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- 2025-12-23 22:26:41
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- Celltrion discloses interim results of global phase 3 Eylea
- by Hwang, Jin-joon Apr 05, 2023 05:45am
- Researchers at Celltrion are researching candidate materials. (Photo by Celltrion)On the 3rd, Celltrion disclosed the interim results based on the 24th week of the global phase 3 clinical trial of CT-P42, an eye disease treatment Eylea biosimilar. Celltrion is conducting clinical trials for 52 weeks on 348 DME patients in 13 countries, including Germany and Spain. The interim results released this time are the results of clinical progress up to 24 weeks. Celltrion is conducting clinical trials by dividing it into two groups: the CT-P42 administration group and the original drug administration group. The primary endpoint is the change in BCVA value measured at week 8 from baseline. As a result of the measurement, CT-P42 satisfied the predefined equivalence criteria. Secondary evaluation indicators, such as efficacy, safety, and immunogenicity evaluation, showed similar trends to the original drugs. Celltrion plans to complete the remaining phase 3 clinical trials and apply for CT-P42 approval to major countries such as the US and Europe within this year. Eylea, the original drug of CT-P42, is a blockbuster eye disease treatment developed by Regeneron in the US. It is used as a treatment for DME and wAMD. Eylea's material patent is set to expire in June this year in the US and in May 2025 in Europe. As of last year, Eylia's global sales were $9.75699 million.
- Company
- CHMP gave a positive opinion on the approval of Soliris
- by Jung, Sae-Im Apr 05, 2023 05:44am
- On the 31st of last month, Samsung Bioepis announced that it had obtained a positive opinion for the item approval of 'EPYSQLITM (Eculizumab)', a treatment for rare diseases, from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA). EPYSQLITM is a biosimilar of Alexion's paroxysmal nocturnal hemoglobinuria (PNH) treatment 'Soliris'. It is an expensive drug with annual treatment costs of hundreds of millions of won, and its annual global sales reached 3.762 billion dollars (approximately 4.7 trillion won) last year. EPYSQLITM is the first product developed by Samsung Bioepis in the field of hematology. It is expected that it will be able to obtain official sales permission after the final review by the European Commission (EC), which usually takes about 2 to 3 months. Samsung Bioepis has currently commercialized a total of six biosimilar products in the European market. With the recommendation of EPYSQLITM permission, it has been able to diversify its business portfolio into hematology following autoimmune, oncology, and eye disease treatments. The company demonstrated pharmacokinetic equivalence between EPYSQLITM and the original drug through a phase 1 clinical trial conducted on healthy volunteers from November 2018 to March 2019. Then, from August 2019 to October 2021, a phase 3 study was conducted on patients with PNH to confirm clinical equivalence with the original drug. Samsung Bioepis has also carried out an extended supply of SB12 free of charge for up to two years to patients participating in the clinical trial, considering the burden of drug price for PNH treatment. An official from Samsung Bioepis said, "EPYSQLITM is a drug that can realize the essential meaning of biosimilar development by enabling improved patient accessibility of ultra-high-priced biopharmaceuticals," adding, "Providing more treatment opportunities for patients suffering from rare diseases. I will try to do it," he said.
