NewTimeSpace News: Innovent Biologics (01801.HK) announced that the new drug application for the combination therapy of Tyvyt® (Sintilimab Injection) and Elunate® (Fruquintinib) has been approved by the NMPA. It is indicated for locally advanced or metastatic renal cell carcinoma in patients who failed prior VEGFR-TKI treatment and have not received first-line PD-1/PD-L1 inhibitors. This marks the 10th approved indication of Tyvyt®.
NewTimeSpace News: Hbm Holdings Limited (02142.HK) announced preclinical research findings of LET003, its next-generation ACVR2A/2B-targeted monoclonal antibody developed via the Hu-mAtrIx™ AI platform. Data revealed that combination therapy of LET003 and semaglutide delivers markedly enhanced fat reduction and effective lean mass preservation. The combined group achieved a 34.7% greater reduction in fat mass and a 5.7% rise in lean mass compared with semaglutide monotherapy.
NewTimeSpace News: TransThera Sciences (Nanjing), Inc. (02617.HK) announced that exploratory clinical findings of its core product tiengrtinib as monotherapy and in combination with atezolizumab for advanced solid tumors have been published in Nature Communications (Impact Factor=15.7). Clinical data show that the objective response rate (ORR) of tiengrtinib monotherapy reached 16.7%, while the combination regimen achieved an ORR of 22.6%. It demonstrated prominent efficacy in cholangiocarcinoma patients, with an ORR of 30.8% under monotherapy.
NewTimeSpace News: Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (02196.HK) announced that the drug registration application for Taohong Siwu Decoction Granules submitted by its controlling subsidiary Hebei Wanbang Fulin Pharmaceutical Co., Ltd. has been accepted by the National Medical Products Administration (NMPA). As a Class 3.1 new traditional Chinese medicine, the formulation originates from Fuke Bingjian by Qing-dynasty physician Chai Dehua and is included in the First Catalogue of Ancient Classic Prescriptions issued by the State Administration of Traditional Chinese Medicine.
NewTimeSpace News: Shanghai Henlius Biotech, Inc. (02696.HK) announced that the Phase I clinical trial of its self-developed HLX48 for injection, an EGFR/c-MET dual-target antibody-drug conjugate (ADC) for advanced/metastatic solid tumors, has been approved by the relevant Human Research Ethics Committee and completed clinical trial notification with Australia’s Therapeutic Goods Administration (TGA). No 同类 bispecific ADC has been approved globally so far.
NewTimeSpace News: Shanghai Henlius Biotech, Inc. (02696.HK) announced that its self-developed HLX97, a KAT6A/B small-molecule inhibitor, has completed first patient dosing in China for the Phase I clinical trial in patients with advanced/metastatic solid tumors. The candidate is intended for the treatment of advanced and metastatic solid tumors, and no KAT6A/B small-molecule inhibitor has been approved worldwide to date.
NewTimeSpace News: Alphamab Oncology announced on May 13 that the Phase II clinical study of JSKN033, a high-concentration subcutaneous fixed-dose combination consisting of a HER2 bispecific antibody-drug conjugate and a PD-L1 immune checkpoint inhibitor, in combination with platinum-based chemotherapy with or without bevacizumab as first-line treatment for advanced cervical cancer, has completed the first patient dosing.
NewTimeSpace News: Suzhou Riborn Biotech Co., Ltd. (06938.HK) announced that its core product vortosiran (RBD4059) has successfully submitted a Phase 2b Clinical Trial Application (CTA) to the European Medicines Agency (EMA) for the prevention and treatment of venous thromboembolism (VTE).Vortosiran is the world’s most advanced small nucleic acid drug targeting FXI. It has previously completed a Phase 2a clinical trial in Europe for coronary artery disease.
