-
Sino Biopharmaceutical Ltd Receives NMPA Approval for KRAS G12C Inhibitor Garsorasib
•
Sino Biopharmaceutical Ltd (HKG: 1177), a leading biopharmaceutical company in China, has announced that it has received conditional marketing approval from the National Medical Products Administration (NMPA) for garsorasib (D-1553), a KRAS G12C inhibitor co-developed with InventisBio (Shanghai) Co., Ltd. The drug is indicated for the treatment of patients with…
-
Daiichi Sankyo and Alteogen Sign $300 Million Deal to Develop Subcutaneous Enhertu
•
Daiichi Sankyo (TYO: 4568), a leading Japanese pharmaceutical company, has entered into a potentially $300 million agreement with South Korean biotechnology firm Alteogen to develop a subcutaneous injection version of its cancer drug Enhertu, which is also in collaboration with AstraZeneca. This innovative step aims to enhance patient accessibility and…
-
Dizal Pharmaceutical Submits NDA to FDA for Sunvozertinib as NSCLC Therapy
•
Dizal Pharmaceutical Co., Ltd (SHA: 688192), a Chinese pharmaceutical company, has announced the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for sunvozertinib, a targeted therapy for lung cancer. The company is seeking approval for the treatment of locally advanced or metastatic non-small…
-
MGI Tech Co., Ltd Partners with Human Cell Atlas Consortium to Advance Cell Mapping
•
China-based gene sequencing specialist, MGI Tech Co., Ltd, (SHA: 688114) has announced a commercial collaboration with the Human Cell Atlas (HCA) consortium, marking a significant step forward in the human cell mapping initiative. This partnership aims to expand access to MGI’s proprietary products within the HCA network by offering discounted…
-
AstraZeneca Confirms Executive Vice President Leon Wang’s Detention in China
•
AstraZeneca Inc., (AZ, NASDAQ: AZN), a leading UK pharmaceutical company, has provided an update to investors regarding the status of Leon Wang, Executive Vice President International and AstraZeneca China President. The company has confirmed that Wang is currently “in detention” in China and was last reported to be “cooperating with…
-
Jiangsu Kanion Pharmaceutical to Acquire Xintrum Pharmaceuticals for RMB 270 Million
•
Jiangsu Kanion Pharmaceutical Co., Ltd (SHA: 600557), a China-based pharmaceutical company, has announced its intention to acquire 100% stakes in Xintrum Pharmaceuticals, Ltd, a biologic drug developer, for a consideration of RMB 270 million (USD 37.7 million). Upon completion of the deal, Xintrum will become a wholly owned subsidiary of…
-
Ascletis Pharma’s ASC47 Showcases Promising Weight Loss Results in Phase I Clinical Trial
•
Ascletis Pharma Inc. (HKG: 1672), a China-based pharmaceutical company, has announced positive results from a Phase I clinical study for its drug candidate ASC47 in Australia. This in-house developed therapy is designed to facilitate weight loss without the loss of muscle mass, offering a potential new option for obesity management.…
-
Nuwacell Biotechnologies Secures RMB150 Million in Series B Financing for iPSC Therapies
•
Nuwacell Biotechnologies Co., Ltd., a specialist in induced pluripotent stem cell (iPSC) technology based in Heifei, Anhui province, has reportedly secured RMB150 million (USD21 million) in the first closing of its Series B financing round. The funding was led by Guangzhou Industry Investment, with significant contributions from China Resources International,…
-
Shanghai Henlius Biotech Partners with SVAX to Boost MENAT Region’s Access to Biological Drugs
•
Shanghai Henlius Biotech Inc. (HKG: 2696), a leading Chinese biotech company, has entered into a strategic partnership with AL-TIRYAQ AL-KHALAWI Medical Company (SVAX), a healthcare unit owned by the prominent Fakeeh family in Saudi Arabia, during the 2024 China International Import Expo (CIIE). This collaboration aims to leverage Henlius Bio’s…
-
Johnson & Johnson MedTech’s Varipulse Platform Receives FDA Approval for Atrial Fibrillation Treatment
•
Johnson & Johnson MedTech (J&J, NYSE: JNJ) has announced that it has received marketing approval from the US Food and Drug Administration (FDA) for its Varipulse platform, marking a significant advancement in the treatment of drug refractory paroxysmal atrial fibrillation (AFib). The Varipulse platform is the company’s first pulsed field…
-
Sichuan Biokin Pharmaceutical Gets FDA Approval for Phase I Study of BL-M17D1 in Solid Tumors
