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PharmaVibeWeekly pharma news review from November 21 to 25, covering information from drug review and approval, R&D, to businessThis week, in terms of drug review and approval, Class 1 new drug for lung cancers from Chase Sun Pharmaceutical was finally approved in China, taking nearly five years. In abroad, etranacogene dezaparvovec was approved by FDA for marketing, being the first gene therapy approved for the treatment of Hemophilia B. In terms of R&D, a number of clinical trials yielded positive results, with MSD PD-1 monoclonal antibody K drug in combination with chemotherapy for the treatment of GEJ adenocarcinoma reaching its Phase III primary endpoint. In terms of business, there were few major events, but MSD's acquisition of...2022-11-2914 minPharmaVibeThe First Domestically Developed JAK Inhibitor Ivarmacitinib is Expected to Be First Marketed in China for Autoimmune System DiseasesThis week, BeiGene's new indication for Zanubrutinib was approved in the EU while TopAlliance submitted a marketing application for the anti-PD-1 monoclonal antibody Toripalimab in the EU. The most noteworthy in the R&D section is Hengrui's JAK inhibitor Phase III clinical success, making it be expected to become the first product made in China in the field of autoimmune system diseases. In the area of business, Hansoh Pharmaceutical Group introduced EGFR/cMet bispecific antibodies, which are expected to link up with Almonertinib in a deal valued at up to RMB1.468 billion. More pharma news of this week worthy...2022-11-2215 minPharmaVibeNMPA Nod Gives YL-Pharma First Highly Selective PI3Kδ Inhibitor Marketing Approval in ChinaThis week, the first highly selective PI3Kδ inhibitor in China, linperlisib of YL-Pharma, was approved for marketing. Multiple positive results have been released from several clinical trials, but GSK announced that the Phase III superiority trial of its BCMA ADC combined with pomalidomide in the treatment of relapsed or refractory multiple myeloma, did not meet its primary endpoint of progression-free survival (PFS). Jumpcan Pharmaceutical entered into a cooperation agreement with Newsoara and obtained the development rights of two innovative drugs. More pharma news of this week worthy of attention covers topics on drug review, R&D, and business. Y...2022-11-1514 minPharmaVibeThe Marketing Approval of Luye Pharma’s First-in-class Anti-depressant Drug in ChinaThis week, Toludesvenlafaxine Hydrochloride Extended-Release Tablets, a kind of first-in-class anti-depressant drug developed by the Chinese company Luye Pharma, was approved for marketing. In terms of R&D, the phase III clinical research of PCSK9 Monoclonal Antibody developed by Akeso met the endpoints and was planned to apply for marketing. In terms of business, SonnetBio and Janssen, a subsidiary of Johnson & Johnson, reached a cooperation agreement on three candidate products. More pharma news of this week worthy of attention covers topics on drug review, R&D, and business. You can get more industry insights and firsthand market information from Ch...2022-11-0814 minPharmaVibeThe Marketing Declaration of HAISCO’s Novel Analgesic for Diabetic Peripheral Neuralgia TreatmentThis week, the marketing application of HAISCO's first-in-class HSK16149 Capsule was submitted, presumably for the treatment of diabetic peripheral neuralgia. Several clinical trials achieved positive results, while Alpine Immune terminated two clinical trials of davoceticept due to the death of patients. More pharma news of this week worthy of attention covers topics on drug review, R&D, and Listing. You can get more industry insights and firsthand market information from China to the globe at PharmaSources.com
Online registration for CPHI & PMEC China Virtual Expo Connect is in full swing. Over the past three weeks, mo...2022-11-0113 minPharmaVibeThe Marketing Approval for GSK’s Two-Drug HIV Treatment in ChinaThis week, the two most noteworthy news were the approval of the two-drug HIV therapy developed by GSK for marketing in China and the submission of the marketing application for Zevorcabtagene Autoleucel injection of CARsgen, which is the second BCMA CAR-T product to be declared for marketing in China. The results of the Phase I study of Innovent’s GLP-1R/GCGR dual agonist were published, with a weight loss of over 11.5% at 12 weeks of dosing. More pharma news of this week worthy of attention covers topics on drug review, R&D, and Listing. You can get more industry in...2022-10-2512 minPharmaVibeChina’s NMPA Nod Gives Hua Medicine First GKA Approval in DiabetesThis week, Hua Medicine received marketing approval from China's NMPA for its glucokinase activator Dorzagliatin Tablets to treat type II diabetes It makes the first glucokinase activator drug to gain approval in any market. While in the global market, BeiGene announced that zanubrutinib achieved superior Progression-Free Survival (PFS) versus ibrutinib in a final analysis of the Phase 3 ALPINE trial, as assessed by an independent review committee and investigator. More pharma news of this week worthy of attention covers topics on drug review, R&D, and business. You can get more industry insights and firsthand market information from China to...2022-10-1814 minPharmaVibeThe Marketing Declaration of The First JAK inhibitor made in ChinaThis week, in the Chinese pharma market, Humanwell Healthcare's first generic drug