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- 2026-03-16 23:45:11
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- Tdap vaccine Adacel can be prescribed in general hospitals
- by Eo, Yun-Ho Jun 30, 2022 05:53am
- Sanofi Pasteur's new Tdap vaccine Adacel can be prescribed in general hospitals. According to related industries, the Tdap vaccine for teenagers and adults aged 11 or older has passed the DC of 100 medical institutions, including Seoul National University Hospital, Korea University Guro Hospital, Gangbuk Samsung Hospital, and Hallym University Gangnam Sacred Heart Hospital. As GSK's supply of Boostrix was suspended last year, additional prescriptions have recently been carried out rapidly. Adacel is a booster vaccine against pertussis by adding five preventive ingredients for pertussis to the existing Td vaccine that prevents diphtheria and tetanus. Re-vaccination of the DTap vaccine is recommended 5 years after the last Td vaccine, and it was found that the local side effects did not increase even if Adacel was vaccinated 2 years after the last Td vaccine. DTap vaccine is recommended to be vaccinated five times from 2 months old to 4 to 6 years old, and after that, it is recommended to be vaccinated once every 10 years from the age of 11 to 12. The number of cases of pertussis has increased since the 2000s in developed countries with high vaccination rates, increasing the need for additional vaccinations. According to U.S. CDC data, 75% of pertussis, especially in newborns, is known to be transmitted through family members, including parents. GSK announced at the end of last year that the supply of vaccines such as Rotarix, Cervarix, Synflorix, Menveo, Havrix, Priorix (MMR vaccine), Boostrix (Tdap vaccine), Infanrix-IPV, IPV/Hib (DTaP vaccine) was suspended. It is known that there was a document error in CTD. GSK added that it would resume shipping after submitting supplementary documents to the MFDS as it was a document error, not a quality issue.
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- 16 companies including Amgen launch industrial union
- by Eo, Yun-Ho Jun 30, 2022 05:52am
- A new confederation of unions centered around multinational pharmaceutical companies is soon to be launched in Korea. According to industry sources, a National Pharmaceutical & Bio Labor Union (NPU) under the Federation of Korean Trade Unions will be launched on July 5th. Labor unions of 16 companies, including labor unions from Korean subsidiaries of MNCs like Novo Nordisk, Bayer, Amgen, Novartis, Viatris, Janssen, Pfizer (will transition to industrial union), and those of Sanofi-Aventis, Alvogen, Opella Healthcare, Merck, Boehringer Ingelheim, AstraZeneca, GSK, and Hyundai Pharm will become affiliated with NPU. According to NPU, many multinational pharmaceutical companies are actively planning company restructurings that include layoffs despite preserving their continuous sales growth in the COVID-19 crisis, and the domestic pharma-bio industry has also been going against the market growth and is deteriorating the working condition of its workers. Therefore, the NPU plans to actively engage in ongoing disputes of member unions while strongly responding to the restructuring that is expected in some companies. Deok-Hwan Ahn, Chairman of NPU, said, “We will work to set a standard for the wages and welfare of workers in the pharmaceutical and bio-industry and work in solidarity to respond to common issues that arise in the industry to guide the direction of our industrial union" The launch ceremony for the new industrial union will be held from 11:00 a.m. on July 5th, in the 6th-floor main conference room of the Federation of Korean Trade Unions Building. Meanwhile, many labor unions from Korean subsidiaries of multinational pharmaceutical companies that have left the Korea Democratic Pharmaceutical Union, the representative industrial labor union of multinational pharmaceutical companies, have joined NPU.
