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- 2025-12-25 01:07:40
- Company
- 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.
- Company
- 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."
- Company
- The flu is going around in the southern hemisphere
- by Whang, byung-woo Jun 27, 2022 05:57am
- Concerns are growing that the influenza epidemic may begin as the COVID-19 pandemic turns into an endemic and social distancing such as lifting outdoor masks is eased. As the flu is showing signs of a full-fledged epidemic in Australia, one of the southern hemisphere countries that uses the flu as an indicator of the flu epidemic in the second half of the year, concerns are also being raised. It is pointed out that it is necessary to prepare countermeasures as the flu vaccination rate has fallen due to the influence of the COVID-19 pandemic over the past two years, and there may be repercussions from the release of masks. In the case of the flu epidemic, the epidemic scenario in the northern hemisphere is often calculated based on the situation in the southern hemisphere in the first half of the year. As winter comes first in the southern hemisphere, it is to guess the trend of infectious diseases. According to the Australian Influenza Surveillance Report (AISR), published biweekly by the Department of Health, the number of patients with flu symptoms in Australia has increased since March this year. In May, Australia's medical institutions confirmed influenza viruses in samples such as patient sputum and runny nose and reported more than 25,000 cases to the Ministry of Health per week, and by early June, 87,989 cases were reported to Australia's NNDSS, of which 47,860 occurred in late May and early June. This is a rapid increase compared to data from the past five years, and the gap is wider considering that the flu epidemic has not occurred due to COVID-19 in the past two years. In the end, it is pointed out that the same phenomenon may occur during the domestic flu epidemic in the second half of the year. Jung, Ki-seok, a professor of respiratory medicine at Hallym University Sungsim Hospital, said, "I don't know how much more exchanges between countries will occur in the second half, but I think the domestic flu will be the same." He said, "It is also difficult to predict the presence or absence of new mutations in COVID-19, but I think it is highly likely to be prevalent once more." Choi Young-joon, general director of the KSPID (Korea University's Department of Pediatrics and Adolescents), also said, "We say that the epidemic will be this year because we haven't caught much flu over the past two years," adding, "There has been no local transmission and there is a high possibility of infection." Companies such as Pfizer and Moderna have started to develop Combo vaccines that inoculate flu vaccines and COVID-19 vaccines at once, but as they have not yet succeeded in developing them, it is also the best countermeasure to plan individual vaccination plans at this stage. During the COVID-19 pandemic, the number of vaccinations increased significantly due to concerns over twin-demic during the 2020 vaccination period, but the site explained that NIP-oriented flu vaccinations were made in 2021. Vice Chairman of the KIES Shin Kwang-chul said, "In 2020, I have been vaccinated the most and I remember securing as many flu vaccines as possible," adding, "But last year, we set the demand for flu vaccines low enough to order only 30% of the quantity in 2020." With the possibility of a flu epidemic, companies that produce flu vaccines are also getting busy. As SK Bioscience has not produced a flu vaccine this year following last year, domestic companies and multinational pharmaceutical companies are filling it up. Sanofi Pasteur has already submitted to supply 2.2 million doses per dose at 10, 433 won per dose in connection with the procurement of the national vaccination (free flu vaccine vaccination project) for influenza vaccines, and has been selected as the top priority. 3 million doses of flu vaccine for Ilyang Pharmaceutical, which previously included NIP, are expected to be vaccinated in the private market. Already on the 18th of last month, U.S. health authorities began discussing ways to vaccinate flu and coronavirus at the same time in preparation for the simultaneous spread of COVID-19 and flu in winter. There are negative opinions due to concerns over the stability of vaccinating two vaccines, but we cannot ignore the situation in which twin-demise will occur. Domestic experts also say that it is necessary to consider temporarily expanding the scope of NIP as well as vaccinating COVID-19 and flu vaccines at the same time. Professor Jeong said, "There will be no big problem because the guidelines have already been set for inoculating two types of vaccines with one arm on each side." "If the flu vaccine epidemic is expected, we think it will be necessary to think about expanding the NIP range as we did before," he said.