•
Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a China-based pharmaceutical company, has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase I clinical study for its in-house developed bispecific antibody drug conjugate (ADC), BL-M17D1, in patients with advanced solid tumors. BL-M17D1’s…
-
Bayer AG Receives FDA 510(k) Clearance for MEDRAD Centargo CT Injection System
•
Germany-based Bayer AG (ETR: BAYN) has announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its MEDRAD Centargo CT Injection System. This innovative multi-patient injector is designed to enhance workflow efficiency and integrates seamlessly with Bayer’s existing portfolio of products, particularly in high-volume…
-
Sichuan Huiyu Pharmaceutical’s HYP-6589 Receives NMPA Approval for Solid Tumor Clinical Trial
•
Sichuan Huiyu Pharmaceutical Co., Ltd (SHA: 688553), a China-based pharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 chemical drug, HYP-6589, which targets advanced solid tumors. HYP-6589’s Mechanism of ActionHYP-6589 is an in-house developed SOS1 small molecule…
-
Ascentage Pharma’s Lisaftoclax and AceLink Therapeutics’ AL01211 Receive FDA Designations
•
The Center for Drug Evaluation (CDE) website has indicated that China-based Ascentage Pharma’s (HKG: 6855) lisaftoclax (APG-2575) and AceLink Therapeutics(Suzhou)’s AL01211 are on track to receive priority review and breakthrough therapy designation (BTD) statuses respectively from the US Food and Drug Administration (FDA). Lisaftoclax, an oral BCL-2 inhibitor, is indicated…
-
AskBio’s AB-1003 Receives Rare Pediatric Disease and Orphan Drug Designations from FDA
•
Asklepios BioPharmaceutical, Inc. (AskBio), a wholly owned subsidiary of Bayer AG (ETR: BAYN), has announced that it has received both rare pediatric disease designation (RPDD) and orphan-drug designation (ODD) from the US Food and Drug Administration (FDA) for its investigational gene therapy, AB-1003 (LION-101). The therapy targets limb-girdle muscular dystrophy…
-
Teva Pharmaceutical Expands Partnerships in China’s One Health Sector with New Agreements
•
Israel based Teva Pharmaceutical Industries Ltd (NYSE: TEVA) has announced new partnerships with Chinese firms Zhejiang International Group Co., Ltd. and Jianmin International Co., Ltd. These collaborations aim to enhance Teva’s commercial layout in the “One Health” sector, increasing the availability of quality products for Chinese consumers. Strategic Agreements at…
-
Bayer’s Leap Forward: Implementing Salesforce on Alibaba Cloud for Customer Engagement
•
Bayer (ETR: BAYN) has announced that its China Prescription Medicines business has fully adopted the “Salesforce on Alibaba Cloud” solution, creating an all-new customer interaction platform, OPERA 2.0, for thousands of internal Bayer users. Bayer is one of the first multinational pharmaceutical companies in China to implement a new customer…
-
CDE Releases Technical Guidelines for Pilot Registration and Phased Manufacturing of ADCs
•
The Center for Drug Evaluation (CDE) has issued the “Technical Requirements for Pilot Registration and Application of Phased Manufacturing of Antibody Drug Conjugates (ADC).” This document complements the “Pilot Work Plan for Phased Manufacturing of Biological Products” released last month and aims to guide the pilot work of phased manufacturing…
-
Shanghai Pharmaceuticals’ MediTrust Health Partners with Eisai for Comprehensive Patient Services
•
Shanghai Pharmaceuticals Holding Co., Ltd’s (HKG: 2607, SHA: 601607) subsidiary, MediTrust Health, which specializes in insurance, financing, and direct-to-patient pharmacy services, has entered into a strategic partnership with Japanese pharmaceutical company Eisai (TYO: 4523). This collaboration grants Eisai access to MediTrust Health’s “One-Code Direct Payment-Diversified Payment Platform,” aiming to establish…
-
Boehringer Ingelheim Partners with Wuhan Union Hospital to Enhance Clinical Research and Development
•
Boehringer Ingelheim, a leading German pharmaceutical company, has entered into a strategic partnership with Wuhan Union Hospital, marking a significant step in the realm of clinical research. This collaboration will extend beyond clinical studies to include academic exchanges, patient education, and talent development, among other areas, in alignment with Boehringer…