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- 2nd P-CAB Fexclu to be released into the 800 bil market
- by Chon, Seung-Hyun Jun 30, 2022 05:52am
- Daewoong Pharmaceutical’s new drug, ‘Fexclu’ will be released next month. The industry’s eyes are on whether the drug will raise a storm in the PPI class and P-CAB class antiulcer medication prescription market that is estimated to be worth over ₩800 billion. The industry is also eyeing competition between Fexclu and K-CAB abroad. ◆Fexclu to be applied reimbursement from next month… prepares to target the ₩800 billion PPI·P-CAB market According to industry sources on the 29th, Daewoong Pharmaceutical’s Fexclu will be listed for NHI reimbursement starting next month. With the reimbursement approval, the drug will be released in the market 6 months after it received approval on December 30th. Fexclu’s insurance price cap was set at ₩939, which is 27.8% cheaper than its same-class drug K-CAB (₩1,300) Fexclu is a P-CAB class drug that treats gastroesophageal reflux disease (GERD). The drug was approved for the indication of treating erosive gastroesophageal reflux disease (GERD). P-CAB class antiulcer drugs competitively bind to the proton pump and potassium ion located in the final stage of acid secretion from the stomach wall to inhibit gastric acid secretion. This class of drugs has quickly settled in the market since HK inno.N introduced its first P-CAB type of new drug ‘K-CAB’ in 2018. Fexclu will be mainly targeting the PPI class and P-CAB class antiulcer drug market, which raised ₩842.1 billion in prescriptions last year. The PPI class market made ₩732.5 billion and the P-CAB class market ₩109.6 billion last year. The industry sees a high possibility of Fexclu’s success in the market. K-CAB had already demonstrated the marketability of P-CAB class anticancer drugs during the past 3 years. According to UBIST, K-CAB had raised ₩109.6 billion in outpatient prescriptions 3 years into its release last year, which is the first time a single brand of a homegrown novel drug had made annual prescriptions exceeding ₩100 billion. K-CAB had created a sensation selling ₩30.9 billion in the first year of its release and has continued its rapid growth in 2020 and last year. K-CAB’s sales continued to grow due to its advantages - having a faster onset of action than PPIs, is allowed to be taken regardless of meal ingestion, demonstrating superior symptom improvement, and showing longer-lasting night-time gastric acid suppression. With HCPs and patients in the field already showing high satisfaction with P-CAB class antiulcer medications using K-CAB, Fexclu is expected to make a relatively easier way into the market. Also, Fexclu’s insurance cap, which was set 30% lower than that of K-CAB may act as an advantage in the prescription market. However, K-CAB owns a total of 4 indications, rendering it difficult for Fesclu to completely replace K-CAB in the market. In addition to the treatment for erosive and non-erosive GERD, K-CAB sequentially secured additional indications as a combination therapy with an antibiotic for Helicobacter pylori eradication in patients with peptic ulcer or chronic atrophic gastritis. Among the indications, insurance reimbursement is applied to K-CAB for the treatment of GERD and stomach ulcers. Fexclu will also be targeting PPI-class drugs that account for the largest amount of the antiulcer drug market, as a significant amount of K-CAB prescriptions arise from patients who have switched to K-CAB from PPIs. Last year, the amount of outpatient prescriptions for PPI class drugs recorded ₩732.5 billion. This is a twofold increase in 5 years from the ₩372.4 billion in 2016 and is continuing to record high growth. ◆Fexclu·K-CAB accelerates entry to overseas market… competition in overseas performance of the two drugs also a point of interest The overseas market competition between Fexclu and K-CAB is also a point of interest. Daewoong Pharmaceuticals had signed 6 export agreements with 15 countries in North America, Latin America, China, Middle East to export Fexclu. In 2020, the company signed a contract with the Mexican pharmaceutical company Moksha8 and Brazil's EMS for the local marketing and sales rights of Fexclu and paved the way for Fexclu’s entry into Central and South America. In March last year, the company signed a $384.5 billion contract with China's Shanghai Haini Pharmaceutical. Status of Fexclu export agreements (Source: Daewoong Pharmaceutical)) In June last year, the company made a technology transfer agreement with U.S. company Neurogastrx and