- Company
- Hanmi internationally introduces 7 new drug candidates
- by Hwang, Jin-joon Apr 04, 2023 05:53am
- Hanmi Pharmaceutical unveils mRNA cancer vaccine and new targeted anticancer lead compound at AACR2023. (Photo AACR) Hanmi Pharmaceutical is revealing its messenger ribonucleic acid (mRNA) cancer vaccine and new targeted anticancer lead compounds. The company reinforced its anticancer pipeline by adding next-generation anticancer drug technologies and targets to its existing major anticancer drug pipeline that has been making smooth progress in preclinical trials. According to industry sources on the 2nd, Hanmi Pharmaceutical will be presenting 7 abstracts related to its anticancer pipeline at the American Association for Cancer Research (AACR) Annual Meeting 2023 held in Orlando, Florida from the 14th (local time) to the 19th. At AACR 2023, the company will unveil abstracts about 2 lead compounds in its new anticancer pipeline. One will be about enhancing antitumor activity by inhibiting the YAP/TAZ-TEAD that targets the Hippo pathway, and the other is about an mRNA cancer vaccine. Also, Hanmi Pharmaceutical will be making abstract presentations on how its novel SOS1 inhibitor, HM99462, demonstrates antitumor activity against KRAS-mutant cancers, how its EZH1/2 dual inhibitor HM97662 demonstrates antitumor activity in T-cell lymphoma, the effect of combining use of HM97662 with an immune checkpoint inhibitor, the antitumor effect of its IL-2analog, HM16390, and how BH3120, a bispecific antibody that targets the G-1BB and PD-L1 simultaneously, stimulates T cells in tumor tissue preferred manner. The published abstracts showed that Hanmi’s lead compounds that target the Hippo pathway exhibited dose-dependent growth inhibitory effects in Hippo pathway-altered cancer cell lines. Its safety profile was also confirmed in vitro. Hanmi’s lead compounds that target the Hippo pathway also showed effective tumor growth inhibition activity within tolerable doses in cancer cell xenograft mouse models. The company plans to initiate preclinical studies after establishing a candidate substance for a preclinical study. In addition to the lead compound for the new anticancer drug that targets the Hippo pathway, Hanmi Pharmaceutical also disclosed the results of preclinical studies related to 4 candidates in its major pipeline through abstracts in advance. According to the abstracts, the SOS1 inhibitor HM99462 showed effective tumor growth inhibition activity within tolerable doses when administered alone in cancer cell xenograft mouse models harboring various KRAS mutations. Also, the combination of HM99462 with KRAS G12C or MEK inhibitors led to synergistic anti-tumor activity in both in vitro and in vivo models. HM99462 is currently in IND enabling GLP-toxicity studies and is palnning to initiate a clinical study in early 2024. At the meeting, Hanmi Pharmaceutical also disclosed the antitumor activity of HM97662 in T-cell lymphoma. The enhancer of zeste homology 2 (EZH2) and its homolog EZH1 are types of enzymes known to induce solid cancers like blood cancer. Hanmi confirmed the tumor growth inhibition effect of oral administration of HM97662 in EZH1/2 co-expressed lymphoma cell mouse xenograft model. The company also presented two papers on preclinical studies conducted on its IL-2 analog, HM16390. After administering HM16390 once a week for two weeks in mouse models with melanoma, complete response (CR) was observed in 89% and 100% of the mice at 2.1mg/kg and 8.5 mg/kg, respectively. The median overall survival was also dose-dependently prolonged median overall survival from 15 to 38 days at the dose range of 0.34 to 42 mg/kg. Also, in mouse models with melanoma, the combined use of HM16390 with PD-1 targeted immune checkpoint inhibitors once a week for 4 weeks, CR was increased from 22% with monotherapy to 88% with combination therapy. In addition, Hanmi’s Chinese subsidiary, Beijing Hanmi Pharm disclosed preclinical study results of its bispecific antibody that is designed to target two different targets imultaneously with the Pentambody™ platform. Pentambody is a next-generation, bispecific antibody platform technology that allows one antibody to bind to two different targets simultaneously. Beijing Hanmi Pharm confirmed that BH3120 showed strong antitumor efficacy in multiple tumor models, and that the combination of BH3120 with a PD-1 antagonist showed synergic effects of continuing to activate the T-cells while reducing immune-related side effects. In he toxicology studies conducted so far with cynomolgus monkeys, the No Observed Adverse Effect Level (NOAEL) of BH3120 was determined to be 200 mg/kg. Abstracts of preclinical studies related to mRNA cancer vaccines have not yet been published. The contents that will soon be disclosed are the preclinical results of a clinical study suppressing tumor growth in a KRAS mutant LL/2 mouse model using a multi-target mRNA-based cancer vaccine. Previously, Hanmi Pharmaceutical announced that it had successfully developed its own mRNA platform at the JP Morgan Healthcare Conference 2022 held in January last year. In addition to developing a COVID-19 vaccine, the company has been promoting the application of the mRNA platform in the fields of metabolic diseases, anticancer, cardiovascular and renal diseases, enzyme replacement therapy, etc.
