner ‘LysaKare’ may be prescribed at GHs
- by Eo, Yun-Ho Apr 11, 2022 05:58am
- ‘LysaKare’, the drug concomitantly used with the neuroendocrine tumor treatment ‘Latathera’ may soon be prescribed at general hospitals. According to industry sources, Novartis Korea’s ‘LysaKare (L-arginine hcl/L-lysine hcl) has passed the drug committee (DC) reviews at 3 of the Big 5 general hospitals – Samsung Medical Center, Seoul National University Hospital, Seoul Asan Medical Center - in Korea. LysaKare was approved as a drug to be used concomitantly with Novartis’s orphan drug Lutathera (lutetium), a neuroendocrine tumor treatment that was approved in July 2020. Lutathera is a radioactive targeted therapy that increases the dose of radiation in the tumor areas. It is an ultra-high-priced but highly effective drug used to treat a very small number of patients. The drug was listed for insurance benefit in March last year and cost ₩104 million for 4 injections before then. LysaKare is used to reduce damage caused by renal radiation exposure during the use of Lutathera. The Ministry of Food and Drug Safety had also designated LysaKare as an orphan drug recently. Specifically, LysaKare is indicated for ‘reduction of renal radiation exposure during peptide-receptor radionuclide therapy (PRRT) with lutetium (177Lu) oxodotreotide in adults.’ Meanwhile, Lutathera’s efficacy had been demonstrated through the Phase III NETTER-1 trial and Phase I/II ERASMUS studies. The primary efficacy endpoint of the NETTER-1 study was progression-free survival (PFS). At the time of primary analysis, the median PFS was not reached for Lutathera and was 8.4 months for the control group, showing that Lutathera reduced disease progression and death by 82% compared to the control group. In particular, the drug had significantly prolonged PFS in patients regardless of tumor size, including those with liver tumors, and demonstrated the possibility of effectively treating various types of patients.
- Company
- HK inno.N's K-CAB has ended Phase 1 in US
- by Kim, Jin-Gu Apr 11, 2022 05:58am
- HK inno.N announced on the 7th that its flagship drug, "K-CAB (Tegoprazan), has successfully ended phase 1 clinical trials in the U.S., a treatment for gastroesophageal reflux disease. The clinical trial was conducted on 30 healthy adults with random assignment, double blinding, placebo control, and repeated administration. K-CAB 25 mg, 50 mg, and 100 mg were administered to clinical participants orally for 7 days, respectively, and pharmacokinetic characteristics and safety were evaluated. As a result of pharmacokinetic evaluation, the blood concentration of K-CAB was proportional according to the content, and similar profiles were maintained on both the 1st and 7th days of administration. In the pharmacological evaluation to measure the acidity (pH) in the stomach, both the 1st and 7th days of administration showed higher acidity than the placebo for 24 hours. In particular, it showed rapid medicinal effects regardless of the dose on the first day of administration. In terms of safety, all doses of K-CAB did not differ from placebo. HK inno.N has been conducting a phase 1 clinical trial of K-CAB with the aim of entering the U.S., the world's largest pharmaceutical market. HK inno.N signed a technology export contract worth about 640 billion won to Braintree Laboratories, a subsidiary of Sebela, a U.S. digestive medicine company, last year when it was undergoing local clinical trials. HK inno.N explained that Braintree Laboratories will be in charge of follow-up clinical trials in the United States and Canada. Braintree Laboratories plans to carry out follow-up clinical trials in the U.S. and Canadian markets as soon as possible. Starting with the smooth completion of the phase 1 clinical trial in the U.S., It will work closely with our local partners to ensure that the Korean new drug K-CAB can be successfully launched in the U.S. market, said Kwak Dal-won, CEO of HK inno.N. K-CAB recorded 109.6 billion won in outpatient prescriptions in Korea last year. Cumulative prescriptions amount to 236.4 billion won over the three years after release. Based on its domestic success, HK inno.N is actively seeking overseas expansion. It has made inroads into 27 countries around the world, including the U.S. In the Chinese market, Luoxin, a local partner, is planning to license and release items in the first half of this year.
