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Chia Tai Tianqing Launches NPP for Urgent Cancer Treatment in Hong Kong
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China-based Chia Tai Tianqing Pharmaceutical has entered into a Named Patient Program (NPP) collaboration with the Greater China Cancer Foundation. This partnership aims to provide innovative treatment solutions for patients with urgent medical needs in Hong Kong. NPP MechanismThe NPP in Hong Kong is a special mechanism designed to assist…
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Innovent Biologics’ IBI363 Granted Breakthrough Therapy Designation for Melanoma
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China-based Innovent Biologics, Inc. (HKG: 1801) announced that it has received breakthrough therapy designation (BTD) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for its investigational drug IBI363. The designation is for the treatment of unresectable locally advanced or metastatic mucosal or acral melanoma…
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Hengrui’s HRS-5965 Granted Breakthrough Therapy Designation for IgA Nephropathy
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced that it has received breakthrough therapy designation (BTD) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for its investigational drug HRS-5965. The designation is for the treatment of primary IgA nephropathy, the most common primary…
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Sanofi’s Dupixent Approved in Japan for Chronic Obstructive Pulmonary Disease
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Sanofi (EPA: SAN, NASDAQ: SNY) announced that it has received approval from Japan’s Ministry of Health, Labour and Welfare for Dupixent (dupilumab) for the treatment of chronic obstructive pulmonary disease (COPD) in adults whose disease is not adequately controlled with existing therapy. This marks a significant expansion of Dupixent’s therapeutic…
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Pacific Shuanglin Bio-pharmacy Partners with XtalPi for Blood Product Innovation
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China-based Pacific Shuanglin Bio-pharmacy Co., Ltd (SHE: 000403) has formed a strategic partnership with Shenzhen-based XtalPi Holdings Limited (HKG: 2228). The collaboration aims to enhance technological innovation and drive high-quality development in the blood products industry through joint efforts in new product development, research, and intelligent management of production quality.…
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Novartis’ Pluvicto Gains Expanded FDA Approval for Prostate Cancer Treatment
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Swiss pharmaceutical giant Novartis (NYSE: NVS) announced that it has received expanded indication approval from the US Food and Drug Administration (FDA) for its radioligand therapy (RLT) Pluvicto (lutetium Lu 177 vipivotide tetraxetan). The PSMA-targeted therapy is now approved for PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) patients who have been…
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EMA’s CHMP Issues Negative Opinion on Lilly’s Kisunla for Alzheimer’s
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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a negative opinion last week regarding the approval of Eli Lilly and Company’s (NYSE: LLY) Kisunla (donanemab) for the treatment of early Alzheimer’s disease (AD). Despite this setback, the US pharmaceutical giant stated that…
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uBriGene Appoints Dr. Joy Zhou to Lead Cell Therapy Development
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China-based advanced therapy medicinal product (ATMP) contract development and manufacturing organization (CDMO) uBriGene Biosciences announced the appointment of Dr. Joy Zhou as Vice President of Cell Therapy. In her new role, Dr. Zhou will oversee the development of the company’s cell therapy production technology platform, cGMP production, and quality control.…
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BMS’s Opdivo/Yervoy Combo Approved by NMPA for First-Line HCC Treatment
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Bristol-Myers Squibb (BMS, NYSE: BMY) announced that it has received approval from China’s National Medical Products Administration (NMPA) for its anti-PD-1 drug Opdivo (nivolumab) in combination with Yervoy (ipilimumab) as a first-line treatment for unresectable or advanced hepatocellular carcinoma (HCC). This approval makes the Opdivo/Yervoy combination the first and currently…
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Roche’s Ocrevus Approved by China’s NMPA for Multiple Sclerosis Treatment
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Swiss pharmaceutical giant Roche (SWX: ROG, OTCMKTS: RHHBY) announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its selective immunosuppressant Ocrevus (ocrelizumab). The drug is approved for the treatment of adults with recurrent multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting multiple sclerosis, and…