- Company
- Sanofi’s Allegra dominates OTC·ETC drug market
- by Nho, Byung Chul Jun 24, 2022 05:46am
- The market for OTCs and ETCs of the antihistamine ingredient fexofenadine hydrochloride has been showing stagnant performance with its sales making a rectangle pattern for several years now. The market is virtually monopolized by the original drug, Sanofi’s Allegra Tab., with the total market estimated to be in the ₩8 billion range. One aspect to note is that the high-dose 120mg Allegra Tab. is listed for reimbursement as an OTC, and the other 180·60·30mg strengths of Allegra are distributed and prescribed as ETCs in Korea. This is analyzed as a strategic decision made by the company in consideration of the clinical protocol, design, and efficacy of its drug. Allegra is in the undisputed lead among fexofenadine hydrochloride OTCs, showing a vendor performance of ₩2-3 billion. Hanmi Pharmaceutical's Fexonadine, Huon’s Allerdin, and Chong Kun Dang’s Pecsone 120mg had sold ₩350 million, ₩150 million, and 120 million each, respectively. These latecomers were all released around 2005 and 2008, and all three drugs are all listed at ₩226 per tablet. The price of Sanofi’s finished imported pharmaceutical, the OTC Allegra, has been discounted to ₩225/tablet in 2017, ₩224/tablet in 2018, then to ₩222 in 2022, and is currently sold at a lower price than its domestic latecomers. Allegra and other OTC drugs with identical APIs that are effective in alleviating symptoms of allergic rhinitis are recommended to be administered with caution in patients with kidney failure, cardiovascular disease, or old age, and require particular medication guidance on the pharmacist’s part. In addition, its related ingredients are classified as pregnancy risk category C, and are used when there is a clear clinical basis or reason for its inevitable use. In the fexofenadine hydrochloride ETC market, the original, Sanofi’s Allegra and its bioequivalent, Hanmi Pharmaceutical’s Fexonadine are in a two-way battle. Allegra 180mg sold ₩3.1 billion, Fexonadine 180mg ₩870 million last year, and Allegra 30mg ₩240 million, Fexonadine 30mg ₩140 million. The 180mg strength of Allegra that was approved in 2000 is used to treat allergic dermatitis, and its price had been reduced to ₩314/tablet in 2017, ₩313/tablet in 2018, ₩312/tablet in 2020, and then to ₩311/tablet in 2022. The price of Allegra 60mg is currently set at ₩181/tablet and is effective in relieving symptoms of seasonal allergic rhinitis. According to the insert paper, etc. patients with hypertension, diabetic kidney disease, hyperthyroidism, and benign prostatic hyperplasia are requested to consult with their doctor, dentist, or pharmacist before taking the drug. Allegra 30mg, which is priced at ₩91/tablet, is prescribed to relieve symptoms of seasonal allergic rhinitis and allergic dermatitis. Hanmi Pharmaceutical’s Fexonadine 30mg, which was approved as a bioequivalence-assured product in 2007 is listed at ₩91/tablet, at the same price as the original drug. Meanwhile, one point of interest is in their distribution. The distribution of Allegra is dualized so that the OTCs are directly managed by Sanofi while the ETCs are imported and sold by Handok Pharmaceuticals.
