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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its drug Arcalyst (rilonacept), indicated for the treatment of cryo-pyrin-associated periodic syndromes (CAPSs), including familial cold autoimmune syndrome (FCAS) and muckle-well syndrome (MWS). Understanding CAPS and Its SubtypesCAPS is a…
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for Elahere (mirvetuximab soravtansine), an antibody drug conjugate (ADC) targeting folate receptor α (FRα), for the treatment of FRα positive platinum-resistant ovarian cancer (PROC) in patients who have…
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Sino-US firm MicuRx Pharmaceuticals Inc. (SHA: 688373) has announced positive results from a Phase III study for its drug MRX-4 in combination with contezolid as sequential therapy for complex skin and soft tissue infections. The study successfully met its primary efficacy endpoint, demonstrating good clinical and microbiological efficacy. The regimen’s…
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Shanghai-based Allink Biotherapeutics, a clinical-stage biotech company specializing in the development of bispecific antibodies (BsAbs) and antibody drug conjugates (ADCs), has reportedly raised $42 million via a Series A financing round. The funding round was led by Lanchi Ventures, with additional contributions from YuanBio Venture Capital, Legend Capital, and Xiamen…
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China-based Jiangsu Kanion Pharmaceutical Co., Ltd (SHA: 600557) has announced receiving separate clinical trial approvals from the National Medical Products Administration (NMPA) for its two Category 1 products: KYHY2302 cream for mild to moderate plaque psoriasis and KYHY2303 tablets for recurrent or refractory malignant hematological tumors. KYHY2302 Cream for Plaque…
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China-based biotech company BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has received a marketing approval from the European Commission (EC) for its programmed death-1 (PD-1) inhibitor, Tevimbra (tislelizumab). The drug is now approved for use in combination with chemotherapy for the first-line treatment of esophageal squamous cell carcinoma (ESCC)…
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that the National Medical Products Administration (NMPA) has approved another indication for its product Daxxify (daxibotulinumtoxin, RT002). The type A botulinum toxin is now approved for the treatment of adult cervical muscle tone disorders in China. Background on…
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Beijing-based Phil Rivers Technology Co.,Ltd, a high-tech platform company incubated by the Institute of Computing Technology, Chinese Academy of Sciences, has announced receiving Investigational New Drug (IND) approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for its Category 1 drug, PR00012. Phase I…
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China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) has announced that its fifth indication filing for Ameile (almonertinib) has been accepted for review by the National Medical Products Administration (NMPA). The epidermal growth factor receptor (EGFR) inhibitor is now under review for the first-line treatment of locally advanced or metastatic…
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China Medical System Holdings Ltd (CMS, HKG: 0867) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study in China. The study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of CMS-D005 in healthy and overweight and obese adult subjects. Dual…
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The Genesis RMN cardiac electrophysiological robot magnetic navigation system, represented in China by Shanghai Microport EP Medtech Co., Ltd, (SHA: 688351) has been granted marketing approval by the National Medical Products Administration (NMPA) in China. Global Recognition and Enhanced FeaturesDeveloped by Stereotaxis, the Genesis RMN system has already received approval…
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GSK plc (NYSE: GSK) has announced that it has received marketing approval from the European Commission (EC) for its Menveo vaccine, a Meningococcal Group A, C, W-135, and Y conjugate vaccine (MenACWY vaccine), in a single-vial, fully liquid presentation. This formulation is designed for the prevention of invasive meningococcal disease…
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China-based TenNor Therapeutics has entered into an exclusive commercialization cooperation agreement with compatriot firm Grand Life Sciences, appointing the latter as the sole commercial promotion service provider in mainland China, Hong Kong, and Macau for TenNor’s rifasutenizol (TNP-2198), a treatment for Helicobacter pylori (H. pylori) infection. Financial Terms and ResponsibilitiesUnder…
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Beijing-based biotech company Immunochina Pharmaceuticals has announced that the National Medical Products Administration (NMPA) has accepted for review the New Drug Application (NDA) for its chimeric antigen receptor T cell (CAR-T) product, IM19. The therapy is being sought for the treatment of relapsed or refractory diffuse large B-cell lymphoma (r/r…
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China-based Thederma has announced that its TAP-1503 cream has been granted approval by the National Medical Products Administration (NMPA) with priority review status. The drug, containing 1% tapinarof as a small molecule chemical drug, is now approved for the treatment of atopic dermatitis (eczema) in children over two years old…
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Swiss pharmaceutical company Novartis (NYSE: NVS) has announced that it has received marketing approval from the European Commission (EC) for its CDK4/6 inhibitor Kisqali (ribociclib) in combination with an aromatase inhibitor (AI) for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early…
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Global healthcare company Sanofi (NASDAQ: SNY) has inaugurated Modulus, its state-of-the-art manufacturing facility in Singapore. This facility, which employs an ‘industry first’ modular concept, is designed to offer flexible manufacturing capabilities for the production of next-generation vaccines and biological medicines. Investment and Capabilities of ModulusThe SGD 800 million (USD 558…
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China-based Chia Tai Tianqing has announced that the National Medical Products Administration (NMPA) has granted another indication approval for its anti-programmed death-ligand 1 (PD-L1) monoclonal antibody (mAb) benmelstobart (TQB2450). The drug is now approved in combination with the multi-target kinase inhibitor anlotinib to treat patients with non-Microsatellite Instability-High (non MSI-H)…
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), a China-based biopharmaceutical company, has received market approval from the National Medical Products Administration (NMPA) for its drug sacituzumab tirumotecan (SKB264/MK-2870). This drug is intended to treat adult patients with unresectable locally advanced or metastatic triple negative breast cancer (TNBC) who have previously…
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Shanghai-based CORXEL, formerly known as Ji Xing Pharmaceuticals, supported by RTW Investments, has received approval from China’s National Medical Products Administration (NMPA) for its varenicline nasal spray, which is indicated for increasing tear secretion in patients diagnosed with xerophthalmia. Clinical Studies Support NMPA ApprovalThe NMPA’s approval was grounded in data…