•
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 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 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 (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 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…
•
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 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…
•
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…
•
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…
•
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 (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…
•
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 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, 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…
•
Hainan Haiyao Co., Ltd (SHE: 000566), a prominent Chinese company, has announced the signing of an initial joint venture (JV) agreement with the Haikou National High-tech Industrial Development Zone Management Committee and Xenios AG, a subsidiary of German healthcare giant Fresenius Medical Care AG. This strategic collaboration is aimed at…
•
Belief BioMed has announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) and Pediatric Rare Disease Designation (RPDD) for its gene therapy drug, BBM-D101 injection, indicated for the treatment of Duchenne muscular dystrophy (DMD). BBM-D101: A Pioneering rAAV Gene Therapy for Duchenne Muscular DystrophyBBM-D101…
•
China-based Nanjing Leads Biolabs Co., Ltd and venture capital firm Aditum Bio have announced the establishment of Oblenio Bio, along with an exclusive option and license agreement to develop LBL-051, a first-in-class CD19xBCMAxCD3 tri-specific T-cell engager antibody targeting autoimmune diseases. Aditum Bio will provide funding for Oblenio Bio, and together…
•
French pharmaceutical giant Sanofi (NASDAQ: SNY) has signed a partnership deal with Cathay Capital, a global private equity and venture capital investment firm, at the 7th China International Import Expo (CIIE). This collaboration aims to deepen their existing long-term cooperation and serves as a positive step towards promoting Sino-French cooperation…
•
At the 7th China International Import Expo (CIIE), Japan-based Eisai Co., Ltd (TYO: 4523) entered into a Memorandum of Understanding (MoU) with US medical device and life sciences giant GE Healthcare Technologies Inc. (NASDAQ: GEHC). The partnership, centered on the early detection, precise diagnosis, and treatment of Alzheimer’s disease (AD),…
•
Lohmann & Rauscher, a medical group with headquarters in Germany and Austria, has entered into a partnership with China-based Allmed Medical Products Co., Ltd. (SHE: 002950) at the 7th China International Import Expo (CIIE). The collaboration aims to leverage the complementary strengths of both companies to provide a more diversified…