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CARsgen Therapeutics Administers KJ-C2219 in SLE Patient in IIT
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China-based CARsgen Therapeutics Holdings Ltd (HKG: 2171) announced that it has administered its KJ-C2219 at the starting dose specified in the clinical protocol in the first patient with systemic lupus erythematosus (SLE) in an investigator-initiated trial (IIT). Therapy DetailsKJ-C2219, an allogeneic CAR-T therapy targeting CD19/CD20, was developed via CARsgen’s THANK-u…
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Adagene Starts Phase II Trial of Muzastotug for Colorectal Cancer
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China-based Adagene Inc. (NASDAQ: ADAG) announced the initiation of an Investigator-Initiated (IIT) Phase II trial for muzastotug (ADG126) as a neoadjuvant therapy for patients with stage II or stage III colorectal cancer. Drug ProfileMuzastotug is a masked, anti-CTLA-4 SAFEbody that targets a unique epitope of CTLA-4 in regulatory T cells…
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Shanghai Moyang Biotech’s Aphranel CC Needle Wins NMPA Approval
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China-based Shanghai Moyang Biotechnology Co., Ltd, an innovation-focused company in nanomedical biomaterials and Class III absorbable implants, announced it has received a Category III medical device license from the National Medical Products Administration (NMPA) for its Aphranel CC needle. The high-end medical aesthetics product is used for subcutaneous injection of…
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Huadong Medicine’s ADC HDM2005 Granted FDA Orphan Drug Designation for MCL
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China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that its antibody-drug conjugate (ADC) HDM2005 has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of mantle cell lymphoma (MCL). Drug Mechanism and Preclinical ResultsPreclinical studies have shown that after HDM2005 enters the…
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EpimAb and Medigene Team Up on TCR-TCE Therapy for Immune-Related Diseases
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EpimAb Biotherapeutics, Inc. and Medigene AG (ETR: MDG1) today announced a strategic collaboration agreement to research and develop T cell receptor (TCR)-mediated T cell engager therapy (TCR-TCE) for the treatment of immune-related diseases, including solid tumors. Partnership DetailsThe partnership integrates the expertise of both companies across multiple targets. Medigene brings…
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AstraZeneca’s Camizestrant Shows Promise in SERENA-6 Breast Cancer Study
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UK-based pharmaceutical giant AstraZeneca (NASDAQ: AZN) announced positive interim analysis results from the Phase III SERENA-6 study for its camizestrant, a next-generation oral selective estrogen receptor degrader (SERD) and complete ER antagonist. Study Details and ResultsThe study evaluated switching to camizestrant in combination with a cyclin-dependent kinase (CDK) 4/6 inhibitor…
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Bayer’s Gadoquatrane Shows Positive Results in Phase III QUANTI CNS Study
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German pharmaceutical giant Bayer (ETR: BAYN) announced positive results from the Phase III QUANTI CNS study for its gadoquatrane, a gadolinium-based contrast agent (GBCA), in adults with known or suspected pathologies of the central nervous system undergoing contrast-enhanced magnetic resonance imaging (MRI). Study Details and ResultsIn the trials, gadoquatrane was…
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Ping An Good Doctor Launches AI-Powered Digital Doctor Service
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China-based Ping An Healthcare and Technology Co., Ltd (HKG: 1833), also known as Ping An Good Doctor, announced the launch of “Ping An Xin Yi,” an AI-powered digital doctor service integrated within its Ping An Health APP. The service offers 24/7 access to AI-assisted health consultations, marking a significant step…
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Eli Lilly to Establish Four New US Pharma Manufacturing Sites
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US major Eli Lilly & Co. (NYSE: LLY) announced plans to establish four new pharmaceutical manufacturing sites in the United States. The move aims to boost the company’s domestic medicine production across various therapeutic areas. API Manufacturing and Supply Chain StrengtheningThree of the new sites will focus on manufacturing active…
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Precigen’s RRP Therapy PRGN-2012 Gets FDA Review
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US-based cell and gene therapy (CGT) specialist Precigen, Inc. (NASDAQ: PGEN) announced that the US Food and Drug Administration (FDA) has accepted a biologics license application (BLA) for its zopapogene imadenovec (PRGN-2012) for the treatment of adults with recurrent respiratory papillomatosis (RRP). The agency is expected to act on the…