NewTimeSpace News: Sino Biopharmaceutical Limited (01177.HK) announced that its subsidiary Chia Tai Tianqing Pharmaceutical Group Co., Ltd. has entered into an exclusive strategic cooperation with GlaxoSmithKline (GSK). Chia Tai Tianqing will be responsible for the import, distribution, hospital access and promotion of bepirovirsen in Chinese Mainland.Bepirovirsen is a first-in-class antisense oligonucleotide (ASO) for the treatment of chronic hepatitis B (CHB) in adults. It has been included in both the Breakthrough Therapy Designation and Priority Review process. There are approximately 75 million hepatitis B virus-infected individuals in China.
NewTimeSpace News: Jiangsu Hengrui Pharmaceutical Co., Ltd. (01276.HK) announced that the Company and its subsidiaries have received Notices of Approval for Clinical Trials from the NMPA for five drugs, including HRS-6093 Tablets, SHR-9839 (sc) for Injection, SHR-1826 for Injection, Adebrelimab Injection, and SHR-8068 Injection. These drugs will be jointly evaluated in clinical trials for advanced malignant solid tumors with KRAS G12D mutation.Among them, HRS-6093 Tablets are a novel KRAS G12D inhibitor, with no similar products approved globally yet.
NewTimeSpace News: Jiangsu Hengrui Pharmaceutical Co., Ltd. (01276.HK) announced that it has received the Notice of Approval for Clinical Trials for HRS-3005 Tablets issued by the NMPA, approving clinical trials of the product for B-cell malignancies. HRS-3005 Tablets are an innovative anti-tumor drug independently developed by the Company. No similar drugs have been approved for marketing globally to date, with accumulated R&D investment of approximately RMB 26.2 million.
NewTimeSpace News: SSY Group Limited (02005.HK) announced that the Group has obtained drug production registration approvals from the National Medical Products Administration (NMPA) for three products. Among them, Fat-Soluble Vitamin Injection (Ⅰ) (10ml) is the first approved domestic enterprise, deemed to have passed the consistency evaluation, for intravenous nutritional supplementation in children and infants. Metformin Hydrochloride Tablets (0.5g and 0.25g) are used for the treatment of type 2 diabetes mellitus. Doxazosin Mesylate Extended-Release Tablets (4mg) are indicated for benign prostatic hyperplasia and hypertension.
NewTimeSpace News: Suzhou Raybow Biotech Co., Ltd. (06938.HK) announced that it has achieved the third key milestone in its R&D collaboration with Boehringer Ingelheim (BI) for developing innovative therapeutic solutions for liver diseases (including Metabolic Dysfunction-Associated Steatohepatitis, MASH). MASH is a severe and progressive fatty liver disease affecting over 200 million people worldwide.
NewTimeSpace News: Simcere Pharmaceutical Group Limited (02096.HK) announced that SIM0613 for Injection, a self-developed antibody-drug conjugate (ADC) targeting LRRC15, has obtained the Clinical Trial Approval Notice issued by the National Medical Products Administration (NMPA). A clinical trial for advanced solid tumors is planned to be launched. Previously, Simcere Zaiming, a subsidiary of the Group, has signed an exclusive license agreement with Ipsen, entitling it to receive a total payment of up to USD 1.06 billion.
NewTimeSpace News: SSY Group Limited (02005.HK) announced that the Group has obtained the drug production registration approval issued by the National Medical Products Administration (NMPA) for Diltiazem Hydrochloride for Injection (10mg). Classified as a Class 4 chemical drug, it is deemed to have passed the consistency evaluation. Meanwhile, the Group has also secured registration approval for Propranolol Hydrochloride Injection (specifications: 5ml:5mg and 2ml:2mg). As a Class 3 chemical drug, it is also recognised as passing the consistency evaluation.
NewTimeSpace News: CSPC Pharmaceutical Group Limited (01093.HK) announced that SYS6051, developed by the Group, has been approved by the National Medical Products Administration (NMPA) to initiate clinical trials in China. The product is a tissue factor (TF)-targeted antibody-drug conjugate (ADC) and was filed as a Class 1 therapeutic biological product. The approved indication is advanced solid tumors.