of oxycodone hydrochloride sustained release tablets were approved for marketing; Zelgen Biopharmaceuticals' Jaktinib, the first JAK inhibitor made in China, was declared for marketing, and LEGN.US' Cilta-cel, a BCMA CAR-T cell therapy, was approved in Japan. In terms of R&D, Eisai and Biogen announced positive results from the Phase III trial of Lecanemab to treat Alzheimer's disease (AD). More pharma news of this week worthy of attention covers topics on drug review, R&D, business, and policy. You can get more industry insights and firsthand m...2022-10-0814 minPharmaVibeInnoCare Completes IPO on the STAR Market of the Shanghai Stock Exchange in ChinaThis week, in China, Nanjing Biosnwill Pharma's Class 2.2 new drug Edaravone Sublingual Tablets and Yichang Humanwell's Class 3 generic drug Clobazam Tablets have been approved by the NMPA for marketing. Meanwhile, new indications have been approved for both Junshi Biosciences' Toripalimab and AstraZeneca's Olaparib Tablets; New progress with the EMA and FDA approvals has been achieved for some popular drugs. For example, Roche's bispecific antibody ophthalmic drug Faricimab has been approved for marketing in the EU. Although there has been nothing new in R&D during the week, on the business side, Chiatai Tianqing entered into a collaboration agreement with...2022-09-2714 minPharmaVibeThe First FDA-Approved Therapy to Improve Renal Function of Adult HRS PatientsThis week, in China, Humanwell Healthcare's Class 1.2 traditional Chinese medicine was approved for marketing. Pearl Bio's Bozitinib enteric capsule was planned to be included for priority approval. Several new drugs were approved for clinical trial stages, or the applications for such trials were submitted. While globally, the terlipressin injection became the world's first FDA-approved therapy to improve renal function in adult patients with hepatorenal syndrome (HRS). Besides, several drugs have obtained Fast Track Designation (FTD), and many innovative drugs achieved positive clinical results, despite the fact that there were also a few drug failures.
Other pharma news...2022-09-2015 minPharmaVibeThe marketing declaration of Eli Lilly’s hypoglycemic drug tirzepatide in ChinaThis week, the most noteworthy event is Eli Lilly's hypoglycemic drug tirzepatide, a GIP/GLP-1 double agonist, was declared for marketing in China. In the meanwhile, there comes some good news for clinical trial applications of various important drugs. On the R&D side, the pivotal Phase III clinical trials of several drugs have shown positive results, which are related to thyroid carcinoma, pulmonary interstitial fibrosis, migraine, plaque psoriasis, and other indications. Other pharma news collected this week features 25 pieces of information covering topics on drug review, R&D, and business. You can get more industry insights and firsthand...2022-09-1415 minPharmaVibeThe First and Only TIGIT/TGFβ Bispecific Antibody Under Research in the WorldThe marketing approval of SinoCellTech's new anti-CD20 monoclonal antibody ripertamab aroused the attention of the industry in China this week. While the clinical trial application of the AK130 injection developed by another Chinese company Akeso was accepted, making it the first and the only TIGIT/TGFβ bispecific antibody under research in the world. Other pharma news collected this week features 26 pieces of information covering topics on drug review, R&D, business, and listing. You can get more industry insights and firsthand market information from China to the globe at PharmaSources.com
2022-09-0716 minPharmaVibeEU issues GMP Annex 1 final revision for sterile drug productsIn the last week's Chinese pharma market, the 11th indication of BeiGene’s PD-1 Tislelizumab was declared for marketing for the treatment of esophageal squamous cell carcinoma. While in the global pharma market, Johnson & Johnson’s Teclistamab was approved by the EC, making it the first BCMA/CD3 bispecific antibody approved for marketing worldwide. In addition, the EU officially released the eagerly anticipated final revision of its GMP Annex 1 for sterile drug products. Other pharma news collected in this episode covers 4 sections including drug review, R&D, business, and policy. You can get more industry insights and firsthand market info...2022-08-3012 minPharmaVibeThe first Chinese bispecific antibodies ADC declared for clinical useHey! This is Weekly Pharma News Review from PharmaVibe. I'm Billy. It's been a long time since our last episode. I hope all of you' re doing well and thank you for joining us today. In the last week's Chinese pharma market, Alphamab Oncology’s JSKN003 injection became the first Chinese bispecific antibody ADC declared for clinical use. While in the global pharma market, AstraZeneca/Daiichi Sankyo, Novartis and Sanofi all provide update on their clinical development programs. You can access the full version on Access the full transcript and more fresh content at www.pharmasources.com and enjoy more f...2022-08-2412 minPharmaVibeWeekly Pharma News Review (0523-0529)CPhI & P-MEC China officially announced the opening ceremony time of the online exhibition - the main event will be grandly unveiled on June 21. From June 22 to 30, the organizer will launch a series of multilingual themed forums to conduct in-depth discussions on R&D, cold chain transportation, environmental management, injection packaging, and intelligent and continuous manufacturing.