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Burning Rock and MGI Tech Partner to Advance Oncology Precision Medicine
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China-based medtech firm Burning Rock Ltd (NASDAQ: BNR) has entered into a strategic partnership with fellow domestic company MGI Tech Co., Ltd (SHA: 688114), a gene sequencing specialist. The collaboration aims to promote the clinical application and global business development of oncology precision medicine, with a focus on regulatory filing…
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Cell Store and Cygenta Forge Strategic Alliance in Cell and Gene Therapy Field
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Beijing-based biotech firms Cell Store, a biological sample cryopreservation technology platform, and Cygenta, a Contract Development and Manufacturing Organization (CDMO) specializing in cell and gene therapy (CGT), have entered into a long-term strategic alliance. Financial terms of the partnership were not disclosed. Partnership DetailsThe alliance aims to leverage Cell Store’s…
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InnoCare Pharma’s Orelabrutinib Shows Efficacy in RRMS at ACTRIMS Forum
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Beijing-based InnoCare Pharma (HKG: 9969, SHA: 688428) announced the presentation of Phase II study results for its Bruton’s tyrosine kinase (BTK) inhibitor orelabrutinib in relapsing-remitting multiple sclerosis (RRMS) at the 10th annual Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum. Study HighlightsThe data demonstrated significant efficacy of…
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Jiangsu Hengrui’s HRS-1301 Receives NMPA Approval for Hyperlipidemia
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced that its Category 1 chemical drug HRS-1301 has received clinical trial approval from the National Medical Products Administration (NMPA) for the treatment of hyperlipidemia. Clinical Approval DetailsThe approval marks a significant milestone for HRS-1301, a novel drug designed to address hyperlipidemia.…
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Hepalink Pharmaceutical’s Enoparin Receives Argentina Approval for Thromboembolic Diseases
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China-based Shenzhen Hepalink Pharmaceutical Group Co., Ltd (SHE: 002399) announced that its subsidiary, Shenzhen Techdow Pharmaceutical Co., Ltd, has received marketing approval from Argentina’s Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) for its Enoparin (enoxaparin) product. The approved specifications include 0.2ml: 20mg, 0.4ml: 40mg, 0.6ml: 60mg, and 0.8ml:…
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Bio-heart’s Iberis System Approved by NMPA for Hypertension Treatment
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China-based Shanghai Bio-heart Biological Technology Co., Ltd (HKG: 2185) announced that its subsidiary, Shanghai Angiocare Medical Technology Co., Ltd, has received market approval from the National Medical Products Administration (NMPA) for its multipole renal arterial radiofrequency ablation system, Iberis. The device is approved as an adjuvant therapy for refractory hypertension…
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Fosun Pharma’s Tenapanor Approved in China for CKD Dialysis Patients
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its tenapanor, an innovative phosphate absorption inhibitor, in China. The drug, commercially known as Wan Ti Le, is now available for controlling serum phosphorus levels…
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WuXi XDC Expands MOU with LigaChem to Advance Next-Gen ADC Development
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WuXi XDC (HKG: 2268), a joint venture between Wuxi Biologics (HKG: 2269) and WuXi STA, a subsidiary of WuXi AppTec Co., Ltd (HKG: 2359, SHA: 603259), has signed an expanded Memorandum of Understanding (MOU) with South Korea’s LigaChem Biosciences, Inc. to accelerate the development of next-generation antibody drug conjugates (ADCs).…
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Kexing Biopharm and Bio-Sincerity Pharmaceutical Form Strategic Alliance
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China-based Kexing Biopharm Co., Ltd. (SHA: 688136) and Hangzhou Bio-Sincerity Pharmaceutical Technology Co., Ltd. (SHE: 301096) have entered into a strategic partnership to collaborate on innovative drug development and overseas commercialization. Partnership DetailsThe alliance aims to leverage the strengths of both companies in drug development and commercialization. The partnership will…
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Harbour BioMed Licenses HAT001/HBM9013 to Global Partner for CRH-Targeted Therapy
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China-based Harbour BioMed (HKG: 2142) announced a strategic collaboration and licensing agreement with an undisclosed partner to advance the development of HAT001/HBM9013, a novel corticotropin releasing hormone (CRH) targeted therapy. The alliance aims to promote the drug’s development globally, excluding Greater China. Agreement DetailsUnder the agreement, the partner will hold…