- Company
- Yuhan’s new lung cancer drug Leclaza shows OS benefit
- by Nho, Byung Chul Jun 24, 2022 05:46am
- Yuhan Corp (CEO and President Wook Je Cho) announced on the 23rd that it had confirmed the overall survival (OS) benefit of Leclaza (lasertinib) in the Phase I/II LASER201 trial (NCT03046992). Leclaza is a treatment for epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC). Leclaza is a third-generation oral EGFR Tyrosine Kinase Inhibitor (TKI) that has high selectivity against the EGFR T790M resistant mutation. The drug showed superior efficacy and safety in NSCLC patients with brain metastasis as it can pass through the blood-brain-barrier (BBB). Lecalza’s OS results had been presented at the AOS 2022 & KCA Annual Meeting 2022 which was held from the 16th to 18th of this month. The OS results were updated from the Phase I/II LASER201 trial that had been the basis for Leclaza’s approval in Korea. The Phase I/II trial evaluated the efficacy and safety of continuous daily oral administration of Leclaza 240mg on 78 adult patients with EGFR mutation-positive NSCLC whose disease had progressed after EGFR TKI at 17 centers in Korea. Analysis results on the 76 patients with EGFR T790M mutation-positive patients showed that the median overall survival (mOS) was 38.9 months. Ji-Youn Han, Professor of Hemato -Oncology at the National Cancer Center who presented Leclaza’s OS results at the AOS 2022 & KCA Annual Meeting 2022, said, “It is encouraging that the mOS of EGFR T790M mutation-positive patients who are at high risk of brain metastasis had reached 38.9 months in the study, showing over 3 years of survival. Also, Leclaza is associated with the superior effect of achieving median intracranial progression-free survival (mPFS) of 26 months in patients with measurable brain lesions (25 patients).” Han added, “When considering that the ultimate treatment goal of treating cancer patients is in extending life, the OS benefit identified in the trial shows potential to extend life expectancy in T790M mutation-positive patients.” Meanwhile, the latest results of the Phase I/II LASER201 trial had previously been published in the April edition of the Journal of Thoracic Oncology (JTO), the official journal of the International Association for the Study of Lung Cancer (IASLC). Yeol-Hong Kim, Professor of Hemato Oncology at Korea University Anam Hospital, who is also the President of the Asian Oncology Society, said, “It is meaningful that Leclaza’s OS benefit had been presented at the AOS 2022 & KCA Annual Meeting 2022. The fact that Leclaza, a novel homegrown lung cancer drug, has demonstrated an mOS of 38.9 months in the second-line treatment of EGFR mutation-positive NSCLC is remarkable. The results show the possibility that Leclaza could bring a new turning point to the lung cancer treatment landscape in the future.” Wook Je Cho, CEO of Yuhan Corp, said, “We are pleased to share the news that Leclaza showed an OS benefit that meets the expectations as a novel homegrown lung cancer drug. Yuhan Corp will continue to make efforts, including completing the ongoing clinical trials and global commercialization so that Leclaza can become a useful treatment option for patients suffering from EGFR mutation-positive NSCLC in Korea and around the globe. Meanwhile, Yuhan is currently conducting a multinational Phase III trial (LASER 301) to evaluate the efficacy and safety of Leclaza as a first-line treatment in patients with EGFR mutation-positive NSCLC, and the top-line results of the Phase III trial are expected to be disclosed by the end of this year. A global Phase III trial on the combination of Leclaza with amivantamab, Janssen’s fully human bispecific antibody targeting both EGFR and MET, is also in progress.
- Company
- LG Chem’s Zemiglo+Forxiga combo Zemidapa is approved
- by Chon, Seung-Hyun Jun 23, 2022 05:50am
- LG Chem made a public announcement on the 22nd that the company had received marketing authorization for its type 2 diabetes treatment ‘Zemidapa Tab’ from the Ministry of Food and Drug Safety. The drug is a fixed-dose combination of the antidiabetic drug gemigliptin and dapagliflozin. Gemigliptin is an active ingredient of "Zemiglo," a new DPP-4 inhibitor antidiabetic that was developed by LG Chem. Dapagliflozin is the generic name of AstraZeneca’s SLGT-2 inhibitor, "Forxiga." Zemidapa is the third combination drug made using Zemiglo. LG Chem also owns two other drugs, including ‘Zemimet’ which combines Zemiglo with the antidiabetic drug metformin, and ‘Zemiro’ which combines Zemiglo with the hyperlipidemia drug rosuvastatin, in the market. LG Chem said, “We expect to continue on our current leadership in the diabetes treatment market in Korea with the development of a gemigliptin and dapagliflozin combination that improves the convenience and medication compliance of patients who used to take the two drugs separately as a combination therapy.”