- Company
- Medytox paid service fees of KRW 97.7B in 4 years
- by Kim, Jin-Gu Apr 04, 2023 05:52am
- The service fees paid out by Medytox during the past 4 years have reached nearly KRW 100 billion. Since 2019, disputes related to botulinum toxin had risen simultaneously in the United States and Korea, which led to an increase in the litigation costs and fees the company has spent. The amount of annual service fee payouts decreased after the legal dispute in the US ended with a settlement, but with the risk of litigation in Korea and abroad still unresolved, the company has been spending more than KRW 15 billion a year in litigation fees. ◆Company paid KRW 97.7 billion for 4 years since 2019 as service fees due to a surge in litigation costs According to the Financial Supervisory Service on the 4th, Medytox paid out KRW 16.1 billion as service fees last year. Its fees, which were around KRW 6.6 billion in 2018, had risen over fivefold to KRW 35.1 billion by 2019. Then, a total of 97.7 billion won was paid out during the 4 years that followed, including KRW 29.7 billion in 2020, KRW 16.8 billion in 2021, then KRW 16.1 billion last year. A sizeable amount of the fees Medytox paid out were legal costs. In general, litigation costs of a company are included as service fees under Selling, General, and Administrative expenses in financial statements. In addition to litigation costs, the service fee includes royalties, accounting advisory fees, royalties for using patent rights, and credit card payment fees. Medytox The sharp increase in service fees paid out by Medytox coincides with the time when the company's botulinum toxin dispute in the United States began in earnest. In January 2019, Medytox filed a lawsuit against Daewoong Pharmaceutical and Daewoong Pharmaceutical's US partner Evolus, to the US International Trade Commission (ITC) for infringement of trade secrets. The intensified dispute over botulinum toxin raised the company’s litigation expense, and as a result, the service fees paid for the 4 years alone reached near KRW 100 billion. This is 13% of Medytox's sales of KRW 726.7 billion that it had earned during the same period. Also, it is more than the combined operating profit of 4 years (KRW 69.8 billion). ◆ Fees decreased due to the settlement of the U..S dispute... 'Litigation risk' still remains Medytox's service fees have been decreasing since the company settled the ITC dispute in the US in early 2021. However, compared to 2018, which was before the various legal dispute began in earnest, the service fee payments the company is paying out are still more than double compared to before. The industry expects the service fees of over KRW 10 billion may be inevitable for a while as the litigation risk against Medytox has not yet been completely dissolved. Medytox is currently embroiled in more than 4 legal disputes. The first is the domestic civil lawsuit against Daewoong Pharmaceutical that remains unclosed. Medytox won the first trial in the civil lawsuit earlier this year, but Daewoong Pharmaceutical appealed. Given that the two sides are in a tense confrontation, the case is highly likely to continue on and be tried by the Supreme Court. Also, the company filed an administrative lawsuit claiming that the disposition that canceled the license was unfair Against the Ministry of Food and Drug Safety. In 2020, the MFDS has decided to cancel the license of Medytox products one after another, and Medytox filed a lawsuit to cancel the disposition. In addition, the Seoul Western District Prosecutors' Office indicted 6 botulinum toxin companies including Medytox for being in violation of the Pharmaceutical Affairs Act. They were accused of selling to domestic exporters without obtaining approval for national lot release from the MFDS. A legal dispute is also ongoing with its Chinese partner. Medytox officially announced that Gentix Ltd., a subsidiary of the Chinese company Bloomage Biotechnology, had filed a claim for damages against Medytox with the Singapore International Arbitration Centre (SIAC) earlier this year. The amount claimed for damages was HKD 750 million (approximately KRW 118.8 billion). The company had established Medybloom China with Bloomage Biotechnology in 2015 to prepare entry into the Chinese market. Medytox had planned to sell its botulinum toxin product to the Chinese market through the newly established company. However, the plan was put to a halt in July last year with Bloomage announcing intentions to terminate its cooperative relationship with Medytox. At the time, Bloomage is said to have pointed to how Medytox did not supply products for sale as the reason for termination.
