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Sihuan Pharmaceutical’s KM501 Receives Clinical Trial Approval for HER2-Positive Tumors
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China-based Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its XZP-KM501 (KM501) in solid tumors with HER2 positive, middle to low-expression. This marks a significant step forward in the development of innovative treatments for…
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4B Technologies’ FB1001 Receives CDE Approval for Clinical Trials
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China-based 4B Technologies Investments Ltd has announced that it has received clinical trial approval from the Center for Drug Evaluation (CDE) for its potential first-in-class monoclonal antibody (mAb) FB1001 (ZG103). This marks a significant milestone in the development of the drug candidate, which was developed by the company’s founder, Dr.…
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RemeGen’s RC48 Receives Two Clinical Trial Approvals for Breast Cancer Treatments
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RemeGen Ltd (HKG: 9995) has announced the receipt of two clinical trial approvals for its antibody-drug conjugate (ADC) candidate RC48 (disitamab vedotin). The Chinese firm is set to assess the drug as a neo-adjuvant therapy for HR-positive, HER2 low-expression breast cancer, either in combination with Junshi Bio’s (HKG: 1877, SHA:…
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China’s Plan to Strengthen Medical and Healthcare Service System Unveiled
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The General Office of the CPC Central Committee and State Council has released the “Opinions on Ramping up Medical and Healthcare Service System,” outlining five major aspects to enhance the country’s healthcare infrastructure. 1. Optimize Resource Allocation and Strengthen Capacity ModernizationThe plan emphasizes optimizing resource allocation and strengthening talent team…
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Alphax Bio Raises Millions for Spatial Proteomics and Tumor Immune Microenvironment Research
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Beijing-based Alphax Bio, a developer of immune-testing technologies, has reportedly raised “tens of millions” of renminbi in a recent financing round, led solely by Cui Capital. The funds will be directed towards the clinical transformation of spatial proteomics tumor immune microenvironment assessment, the development of functional proteomics solutions, and the…
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Luye Pharma’s Lurbinectedin Gains Priority Review Status for SCLC Treatment
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The Center for Drug Evaluation (CDE) website indicates that China-based Luye Pharma Group’s (HKG: 2186) lurbinectedin (LY01017), an RNA polymerase II inhibitor, is set to obtain priority review status for the treatment of metastatic small cell lung cancer (SCLC) with tumor progression during or after platinum-based chemotherapy. Development and Mechanism…
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Guangdong Zhongsheng’s RAY1216 Receives Conditional Approval for COVID-19 Treatment
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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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Hengrui Pharmaceuticals’ HRS-5965 Receives NMPA Approval for Clinical Study in Hemolytic Anemia
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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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Sunshine Guojian Completes Patient Enrollment for SSGJ-611 Phase II Study in Atopic Dermatitis
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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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Henlius Biotech’s Serplulimab Accepted for EMA Review for ES-SCLC Treatment
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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’s F-star Therapeutics Signs Second Licensing Deal with Takeda
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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’s Calquence Receives Conditional Approval in China for MCL
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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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Biohaven Acquires Global Rights for Dual TYK2/JAK1 Inhibitor BHV-8000 from Highlightll
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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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Hinova Pharmaceuticals’ HC-1119 NDA Accepted for Review by NMPA
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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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Boehringer Ingelheim Initiates Phase III FIBRONEER Studies for PDE4B Inhibitor BI 1015550
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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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Grand Pharmaceutical Group Reports 15.1% Revenue Growth in 2022 Financials
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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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Ascentage Pharma’s 2022 Revenue Soars with Olverembatinib Sales
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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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Ping An Good Doctor Reports Revenue Decline but Medical Services Growth in 2022
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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 Reports 52.3% Revenue Growth in 2022 Financial Report
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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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WuXi Biologics Reports 48.4% Revenue Growth in 2022 Financial Report
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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…