While a steady flow of good news kept pouring into the Chinese pharmaceutical market last week. FDA approved Hengrui’s ANDA for Iodixanol Injection while its SHR3680 tablets in treating prostate cancer had conducted Phase III clinical trial successfully. As the icing on...2022-06-0111 minPharmaVibeWeekly Pharma News Review (0516-0522)The CPhI & P-MEC China's Virtual Expo Connect announced its extension last week. The online event will continue until June 30. The first therapeutic effect data release of Junshi Biosciences and Vigonvita's VV116, a small-molecule oral drug for COVID-19, captivated the industry. According to the study, VV116 showed signs of improved performance and effectiveness in treating patients with non-severe Omicron infection. Access the full transcript and more fresh content at www.pharmasources.com.
2022-05-2510 minPharmaVibeWeekly Pharma News Review (0506-0514)As the CPhI & P-MEC China VEC event comes to its fourth week, a wave of online Hosted Buyer Video Meeting registrations appears. The Chinese company Hengrui Medicine said a global phase III trial of its PD-1 inhibitor camrelizumab and VEGFR inhibitor apatinib, has hit its goals in newly diagnosed patients with liver cancer. The company plans to start a conversation soon with FDA for a potential new drug application. Access the full transcript and more fresh content at www.pharmasources.com.
2022-05-1810 minPharmaVibeWeekly Pharma News Review (0424-0501)AstraZeneca and Daiichi Sankyo's Enhertu has been granted Breakthrough Therapy Designation for patients with HER2-low metastatic breast cancer in the US. While in China, its marketing application for the treatment of patients with HER2-positive unresectable or metastatic breast cancer treated with one or more prior anti-HER2-based regimens was proposed to be included in the updated publicity list of priority reviews. Access the full transcript and more fresh content at www.pharmasources.com.
2022-05-0311 minPharmaVibeWeekly Pharma News Review (0418-0424)The Virtual Expo Connect event of CPhI & P-MEC China was fully launched on April 21. While in the last week’s Chinese pharma market, Ascletis said that in antiviral cellular assays, the antiviral potency of ASC11 was 31-fold of that of Nirmatrelvir, a compound found in Pfizer's Paxlovid. The data suggested that its drug ASC11 showed the potential to be an effective treatment for COVID-19. Access the full transcript and more fresh contents at www.pharmasources.com
2022-04-2711 minPharmaVibeWeekly Pharma News Review (0411-0417)The sharp crushing in the stock prices of Chinese vaccine companies Zhifei Biological and Wantai Biological is the most-watched news of this week. It arises from the WHO press release on the solid protection of a single-dose HPV vaccination against cervical cancer. The digital extension of CPhI&P-MEC China "Virtual Expo Connect" is back. Access the full transcript at www.pharmasources.com
2022-04-2013 minPharmaVibeWeekly Pharma News Review (0331-0408)The release of phase III clinical data for treating outpatients infected with mild and moderate COVID-19 with Kintor Pharmaceuticals' proxalutamide sparked an intense interest this week. Subscribe PharmaVibe on pharmasources.com for the pharma news we collected to get firsthand market information in the Chinese and global markets: https://www.pharmasources.com
2022-04-1310 minPharmaVibeWeekly Pharma News Review (0328-0401)Phase III clinical trials' failure targeting the popular target TIGIT monoclonal antibody has once again put tumor immunotherapy on the radar this week. Subscribe PharmaVibe on pharmasources.com for the pharma news we collected this week covering drug review, R&D, business, and listing sections to get firsthand market information: http://www.pharmasources.com
2022-04-0711 minPharmaVibeWeekly Pharma News Review (0321-0325)This week we collected 18 pieces of news in drug review, R&D, and business. It is comforting to know that two drugs for the treatment of neuroblastoma from PersonGen and Ascentage Pharma have received the qualification of orphan drugs, which my reduce the risk of this severe disease after they were granted market approval.
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2022-03-3008 minPharmaVibeWeekly Pharma News Review (0314-0318)The pharma news review of this week will go through 24 pieces of news in 3 sections, drug review, R&D, and business.
One of the most exciting news of this week was the marketing approval of duvelisib capsules. This is a dual PI3K inhibitor introduced by CSPC Pharmaceutical Group Co., Ltd.
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2022-03-2412 minPharmaVibeWeekly Pharma News Review (0307-0312)We've been in this pandemic for two years. Luckily, the therapeutic drug, as well as the self-testing products, give people a boost of confidence.
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2022-03-1611 minPharmaVibeWeekly Pharma News Review (0228-0304)The news reviewed in this episode is from February 28 to March 4, covering 19 pieces of information in Review, R&D, and Transaction. The most talked-about news of this week is the successful overseas marketing of Nanjing Legend Biotech's CAR-T, cilta-cel.
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2022-03-0909 min