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Shanghai Bio-heart Launches SAKURA-SCB Study for Drug-Coated Balloon in Japan
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China-based Shanghai Bio-heart Biological Technology Co., Ltd (HKG: 2185) announced the first patient enrollment for the SAKURA-SCB study at the Cardiovascular Institute in Tokyo, Japan. This single-blinded, multiple comparison study aims to evaluate the efficacy and safety of the company’s investigational drug-coated balloon (DCB) with rapamycin. DCB InnovationThe DCB, designed…
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AstraZeneca’s Imfinzi Approved by FDA for Bladder Cancer Treatment
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The US Food and Drug Administration (FDA) has approved AstraZeneca’s (NASDAQ: AZN) PD-L1 inhibitor Imfinzi (durvalumab) for use in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by single-agent durvalumab as adjuvant treatment after radical cystectomy, for adults with muscle-invasive bladder cancer (MIBC). Clinical Trial ResultsThe approval is supported…
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MicroPort Endovascular Reports 1.61% Revenue Growth in 2024 with Strong Profit Increase
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Shanghai MicroPort Endovascular MedTech Co., Ltd (SHA: 688016) released its 2024 financial report, showing a revenue of RMB 1.206 billion (USD 166.3 million), a 1.61% year-on-year (YOY) increase. Operating profit reached RMB 661 million (USD 91.1 million), up 15.22% YOY, while net profit was RMB 502 million (USD 69.2 million),…
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Luye Pharma Group Reports 2024 Revenue Dip Despite Growth in Product Sales
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China-based Luye Pharma Group (HKG: 2186) announced its 2024 financial performance, recording RMB 6.061 billion (USD 836 million) in revenues, a 1.3% year-on-year (YOY) decline. This decrease was primarily due to reduced income from non-product sales, such as research and development (R&D) services. However, product sales showed resilience, growing 1.1%…
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Hengrui Pharmaceuticals Reports 22.63% Revenue Growth in 2024 with Strong Innovative Drug Sales
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) released its 2024 financial report, recording RMB 27.985 billion (USD 3.86 billion) in revenues, a 22.63% year-on-year (YOY) increase. The net profit attributable to shareholders of the listed company was RMB 6.337 billion (USD 873.7 million), up 47.28% YOY. Sales of innovative…
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Sanofi’s Qfitlia Approved by FDA for Hemophilia A and B Prophylaxis
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France-based Sanofi (EPA: SAN, NASDAQ: SNY) has announced receiving marketing approval from the US Food and Drug Administration (FDA) for Qfitlia (fitusiran). This antithrombin-lowering (AT) therapy is now approved for routine prophylaxis to prevent or reduce bleeding episodes in adult and pediatric patients (aged 12 or older) with hemophilia A…
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Brii Biosciences Presents Elebsiran Phase II Data at APASL 2025 Meeting
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China-based Brii Biosciences Ltd (HKG: 2137) has published the latest data from its ongoing Phase II ENSURE study for elebsiran (BRII-835, VIR-2218) at the 34th Annual Meeting of the Asian Pacific Association for the Study of the Liver (APASL 2025). Elebsiran, an investigational small interfering ribonucleic acid (siRNA), is being…
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Akeso Biopharma Reports 53% Revenue Decline in 2024 Despite Growth in Product Sales
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China-based Akeso Biopharma (HKG: 9926) released its 2024 financial report, recording RMB 2.124 billion (USD 293 million) in revenues, a 53.08% year-on-year (YOY) decrease. Despite the overall revenue decline, product sales grew significantly to RMB 2 billion (USD 276 million), up 24.88% YOY. Licensing income was reported at RMB 121.6…
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IASO Biotherapeutics’ Fucaso Approved in Macao for Relapsed Multiple Myeloma
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China-based IASO Biotherapeutics announced that the New Drug Application (NDA) for its BCMA-targeted chimeric antigen receptor (CAR) T cell therapy Fucaso (equecabtagene autoleucel) has been approved by the Pharmaceutical Administration Bureau of the Macao Special Administrative Region (ISAF). This approval marks the first NDA approval for Fucaso outside of mainland…
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Eli Lilly Launches Kisunla in China for Early Alzheimer’s Treatment
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US pharmaceutical giant Eli Lilly and Company (NYSE: LLY) has officially launched Kisunla (donanemab) in China, a Category 1 drug approved in December last year for treating early symptomatic Alzheimer’s disease (AD). This includes adults with mild cognitive impairment (MCI) and mild dementia stage AD. Therapy DetailsKisunla is administered as…