- Company
- Pharma companies face the crisis ‘head-on'
- by Chon, Seung-Hyun Apr 03, 2023 05:49am
- The major listed pharmaceutical and bio companies were found to have significantly increased their R&D personnel over the past 3 years, during the COVID-19 pandemic. 9 out of 10 companies increased their research personnel, and the number increased by 25% during the past 3 years. According to the Financial Supervisory Service on the 31st, the total number of research personnel in major listed companies in Korea increased by 11.7% from the previous year to reach 6,417. Among the listed biopharmaceutical companies, the 30 with the highest sales that own research personnel were reviewed for research. Compared to before the COVID-19 outbreak, pharmaceutical companies in Korea have greatly increased the number of their R&D personnel. The number of researchers at 30 pharmaceutical companies increased by 4.2% from 5,122 in 2019 to 5,339 in 2020. In 2021, the number increased by 7.6% to reach 5,747, and the rate of increase was even greater last year. Over the past 3 years, the number of research personnel at the companies increased by 25.3%. R&D personnel at major listed pharma and bio companies (Unit: persons, Data: FSS) The numbers signify the companies' active investment in R&D personnel for new substances amid the unstable environment from COVID-19. The R&D investment amount of 30 major pharmaceutical and bio companies increased by 42.2% from KRW 1.917 trillion to KRW 2.726 trillion in 3 years. The number of R&D personnel increased in 26 of the 30 companies during the past 3 years. In other words, 9 of 10 companies had increased investments in R&D personnel. By individual company, Samsung Biologics’ R&D personnel increased by 354 over the past 3 years from 254 in 2019 to 608 last year. The number of R&D personnel at Samsung Biologics increased by 77 and 69 in 2020 and 2021, respectively, and then by 608 last year. R&D investments have also increased due to an increase in contract manufacturing organization (CMO) and contract development organization (CDO) orders for the comapny's biopharmaceutical drugs. Samsung Biologics recorded sales of KRW 3.00 trillion last year, and become the first company to exceed sales of KRW 2 trillion and 3 trillion at once among domestic pharmaceutical and bio companies. R&D investments by Samsung Biologics have increased more than fivefold in 3 years from KRW 48.5 billion in 2019 and reached KRW 268.2 billion last year. The number of R&D personnel at Daewoong Pharmaceutical was 379 last year, which is a 239 increase from 3 years ago. The number of R&D personnel at Daewoong Pharmaceutical increased from 140 in 2019 to 231 in 2020 when its personnel from its development unit were added to the count. The number then increased by 51 and 97 in 2021 and last year, respectively. The analysis is that the company has further strengthened R&D investments after making visible R&D achievements with Fexclu and Envlo. Daewoong Pharmaceutical's R&D investment increased by 43.2% from KRW 140.6 billion in 2019 to KRW 201.4 billion in 3 years. SK Bioscience's R&D personnel increased by 165 from 124 in 2019 to become 289 last year. SK Bioscience is one of the companies that received the most attention for developing a vaccine during the COVID-19 crisis. In June of last year, SK Bioscience became the first Korean company to successfully commercialize a homegrown COVID-19 vaccine, SkyCorione Multi Inj. SK Bioscience's R&D expenses soared 273.0% from KRW 30.3 billion in 2019 to KRW 113 billion last year. Based on last year, Yuhan Corp’s R&D personnel was 345, up 80 from the 265 it had had 3 years ago. Celltrion, Dong-A ST, and GC Pharma have increased the number of their R&D personnel by more than 70 over the past 3 years. In addition, Dongkook Pharmaceutical, Daewon Pharmaceutical, Huons, Kyongbo Pharmaceutical, and Shinpoong Pharmaceutical increased their R&D personnel by more than 20 over the past 3 years. As of last year, Celltrion had the largest size of R&D personnel with 721 researchers. Celltrion has 55 doctoral-level and 345 master's-level personnel conducting research in its Biotechnology Research Division, New Drug Research Division, Approval Division, Clinical Development Division, Medical Division, Chemical Product Development Division, etc. Samsung Biologics had hired 608 R&D personnel. The company is conducting research activities at MSAT BU, CDO Development Center, its Bio Research Center, etc. Among traditional pharmaceutical companies, Hanmi Pharmaceutical had the largest number of researchers with 584 researchers. Chong Kun Dang and GC Pharma hired more than 500 R&D personnel.