- Company
- Rising COVID-19 cases impede progress of bioequivalence test
- by Chon, Seung-Hyun Apr 08, 2022 06:08am
- Pharmaceutical companies are having trouble conducting bioequivalence tests for the development of generics due to COVID-19. The spread of COVID-19 has made it difficult for companies to recruit subjects, and even those recruited are dropping out after being confirmed with COVID-19, causing disruptions in the companies’ schedules. With delays inevitable due to the unexpected pandemic, pharmaceutical companies have been asking authorities to extend the drug pricing reevaluation deadlines that were set for February next year. According to industry sources on the 8th, several pharmaceutical companies have expressed their difficulties in progressing their ongoing bioequivalence tests due to the surge of COVID-19 cases. With hundreds of thousands of people being confirmed with COVID-19 every day, recruiting patients for the bioequivalence test itself is difficult. According to KDCA, 1,683,111 people were confirmed with COVID-19 over the past 1 week since the 6th. With over a million people in self-isolation due to COVID-19, the companies are complaining of difficulties in recruiting necessary subjects. With subject requirements are already stricter than before, difficulties in recruiting subjects for bioequivalent tests have been ongoing for some time. In accordance with the revised Pharmaceutical Affairs Act passed by the National Assembly in November 2018, people who have no experience participating in a clinical trial within 6 months prior to the trial date should be selected as subjects for clinical trials. With the restriction period extended from 3 months to 6 months. the number of participants viable for the tests has also decreased significantly. Also, even the registered subjects are frequently leaving trials to COVID-19. This renders it difficult to conduct a normal bioequivalence test due to the lack of subjects. The drug equivalence standards require 12 or more people in each group -the test group and control group for bioequivalence tests. This means the bioequivalence tests cannot be conducted unless over 24 people register for the tests. If subjects in the test group or control group are reduced to less than 12 due to COVID-19, the bioequivalence test itself may turn to waste. The companies can increase the test group or control group can by recruiting additional subjects, but this would inevitably push back the schedule. An official from a pharmaceutical company said, “We are planning to recruit more subjects than originally planned due to the rapid increase in the number of confirmed COVID-19 cases, but it isn’t easy. Even those who already registered are leaving trials after being confirmed with COVID-19, so we’re having much difficulty conducting the required bioequivalence test” Also, if the fallouts are concentrated in a specific group, such as the control or test group, the test itself may not derive significant results. For example, if 30 people were recruited for each group but 15 people from the test group leave due to COVID-19, the reliability of the test statistics may be undermined. Pharmaceutical companies have also had difficulty conducting bioequivalence tests in the early stages of the COVID-19 pandemic. In the early stages of the outbreak in 2020, the tests had been delayed with medical institutions discontinuing face-to-face work related to bioequivalence tests such as administration, screening, and monitoring. The main reason why pharmaceutical companies are expressing concern over their difficulties is because of the pressing deadline of the drug pricing re-evaluations for generic drugs. The Ministry of Health and Welfare announced a plan to re-evaluate the price ceiling of drugs, under which generics that do not meet the highest-price requirements in June 2020 are required to submit data on their ‘performance of bioequivalence tests’ and ‘use of registered APIs’ by February 28th, 2023 to maintain their previous drug price. This is a follow-up measure to apply the new drug pricing system which took effect in July 2020 to registered generic products. Under the revised drug pricing system, generic products can only be priced at the maximum price, which is 53.55% of the original drug’s price before patent expiry only when it satisfies both the requirements – directly-conducted bioequivalence tests and the use of registered raw materials. If either of the requirements is not met, the price cap is lowered by 15%. This means that a generic, which is approved by consigning the entire process to other companies without developing or producing it, will receive a drug price discount and be set at 72.25% of the previous price cap. The requirement of using a registered raw material can be met by switching the API. Due to the revised law, companies were left to decide between accepting the drug pricing discounts or maintaining the previous price by conducting bioequivalence tests. This is why companies have been actively conducting bioequivalence tests on their registered generics. According to the Ministry of Food and Drug Safety, a total of 768 plans for bioequivalence tests were approved in 1.8 years from July 2020 to February this year, which averages at 38 plans per month. Compared to 445 (22 per month on average) that were approved during the 1.8 years prior to July 2020 (November 2018 to June 2020), this is a 72.6% increase. Over half of the bioequivalence test plans approved recently are for registered generics. Of the 51 bioequivalence test plans approved in February, 39 were already on sale as registered generic products. Most of the bioequivalence tests are being conducted for ‘'in-house conversion' of the generics to manufacture in their own companies. If the companies make generics through formulation research and conduct bioequivalence tests that demonstrate bioequivalence, the companies can avoid the price cuts by obtaining change approvals. If companies convert consigned manufacturing to in-house manufacturing while applying for license changes, the companies can satisfy the ‘conducting bioequivalence test’ condition. Whichever way, it is said that it takes up to six months or more for bioequivalence tests to be imitated and render results. However, if the bioequivalence test data cannot be submitted by February next year due to a delay in the test schedules caused by the surge in confirmed COVID-19 cases, generic drugs will have no choice but to bear the drug price cuts. This means that the price of generic drugs may be reduced by 15%, even after the companies spent a lot of money and effort to avoid such discounts.