handed over the development, authorization, and sales rights of Fexclu in the US and Canada. Through the agreement, Daewoong Pharmaceutical secured a 5% stake in Neurogastrx as an upfront, non-refundable fee, and was assured up to $430 million in development, regulatory, and sales milestone payments. It then signed 2 additional export contracts to enter 10 countries in Central and South America and the Middle East. In total, Daewoong secured up to ₩1.2 trillion through export agreements for Fexclu. K-CAB has entered the market of a total of 34 countries through technology or finished product exports. HK Inno.N had first signed a technology export agreement with the Chinese company Shandong Luoxin Pharmaceutical in 2015. The deal was to receive $18.5 million in upfront payments and clinical development, regulatory, and sales milestone payments. The company estimated that the agreement amount would rise to $95.29 million with royalties incurred after the local commercialization of K-CAB. Also, HK InnoN signed an export agreement for the finished K-CAB product with the Mexican pharmaceutical company Laboratorios Carnot in February 2019 to export K-CAB to 17 countries in Central and South America. Its export amount, including supply price, has amounted to $84 million over the past decade. Exports agreements have been more actively made after K-CAB was released in Korea. In September 2019, contracts were signed to supply the finished drugs to Indonesia, Thailand, and the Philippines, and in 2020, export agreements were made to export K-CAB to Mongolia and Singapore. Last year, the company also signed export contracts with companies in Vietnam, Malaysia, the US, and Canada.
- Company
- Opdivo reattempts reimb in first-line gastric cancer
- by Eo, Yun-Ho Jun 29, 2022 05:54am
- The cancer immunotherapy drug Opdivo is reattempting reimbursement as a first-line treatment once more. According to industry sources, Ono Pharma Korea and BMS Korea’s PD-1 inhibiting cancer immunotherapy Opdivo (nivolumab) will be deliberated by the Cancer Disease Deliberation Committee (CDDC) of the Health Insurance Review and Assessment Service on the 28th. In Korea, Opdivo was approved ‘as first-line treatment in combination with fluoropyrimidine- and platinum-containing chemotherapy for advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma’ in June last year. With the added indication, the drug became the first and only domestically approved cancer immunotherapy for the first-line treatment of gastric cancer. Also, Opdivo’s unresectable malignant pleural mesothelioma indication will also be deliberated at the CDDC meeting. More specifically, Opdivo’s indications as ▲ first-line treatment of advanced or metastatic gastric adenocarcinoma, gastroesophageal junction cancer, and esophageal adenocarcinoma in combination with chemotherapy, and ▲ in combination with ‘Yervoy’ in unresectable malignant pleural mesothelioma will be deliberated at the CDDC meeting. In the CDDC meeting that was previously held in February, the committee decided not to set reimbursement standards for both indications. Therefore, whether Opdivo’s second attempt at reimbursement in gastric cancer will bear fruit remains to be seen. Gastric cancer is considered to be the field in most urgent need of extended reimbursement to immunotherapy drugs after lung cancer. As the most prevalent cancer and the fourth most common cause of cancer deaths in Korea, gastric cancer has a favorable survival rate when detected in its early stages but its relative survival rate drops to 5.9% with distant metastasis. In particular, the current stand of care for HER2-negative gastric cancer is chemotherapy due to the unavailability of new drugs approved for first-line treatment for the past decade. Opdivo has received attention as a viable alternative for these patients. Meanwhile, Opdivo’s efficacy in lung cancer was confirmed through the large-scale Phase III CheckMate-649 trial. The median overall survival (mOS) of patients was 13.8 months for all patients randomly assigned to receive Opdivo compared to the 11.6 months in the control group. In PD-L1 positive patients (CPS ≥ 5), the Opdivo combination group’s mOS was 14.4 months, which was a 29% reduction in risk compared to the 11.1 months of the control group. Also, Opdivo improved the overall response rate (ORR) by 12% in the all-randomized population, and by 15% in PD-L1 positive patients (CPS ≥ 5). The complete response (CR) rate was also higher for the Opdivo combination group in both the all-randomized population and PD-L1 positive patients.