- Company
- Hugel appoints Seok-yong Cha, former CEO
- by Lee, Seok-Jun Apr 03, 2023 05:49am
- Hugel announced on the 31st that the 22nd regular general meeting of shareholders and board of directors was held and that former vice chairman of LG H&H, another non-executive director Seok-yong Cha was appointed as Hugel's new chairman and chairman of the board of directors. Chairman Cha Seok-yong served as the CEO of LG Household & Health Care for 18 years from 2005 to 2022. He set records for 17 consecutive years of sales and operating profit growth. In particular, through a total of 28 significant mergers and acquisitions (M&A), it strengthened the portfolio of each business division and expanded the market to North America, China, and Japan, and grew LG Household & Health Care into a global company as well as the number one in the domestic beauty industry. Chairman Cha also served as president of P&G Korea and CEO of Haitai Confectionery. With the recruitment of Chairman Cha Seok-yong, Hugel is expected to gain strength in leaping into the global top tier. Based on Chairman Cha's know-how in the aesthetic field and experience in pioneering overseas markets, the company plans to advance further its global strategy for botulinum toxin, fillers, and cosmetics, and accelerate growth by strengthening new business development activities. Brent L. Saunders, who previously served as Chairman of Hugel's Board of Directors, will serve as Chairman of the newly created Advisory Board. An official from Hugel expected, "The new chairman Cha Seok-yong will lead Hugel's global growth with the support of shareholders along with the existing board of directors based on business insights that cross various industries as well as aesthetics."
- Company
- AstraZeneca appoints Suyeon Kim as head of AZ Singapore
- by Eo, Yun-Ho Apr 03, 2023 05:49am
- AstraZeneca has appointed Suyeon Kim (49) from AstraZeneca Korea as General Manager of AstraZeneca Singapore. Suyeon Kim, who has been serving as the Head of the International Oncology Franchise at AstraZeneca, officially took office as General Manager on the 27th of last month. After entering Pfizer Korea as a marketing representative 20 years ago, Kim built her marketing career serving various posts at various multinational pharmaceutical companies, including at Novartis Korea's Oncology Business Unit. After joining AstraZeneca in 2016, Kim served as the Business Unit Director of Oncology and drove the growth of the company’s targeted anticancer therapy ‘Tagrisso,’ and has been serving as the International Oncology Brand Director of Lung Cancer since 2020. With the appointment, AstraZeneca placed Koreans as heads in three of its Asian subsidiaries. In addition to Suyeon Kim, the Korean subsidiary of AstraZeneca Korea is being led by Sang-Pyo Kim (53) since 2018, and the Indonesian subsidiary is being led by Sewhan Chon (49) since 2020.