- Company
- GC Pharma’s Hunterase ICV approved for P1T in Korea
- by Kim, Jin-Gu Apr 08, 2022 06:08am
- On the 7th, GC Pharma announced that it had received approval for a Phase I trial of its severe Hunter syndrome treatment ‘Hunterase ICV’ in Korea from the Ministry of Food and Drug Safety. Hunterase ICV comes in a new formulation that is inserted as a device in the head, through which a drug is directly administered into a patient’s cerebral ventricle. It overcomes the limitations of existing IV-type formulations that were unable to penetrate the blood brain barrier (BBB) and reach the cerebral parenchyma. The clinical trial will be conducted in 3 institutions in Korea - the Samsun Medical Center, Seoul National University Hospital, and Pusan National University Yangsan Hospital – on 12 patients with a severe type of Hunter syndrome to evaluate the safety and efficacy of the drug. GC Pharma said that the unmet medical need is high in the area as 70% of the patients have the severe, neuropathic form of Hunter syndrome. An official from GC Pharma said, “We will continue our efforts to improve the quality of life of our rare disease patients. As the product has already been successfully commercialized abroad, we will make the best effort so that the drug could be supplied to our patients in Korea as soon as possible.” GC Pharma received marketing authorization for ‘Hunterase ICV,’ the world’s first treatment for sever-type Hunter syndrome in Japan in January last year. In a clinical trial conducted in Japan, "Hunterase ICV" significantly reduced ‘heparan sulfate (HS),’ a key substance that causes central nerve damage, and demonstrated an effect in maintaining and improving the developmental age.
- Company
- Yuhan's gastric atony tx has completed the registration
- by Nho, Byung Chul Apr 08, 2022 06:08am
- Yuhan Corporation (CEO Cho Wook-je) announced on the 6th that it has completed the first patient registration in phase 2A of clinical trial for patients with gastric atony of the new drug candidate "YH12852 (PCS12852)" exported by Technology to Processa Pharmaceuticals. Gastric atony is a chronic gastric motor disorder that causes severe heartburn, nausea, vomiting, and bloating due to delayed gastric emptying. In the United States, millions of patients suffer from dysentery, and there is a high demand for more effective treatment development. Currently, the only FDA-approved gastric atony treatment is Metoclopramide, a dopamine D2 receptor antagonist. However, the drug has been approved only for diabatic gastric atony and has a limited duration of up to 12 weeks due to serious potential side effects. Although past 5-HT4 agonists are effective, they bind non-selectively to other 5-HT receptors, resulting in serious side effects. YH12852 developed by Yuhan shows more than 200 times higher binding power to 5-HT4 receptors than other 5-HT receptors and has excellent selectivity and efficacy. Preclinical and clinical studies using YH12852 also showed minimal side effects in effective doses, so more clinical results are expected. Dr. Sian Bigora, head of development at Processa Pharmaceuticals, said, "We expect that this clinical 2A will have a similar effect on the gastric emptying rate of patients with gastric atony, as we confirmed that the gastrostomy rate was significantly improved while using YH12852 for constipation patients." He said, "The results of this study will provide important data to confirm the effect of YH12852 on the symptoms of patients with idiopathic and diabatic gastric atony, and will be useful for further designing clinical phase 2B." This clinical trial is a phase 2A clinical trial aimed at evaluating safety, pharmacokinetic properties, and efficacy of 13C-Spirulina Gastric Emptying Breath Test (GEBT) according to the dose of YH12852 in moderate or severe gastric atony patients, and will be conducted in a total of 24 patients in the U.S.
