The First Domestically Developed JAK Inhibitor Ivarmacitinib is Expected to Be First Marketed in China for Autoimmune System Diseases
The online platform for CPHI & PMEC China is fully live now! The online event will be live for 54 days to help you connect for an extended period of time. Looking back on this week’s pharma news, 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.
15 Nov 2022
NMPA Nod Gives YL-Pharma First Highly Selective PI3Kδ Inhibitor Marketing Approval in China
This 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.
8 Nov 2022
The Marketing Approval of Luye Pharma’s First-in-class Anti-depressant Drug in China
This 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.
1 Nov 2022
The Marketing Declaration of HAISCO’s Novel Analgesic for Diabetic Peripheral Neuralgia Treatment
This 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.
25 Oct 2022
The Marketing Approval for GSK’s Two-Drug HIV Treatment in China
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.
18 Oct 2022
China’s NMPA Nod Gives Hua Medicine First GKA Approval in Diabetes
The news review of this week is from October 8 to 14, covering a total of 25 pieces of information in 3 sections, i.e. drug review and approval, R&D, and business.
8 Oct 2022
The Marketing Declaration of The First JAK inhibitor made in China
This week, in terms of drug review and approval, three pieces of news are particularly worthy of attention: 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); There is also some news worthy of attention in terms of business and policy.
27 Sept 2022
InnoCare Completes IPO on the STAR Market of the Shanghai Stock Exchange in China
This 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 Inventiva for the development of lanifibranor, a pan-PPAR agonist. Besides, InnoCare Pharma was successfully listed on the STAR. Other pharma news collected this week features 25 pieces of information covering topics on drug review, R&D, business and listing.
20 Sept 2022
The First FDA-Approved Therapy to Improve Renal Function of Adult HRS Patients
This 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. While globally, the terlipressin injection became the world’s first FDA-approved therapy to improve renal function in adult patients with hepatorenal syndrome (HRS). Other pharma news collected this week features 26 pieces of information covering topics on drug review, R&D, and business.
14 Sept 2022
The marketing declaration of Eli Lilly’s hypoglycemic drug tirzepatide in China
This 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 market information from China to the globe at PharmaSources.com
7 Sept 2022
The First and Only TIGIT/TGFβ Bispecific Antibody Under Research in the World
The 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.
30 Aug 2022
EU issues GMP Annex 1 final revision for sterile drug products
In 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.
24 Aug 2022
The first Chinese bispecific antibodies ADC declared for clinical use
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.
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