- Company
- 4 out of 5 biopharmaceuticals increased exports
- by Kim, Jin-Gu Apr 03, 2023 05:49am
- Annual exports of individual pharmaceutical bio companies exceeded 2 trillion won. Last year, Samsung BioLogics recorded exports of 2.8 trillion won, up 2.3 times from the previous year, and Celltrion is also on the verge of achieving 2 trillion won. Of the 30 major listed biopharmaceutical companies, 24 showed an increase in export performance compared to the previous year. In addition to Samsung Biologics and Celltrion, ST Pharm, Ildong Pharm, Handok, HK Inno.N, and Daewoong are on the rise. According to the Financial Supervisory Service on the 3rd, the export performance of 30 major listed pharmaceutical companies in Korea last year was 7.3188 trillion won. Compared to 5.1946 trillion won in 2020, it increased by 37.4%. Exports of domestic biopharmaceutical companies increased significantly in the course of the prolonged COVID-19 crisis. In 2020, the first year of Corona, the exports of 30 companies were 3,989.8 billion won 2020, exceeding 5 trillion won the following year and 7 trillion won last year, respectively. The increase in the export performance of Samsung Biologics is remarkable. Samsung BioLogics' annual exports increased from 494.5 billion won in 2019 to 868.2 billion won in 2020 and 1.22 trillion won in 2021. Last year, the scale of exports reached 2.2 trillion 846.6 billion won, and the rate of increase was even steeper. It is an analysis that the company's exports have also increased significantly as the corona vaccine, which was consigned in earnest in 2021, was exported last year. In addition to the corona vaccine, export performance has increased significantly as the volume of biopharmaceutical CDMO has steadily increased. It is analyzed that the incorporation of Samsung Bioepis into a 100% subsidiary also contributed significantly to the expansion of export performance. The increase in Samsung Biologics' exports directly contributed to the company's record-high sales. Samsung BioLogics recorded sales of 3.13 trillion won last year, 94.8% of which came from exports. Sales of Samsung Biologics were 2.8 trillion won and sales of Celltrion were 2 trillion won, last year’s record-breaking export performance. By region, exports to Europe increased by 137% from 753.8 billion won to 1.7859 trillion won, and exports to North America increased by 90% from 448.6 billion won to 854 billion won. Exports to other regions other than North America and Europe also stood at 19.3 billion won in 2020, but increased more than 10 times to 206.7 billion won last year. Celltrion Healthcare also set a record high with exports of just under 2 trillion won. Celltrion exports biosimilars around the world through its affiliate Celltrion Healthcare. The company's exports last year were 1,964.7 billion won, up 9.0% from 1,802.9 billion won in 2021. ◆ Last year, 4 out of 5 listed pharmaceutical companies increased their export performance Of the 30 companies surveyed, 24 companies, excluding 6, increased their exports 4 out of 5 pharmaceutical companies saw their export performance improve. In particular, Samsung Biologics, Ildong Pharmaceutical, Handok, HK Inno.N, and Daewoong Pharmaceutical showed an increase of more than 50% compared to the previous year. One company that might be of interest is ST Pharm. ST Pharm's exports last year were 218.4 billion won, up 68.3% from 129.8 billion won in 2021. Among the 30 companies surveyed, exports are the sixth highest. Only Samsung Biologics, Celltrion, GC Pharma, SK Biopharm, and SK Bioscience recorded higher exports than ST Pharm. ST Pharm's export performance has been steadily increasing since 2019. The company's exports, which stood at 46 billion won in 2019, increased by 1.6 to 1.7 times each year over the past four years, to 79.6 billion won in 2020, 129.8 billion won in 2021, and 218.4 billion won last year. It is an analysis that the oligonucleotide drug substance business, which the company has taken as a new growth engine, is cruising. The share of new drug APIs in the company's exports is increasing year by year. In 2019, exports of new drug APIs were 24.7 billion won, accounting for only 53.7% of total exports. Last year, exports of new drug APIs reached 172.2 billion won, a nearly seven-fold increase in three years. The share of total exports also increased by 25.1%p over the past three years to 78.8%.