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- Celltrion Stops Developing Inhalation-type COVID Antibody Tx
- by Kim, Jin-Gu Jun 29, 2022 05:53am
- Celltrion announced on the 28th that it will suspend phase 3 clinical trials of inhalation-type antibody treatments that were being developed as COVID-19 treatments. Celltrion explained the reason for the clinical suspension that the business feasibility of the COVID-19 treatment will be insignificant due to the difficult global clinical environment. Celltrion judged that the business feasibility would be insignificant as the number of phase 3 clinical patients required by global regulators is larger than expected amid the rapid transition of coronavirus to endemic diseases due to the global spread of Omicron subvariations and expansion of vaccinations. According to Celltrion, global regulators are avoiding "fast-track" procedures such as emergency approval in line with full-fledged entry into Endemic. Regulatory agencies are reportedly increasing the threshold as several global pharmaceutical companies have recently failed to prove their effectiveness due to weakening pathology in clinical trials of COVID-19 treatments for standard risk groups, not high-risk groups. Celltrion has previously completed phase 1 clinical trial of inhalation-type antibody treatments and approved a global phase 3 clinical trial plan for inhalation-type cocktail COVID-19 treatments, which added CT-P63, a candidate substance for COVID-19 treatments. However, Celltrion plans to closely monitor the current status of the COVID-19 pandemic in the future and continue to manage and research on the pool of COVID-19-responding cocktail candidates that have been built since the beginning of the pandemic. It will continue to study the development platform of mRNA vaccines and oral COVID-19 treatments that can prepare for future pandemics. Celltrion is developing oral COVID-19 treatment products under generic licenses secured at the group level to expand access to treatments in low- and middle-income countries, and aims to supply them early next year. An official from Celltrion said, "Celltrion has actively contributed to overcoming the global pandemic by focusing on the development of antibody treatments for the first time in Korea and supplying them at home and abroad, but the clinical and licensing environment of COVID-19 treatments is changing." He added, "We will reorganize the direction of developing COVID-19 treatments by watching international environmental changes in the face of an endemic transition, and focus on developing various pipelines currently facing clinical and permission."
- Company
- Patent challenge for gastritis drug Rebamipide expanded
- by Kim, Jin-Gu Jun 29, 2022 05:53am
- 30 generic companies participated in the patent dispute for Yuhan's acute and chronic gastritis treatment "Recomid SR." According to the pharmaceutical industry on the 24th, 20 pharmaceutical companies, including Kyung Dong, recently requested a passive judgment on the scope of rights to Recomid SR's patent. Prior to them, 13 pharmaceutical companies, including Mother's, also challenged the same patent. However, Dongkwang, Samjin, and Huons, which previously requested a patent trial, voluntarily withdrew. As a result, a total of 30 companies are challenging Recomid SR patents. Mother's are the first companies to file a claim as well as Kyung Dong, Nexpharm, Daewoong Bio, Dahannupharm, Dongkook, Dongwha, Litepharmtech, Vivozon, Samil, SCD, Sinil, CMG, Arlico, Alvogen Korea, HLB, Aprgen, YS, Withus, Unimed, Reyonpharm, Ilhwa, Genuonesciences, Joonghun, GLPharma, Pharmgen Science, BNC Korea, Korea Pharma, Hutecs, and Hanlim. The reason why 30 generic companies challenged the patent is that Recomid SR grew rapidly in the pharmaceutical industry. The drug was jointly developed by Yuhan Corporation, GC Pharma, Daewoong Pharmaceutical, and Daewon Pharmaceutical. It received permission in December 2020 and released the product at the same time in March last year. Yuhan Corporation will entrust the production of the remaining three companies. Patents are also in Yuhan Corporation. Recomid SR is taken twice a day. According to the MFDS, the combined production performance of the four companies reached 15 billion won in the 10 months since its release in March last year. Sales of Yuhan's Recomid SR is 5.8 billion won, GC Pharma's Mucotect SR is 4 billion won, Daewon Pharmaceutical's Bidreba SR is 2.9 billion won, and Daewoongs Mucotra SR is 2.4 billion won. In contrast, the combined production performance of the four existing products was only 3.7 billion won. The original pharmaceutical company for Rebamipide is Otsuka. In 1991, Mucosta was granted permission. Production of tablets last year was 16.7 billion won. On top of that, Otsuka was approved for Mucosta SR in January last year and released the product a month later than Yuhan Corporation. SR Product's performance last year was 3.5 billion won.
