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China-based Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317) has announced that it has received conditional marketing approval from the National Medical Products Administration (NMPA) for its drug candidate RAY1216, a 3CL protease (3CLpro) inhibitor. The drug is set to be assessed as a treatment for mild to moderate COVID-19. Mechanism…
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its investigational drug HRS-5965. The study will focus on complement-mediated hemolytic anemia, including conditions such as paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic…
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China-based Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd, a subsidiary of 3SBio Inc. (HKG: 1530), has announced the completion of patient enrollment in a China-based Phase II clinical study for its SSGJ-611, an IL-4Rα monoclonal antibody (mAb). The drug is being evaluated as a treatment for moderate to severe atopic dermatitis…
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Shanghai Henlius Biotech (HKG: 2696) has announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for its programmed death-1 (PD-1) inhibitor, HanSiZhuang (serplulimab). The drug is filed for its first indication as a first-line treatment in combination with chemotherapy for extensive-stage small cell lung cancer…
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Sino Biopharmaceutical Ltd (HKG: 1177) has announced a second licensing agreement between its recently acquired subsidiary, F-star Therapeutics Inc. (NASDAQ: FSTX), and Japan-based Takeda Pharmaceutical Co., Ltd (TYO: 4502). The deal provides Takeda with a next-generation tumor immunotherapy bispecific antibody (BsAb), with the specific target or other molecule details undisclosed.…
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AstraZeneca (AZ, NASDAQ: AZN) has announced that it has received conditional market approval in China for its next-generation Bruton’s tyrosine kinase (BTK) inhibitor, Calquence (acalabrutinib). The drug is approved for the first indication in adults with mantle cell lymphoma (MCL) who have received at least one prior therapy. Clinical Trial…
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US-based Biohaven Ltd. (NYSE: BHVN) has announced the acquisition of global rights, excluding China regions, for the development of an oral, brain-penetrant, dual inhibitor of Tyrosine Kinase 2 (TYK2) and Janus Kinase 1 (JAK1) for the treatment of brain disorders. The compound, BHV-8000 (previously TLL-041), was licensed from Hangzhou Highlightll…
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Chengdu-based biotech Hinova Pharmaceuticals Inc. (SHA: 688302) has announced that the New Drug Application (NDA) filing for its Category 1 drug HC-1119 has been accepted for review by the National Medical Products Administration (NMPA). The intended indication is for patients with metastatic castrate-resistant prostate cancer (mCRPC) who have failed to…
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German pharmaceutical giant Boehringer Ingelheim (BI) has announced the first patient enrollments in the Phase III FIBRONEER studies for its phosphodiesterase 4b (PDE4B) inhibitor, BI 1015550. The studies are focused on idiopathic pulmonary fibrosis (IPF) and progressive fibrosis interstitial lung disease (PF-ILD), two conditions with limited treatment options. Global Study…
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China-based Grand Pharmaceutical Group Limited (HKG: 0512) published its 2022 financials, reporting revenues of HKD 9.562 billion (USD 1.2 billion) over the 12 months, marking a 15.1% increase year-on-year (YOY). The net profit attributable to equity holders reached HKD 2.14 billion (USD 272 million), up 15.4% YOY. The company invested…
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China-based Ascentage Pharma (HKG: 6855) has announced its 2022 financial results, marking the first year of commercial sales for olverembatinib (HQP1351). The third-generation BCR-ABL-targeted tyrosine kinase inhibitor (TKI) was approved in November 2021 to treat TKI-resistant chronic-phase CML (CML-CP) or accelerated-phase CML (CML-AP) with the T315I mutation. The company recorded…
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China-based Ping An Healthcare and Technology Co., Ltd (HKG: 1833), also known as Ping An Good Doctor, released its 2022 financial report. The company recorded revenues of RMB 6.16 billion (USD 902.9 million) throughout the year, marking a 16.01% decrease year-on-year (YOY). Losses narrowed to RMB 611 million (USD 89.5…
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JD Healthcare, a unit of China’s e-commerce giant JD.com (NASDAQ: JD), released its 2022 financial report, showing total revenues of RMB 46.7 billion (USD 6.84 billion), a 52.3% increase year-on-year (YOY). As of December 31, 2022, the platform had more than 154 million annual active users, with healthcare daily inquiries…
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China-based WuXi Biologics (HKG: 2269) released its 2022 financial report for the period ending December 31, 2022. The Contract Development and Manufacturing Organization (CDMO) reported total income of RMB 15.27 billion (USD 2.237 billion), marking a 48.4% increase year-on-year (YOY). Net profits also rose by 47.1% YOY, reaching RMB 5.05…
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The Center for Drug Evaluation (CDE) website indicates that Advenchen Lab’s AL8326 and Hengrui Pharmaceuticals’ (SHA: 600276) SHR-A1811 have been awarded separate breakthrough therapy designations (BTDs). This recognition highlights the potential of both drugs to significantly improve the treatment of cancer patients. Advenchen’s AL8326: A Promising TKI InhibitorAdvenchen’s drug candidate…
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Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK) and the Peking University School of Public Health have officially initiated public health projects aimed at training young and middle-aged backbone talent. This collaboration seeks to enhance the skills and knowledge of professionals in the public health sector, contributing to the development…
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China-based Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study assessing the efficacy and safety of its drug candidate BL-B01D1 as a treatment for solid tumors. The study will evaluate the…
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China-based Junshi Biosciences (HKG: 1877, SHA: 688180) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its JS010, an in-house developed CGRP-targeted monoclonal antibody (mAb) drug candidate for the treatment of migraines. CGRP and Its Role in MigrainesCGRP is a neuropeptide composed…
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China-based chimeric antigen receptor T-cell (CAR-T) specialist Immunotech Biopharm Ltd (HKG: 6978) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its CAR-T-19-D2 (CAR-T-19-DNR or RC19D2) in recurrent/refractory diffuse large B-cell lymphoma (DLBCL). Mechanism of Action and Clinical NeedCAR-T-19-D2 targets the CD19…
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UK-based Smith & Nephew Plc has announced a strategic partnership with China’s Shanghai Fudong Medical Management Co., Ltd, also known as MedMotion, a leading digital health company. This collaboration aims to enhance digitalization innovation and explore comprehensive “pre-operative, intraoperative, and post-operative” perioperative management solutions. Aim to Revolutionize Post-Operative RehabilitationThe partnership…