- Company
- Bladder cancer drugs/new mechanisms appear one after another
- by Eo, Yun-Ho Mar 31, 2023 06:09am
- New treatment options for urothelial cancer are emerging one after another. Domestic commercialization of new drugs such as targeted anticancer drugs and antibody-drug conjugates (ADCs) is underway. Janssen's Balversa, which was approved at the end of last year, is suitable for patients with metastatic urinary tract disease with FGFR2 or 3 mutations who have progressed despite treatment with at least one chemotherapy agent or who have progressed within 12 months of adjuvant therapy before and after surgery including platinum-based chemotherapy. It can be prescribed for patients with epithelial cancer (bladder cancer). Bladder cancer is representative cancer for which there is no targeted anticancer drug. Balversa has become the first targeted anti-cancer drug for bladder cancer with a new mechanism of FGFR (fibroblast growth factor receptor) inhibition. FGFR is one of the biosignals involved in cancer cell growth and is associated with several carcinomas. In particular, FGFR mutations are commonly observed in bladder cancer, and about 20 to 30% of patients are known to have mutations. Phase 2 BLC2001, which served as the basis for Balversa's approval, targeted 99 patients with locally advanced metastatic urothelial cancer with FGFR mutations. The objective response rate of 87 evaluable patients was 32.2% based on the IRRC evaluation standard. The disease control rate was 78%, and the median duration of response was 5.4 months. mPFS and mOS were 5.5 months and 13.8 months, respectively. Astellas Pharmaceuticals' ADC drug 'Padcep (Enfotumabvedotin)' obtained domestic approval on the 10th. This drug can be prescribed for adult patients with locally advanced or metastatic urothelial cancer who have ▲PD-1 or PD-L1 inhibitors, ▲and platinum-based chemotherapy. Padcev, which targets the Nectin-4 protein, which is frequently observed on the surface of urothelial cancer cells, binds to Nectin-4 expressed on the cell surface and moves into the cell, inhibiting cell division within the cell. MMAE is released to induce apoptosis of cancer cells. Padcev's approval was a global phase 3 clinical study comparing Padcev with conventional chemotherapy in 608 patients with locally advanced or metastatic urothelial cancer who had prior experience with platinum-based chemotherapy and PD-1/L1 inhibitor treatment. This was done based on the results of EV-301. As a result of the study, the Padcev-administered group reduced the risk of death by about 30% compared to conventional chemotherapy, and the mOS of the Padcev-administered group was 12.9 months, demonstrating a significant improvement in survival time compared to 9.0 months of chemotherapy. Padcev's mPFS was 5.6 months versus 3.7 months for the control group, reducing the risk of disease progression by 38%.
- Company
- Generic for Godex development has come to an all-stop
- by Nho, Byung Chul Mar 31, 2023 06:09am
- As pharmaceutical companies preparing to release generics for Godex announced that they would give up development, Celltrion Pharm is expected to dominate. According to the industry, about three pharmaceutical companies have been identified that are preparing generics for Godex, but drug development has been suspended due to development difficulties/declining product margins. Reasons for stopping the release of generics can be roughly divided into difficulties in 'registering DMF' and 'securing bioequivalence', as well as rising costs following continued drug price cuts. In the meantime, the price of Godex is currently listed at 312 won after going through ten price cuts from 422 won at the time of permission in 2009. When a generic is released, the drug price will drop to W166, which could significantly lower margins to 144 won, the price of Nissel for a single Pharmaking BDD. Godex contains Biphenyl Dimethyl Dicarboxylate/BDD 25mg as the main ingredient, Carnitine Orotate 150mg, Adenine Hydrochloride 2.5mg, Antitoxic Liver Ext. 12.5mg, Cyanocobalamin 125μg, Pyridoxine Hydrochloride 25mg, and Riboflavin. In addition, it is observed that the biggest obstacle is the certification and confirmation of the drug substance registration (DMF) of Antitoxic Liver Ext., one of Godex. Except for some injections, DMF registration has been made mandatory for drug substances used in all medicines since 2017. In the case of Antitoxic Liver Ext., which is extracted from cow liver, DMF is not registered, so generic companies have to bear the burden of proving it by investing a huge amount of money. According to what is known, Celltrion Pharmaceuticals, the original developer, also has different laws and regulations at the time of product development and approval. If the lineup is expanded to tablets (pills) following existing capsules, DMF registration is required, making it difficult to launch new products with the same ingredients. the situation that might be possible. Meanwhile, BDD, the main component of Godex, is known to have been first developed by China's LIU in 1982. There is Pharmaking Nissel for BDD single drug and Pharmaking Pennel for a combination. The first company to launch a BDD single ingredient in Korea was Taerim Pharmaceutical, which changed its name to Pharmaking in 2005. Godex, which obtained permission in January 2000, is a blockbuster drug with 70 billion prescriptions as a 7-drug complex with 25mg of BDD as the main ingredient, the same as Nissel Pennel. BDD, the main component of Godex·Nissel·Pennel, rapidly lowers GPT, the level of liver inflammation, through antioxidant action, normalizes ALT level, and reduces the rebound phenomenon in which ALT rises again when medication is discontinued.