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- Kwangdong will sell GSK’s allergic rhinitis treatment
- by Chon, Seung-Hyun Jun 28, 2022 06:09am
- Kwangdong Pharmaceutical announced on the 27th that it has signed a sales partnership agreement with GSK for its allergic rhinitis treatment, ‘Avamys nasal spray.’ Avamys, which was granted marketing authorization in Korea in 2009 is a steroid nasal spray indicated for the treatment of seasonal and perennial (year-round) allergic rhinitis in people 2 years of age and older. It mainly helps reduce the symptoms of allergic rhinitis such as itchy eyes, nasal congestion, runny or itchy nose, etc., and may be prescribed at the doctor’s discretion in various departments including otolaryngology, internal medicine, and pediatrics. Avaymys contains the active substance fluticasone furoate 0.05g that is provided in a spray-type device that is easy to spray into the nasal cavity and may be sprayed up to 120 times. Its 24-hour relief of allergy symptoms is also considered one of its biggest conveniences. An official from Kwangdong Pharmaceutical said, “We have decided to expand our business relations based on the strong trust established between the two companies since 2015 when we began working with GSK for the sale and distribution of their vaccine. We hope to further contribute to improving the allergic rhinitis treatment environment for the suffering patients and HCPs with Avamys.”
- Company
- Oral SMA drug Evrysdi may be prescribed at general hospitals
- by Eo, Yun-Ho Jun 27, 2022 05:58am
- The oral spinal muscular atrophy (SMA) treatment ‘Evrysdi’ may be prescribed at general hospitals. According to industry sources, Roche Korea’s SMA treatment Evrysdi (risdiplam) passed the drug committee (DC) reviews of several medical institutions including Seoul National University Hospital. Evrysdi was first approved in Korea in November 2020 ‘to treat SMA in adults and children 2 months of age and older.’ In the US, its indication has recently been extended to cover infants less than 2 months of age. As the first oral option introduced in the field of SMA, Evrysdi has the advantage of allowing customization according to age and weight. However, its reimbursement listing process is making little progress. The drug applied for listing in July last year but had made no progress so far. Currently, Biogen’s ‘Spinraza (nusinersen)’ is listed for reimbursement in SMA, and Novartis’ Zolgensma (onasemnogene abeparvovec-xioi) is under drug pricing negotiations with the National Health Insurance Service. As Roche Korea may accept a relatively lower price for Evrysdi than the other high-priced drugs above, this reimbursement competition may also be worth attention in the future. Meanwhile, Evrysdi’s efficacy has been demonstrated through the FIREFISH trial conducted on infants from 2 months to 7 months of age, and the SUNFISH trial conducted on children and adults from 2 years to 25 years of age. In the SUNFISH trial on 180 Type 2 or 3 SMA patients, Evrysdi improved motor function at month 12, as measured by the Motor Function Measure 32 (MFM-32) score from baseline. Also, in the FIREFISH trial that was conducted on infants 2 to 7 months of age with Type 1 SMA, 88% of the patients that were administered Evrysdi for 2 years survived the 2 consecutive years without ventilator support. Based on the Bailey Infant Development Test (BSID-III) that measures infant development and motor activity, 59% of the infants that were administered Evrysdi were able to sit without support for at least 5 seconds. Also, 65% of the infants were able to control their neck for 1 year, 29% were able to turn on their buttocks, and 30% were able to stand with support.