- Company
- Organon Korea "No NDPA detected in Singulair”
- by Apr 07, 2022 06:10am
- Organon Korea announced on the 6th that no impurities were detected in ‘montelukast,’ the active ingredient of the allergic rhinitis and asthma treatment ‘Singulair.’ Organon Korea had conducted an impurity investigation for N- nitrosodipropylamine (NDPA) in January after the Ministry of Food and Drug Safety ordered companies to investigate the possibility of impurities. The company had brought in the active pharmaceutical ingredient used for the manufacture of Singulair for investigations in Korea. The company used a liquid chromatography-mass spectrometry device (LC-MS/MS) that could detect minimal amounts of the impurity. The results of the investigation and assessment data will be submitted to the MFDS soon. NDPA is a type of nitrosamine impurity that can be formed in the presence of amines or amine sources together with nitrite or nitrite equivalent reagents. The company explained, "The process was not included in the montelukast synthesis process, and it was found that there is no possibility of cross-contamination in the final manufacturing process." The company had also reached the same conclusion in an impurity investigation conducted at the request of the European Medicines Agency (EMA) in 2019. Keon-Young Jung, Managing Director of Marketing at Organon, said, “Organon Korea has confirmed the safety of its products from impurities through evaluation of the manufacturing process and quantitative analysis on the API of all its formulations. We hope that the tests will help HCPs and patients to resolve concerns about impurities in the original Singulair.”
- Company
- Competition for Pelubi's generics worth ₩30 billion
- by Kim, Jin-Gu Apr 07, 2022 06:10am
- Pelubi It is expected that generic competition will take place in earnest in the Pelubi market, a osteoarthritis treatment worth 30 billion won per year. Following Youngjin Pharmaceutical, which launched generic alone, Huons and Chong Kun Dang are predicting their entry into the market. Daewon Pharmaceutical, which faces the challenge of generic, is in a situation where it is confronting each other by releasing follow-up drugs such as original formulation change and salt change products. ◆Generic for exclusivity of first generics ends According to the pharmaceutical industry on the 6th, the period of Youngjin's Pelubi will end on the 25th of this month. Phelps is the first generic of Daewon Pharmaceutical. Youngjin Pharmaceutical received generic for exclusivity. Accordingly, except for Youngjin Pharmaceutical, the other generic companies were not able to release the same-active ingredients within the generic for exclusivity period. Huons and Chong Kun Dang are expected to release Generics in earnest when Phelps' priority sales period expires on the 25th of this month. Like Youngjin Pharmaceutical, the two companies have surpassed patent of Pelubi. In April and May last year, generics for Pelubi received product approval, respectively. Huons has already received insurance benefits. When generic for exclusivity expires, generic can be released immediately within this month. Daewon Pharmaceutical, the original company, is developing strategies such as developing follow-up drugs and adding indications. Daewon Pharmaceutical plans to release Pelubi S, which was approved as a salt-changing product last year, soon. Daewon Pharmaceutical explained that it improved drug solubility and side effects of GI disorders through salt changes. In the case of Pelubi SR, which was released earlier, it already has more performance than Pelubi. According to UBIST, a pharmaceutical market research firm, Pelubi and Pelubi SR's outpatient prescriptions amounted to 32.5 billion won last year. Among them, Pelubi SR's prescription performance is said to account for about 70% of the total. It is analyzed that the addition of indications had a significant impact on the expansion of Pelubi SR's prescription performance. Daewon Pharmaceutical added "post-traumatic pain" as an indication of Pelubi SR in May 2020. It is an indication that Pelubi does not have. ◆ Unfinished patent dispute, Pelubi SR's New Patent Challenge Variables There are two main variables of generic competition in Pelubiprofen market in the future. One is the Pelubi patent dispute. Youngjin Pharmaceutical, Huons, and Chong Kun Dang won in the first trial, but Daewon Pharmaceutical objected to the decision. If Daewon Pharmaceutical wins, sales of Pelubi generic will be discontinued. Generics companies are also forced to compensate for damages caused by patent infringement is inevitable. There is a possibility that Daewon Pharmaceutical's delayed drug price reduction may be executed according to the subsequent ruling. Daewon Pharmaceutical filed a lawsuit with the Seoul Administrative Court to cancel the drug price reduction, dragging the patent dispute against Pelubi to the second trial. If Daewon Pharmaceutical loses in the second trial, the drug price of Pelubi will be reduced by 30%. Another variable is the new patent challenge for Pelubi SR. With Pelubi SR performing more than Pelubi, Huons, Chong Kun Dang, and Mothers are reportedly preparing to challenge composition patent of Pelubi SR . Mothers Pharmaceutical has already begun BA test of generics for Pelubi SR. Mothers Pharmaceutical was approved by the MFDS in July 2020 for a clinical trial for BA evaluation of Pelubi SR and Pelum SR.