- Company
- This time it’s acyclovir… impurity issue rises again
- by Chon, Seung-Hyun Jun 27, 2022 05:57am
- The drug impurity risk issue has spread to the antiviral acyclovir. According to the impurity issue that arose abroad, the health authorities have started making safety measures on pharmaceutical companies. According to industry sources on the 23rd, the Ministry of Food and Drug Safety has recently ordered pharmaceutical companies to conduct a review for N-nitrosodimethylamine (NDMA) impurities on finished drugs that contain acyclovir. The MFDS has ordered the companies to submit test results conducted on the companies’ representative batch numbers of the finished acyclovir products available on market. Products that are manufactured in below 3 batch numbers are required to submit test results of all batches This safety measure was made according to the safety information that finished tablet products containing acyclovir were recalled abroad due to excess NDMA impurities. The MFDS ordered companies to immediately report their test results after completion even before the impurity data submission deadline. Acyclovir is an antiviral used for the ‘treatment and prevention of initial and recurrent genital herpes, Herpes Simplex Virus Encephalitis, and Mucocutaneous Herpes Simplex Virus Infection’ as well as for the ‘treatment of herpes zoster (Shingles).’ Its annual outpatient prescriptions amount to 15 billion won a year. This is the first time an impurity issue arose in the area, and around 50 companies sell acyclovir tablets in Korea. With acyclovir, the total number of ingredients with new impurity risks increased to 3. The MFDS had previously requested pharmaceutical companies to investigate their montelukast imported and manufactured APIs and finished products for N-nitrosodipropylamin (NDPA) impurities and submit its results in January. In April, the MFDS had ordered pharmaceutical companies to submit data including the impurity test results and data on the possibility of N-Nitroso-Aryl Piperazine (NNAP) impurities in quetiapine products.
- Company
- Belvarafenib confirmed its safety & effectiveness
- by Chon, Seung-Hyun Jun 27, 2022 05:57am
- Major clinical results of Belvarafenib + Cobimetinib included in Roche corporate briefing dataA study showed that the new anticancer drug Belvarafenib, which Hanmi Pharmaceutical exported technology to Genentech, confirmed its safety and effectiveness overseas. According to Hanmi Pharmaceutical on the 22nd, Roche revealed the progress of clinical research on "Belvarafenib," which is being developed by its subsidiary Genentech, at a corporate briefing held during the recent ASCO event. Belvarafenib, which Hanmi Pharmaceutical exported to Genentech in 2016, is a targeted anticancer drug based on pan-RAF inhibitors. It acts as a mechanism to suppress RAF, a type of MAP kinase that mediates intracellular signaling. Hanmi Pharmaceutical received $80 million in a contract for the export of Belvarafenib technology. Roche introduced data on the efficacy and safety of patients with NRAS mutated melanoma identified as clinical trials (1b) for combined administration of Belvarafenib and Cobimetinib (MEK inhibitor) in 118 patients with different types of solid cancer with RAF or RAS mutations. According to the announcement, 26.3% of NRAS mutated melanoma patients administered belvarafenib and Cobimetinib showed partial response (PR), and 42.1% of patients reached stable lesion (SD). The median value of the total progression-free survival period (PFS) was 7.3 months. No new adverse reactions were observed beyond the safety of individual drugs. All patients who showed partial reactions were NRAS mutant melanoma patients with a history of treatment with Imune checkpoint inhibitor, and this result could show new hope for patients who recurred after Imune checkpoint inhibitor treatment, Hanmi Pharmaceutical explained. "Belvarafenib, developed by Hanmi Pharmaceutical, is a powerful selective RAF mutation inhibitor," said Andrew Chan, managing director of Genentech. "We confirmed its safety and anti-tumor effects when administered in combination with Cobimetinib in patients with NRAS mutated melanoma who previously received Imune checkpoint treatment." An official from Hanmi Pharmaceutical said, "Innovative anticancer drugs developed and exported by Hanmi Pharmaceutical are being developed smoothly based on close consultation with partners," adding, "We will focus more on R&D capabilities for rapid commercialization of various innovative drugs, including Belvarafenib."
