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US-based Keros Therapeutics, Inc. (NASDAQ: KROS) has announced a significant licensing agreement with Japan-headquartered Takeda (TYO: 4502) to strengthen the research and development of its late-stage investigational activin inhibitor, elritercept. Elritercept’s Clinical Studies and IndicationsElritercept is currently the subject of two clinical studies, one focusing on myelodysplastic syndromes (MDS) and…
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US-based Gilead Sciences Inc., (NASDAQ: GILD) has announced an exclusive option and license agreement with Tubulis GmbH, a German firm. This agreement grants Gilead access to Tubulis’ proprietary Tubutecan and Alco5 platforms for the joint development of an antibody-drug conjugate (ADC) targeting solid tumors. Financial Terms and Milestones of the…
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Cloudbreak Pharma Inc., a Cayman Island-registered ophthalmology biotech company, has filed for an initial public offering (IPO) on the Hong Kong Stock Exchange, with major details undisclosed at this stage. This marks the company’s third attempt to go public, following previous efforts in November 2023 and May 2024. Innovative Pipeline…
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US-based COUR Pharmaceutical has announced a strategic collaboration and licensing agreement with Genentech, a member of the Roche Group, to develop and commercialize COUR’s proprietary tolerogenic nanoparticle treatments aimed at addressing an autoimmune disease. Financial Terms and Milestones of the AgreementAccording to the agreement, COUR is set to receive upfront…
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Guangzhou Virotech Pharmaceutical Co., Ltd., a China-based pharmaceutical company, has announced receiving tacit clinical approval from the National Medical Products Administration (NMPA) for its oncolytic virus therapy, M1 (VRT106). This approval paves the way for an imminent Phase I clinical study in China, which will assess the safety, tolerability, pharmacokinetics,…
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France-based Ipsen (OTCMKTS: IPSEY) has announced a significant global licensing agreement with compatriot firm Biomunex Pharmaceuticals concerning the latter’s T cell engager (TCE), BMX-502. Ipsen is poised to secure exclusive development, manufacturing, and commercialization rights for BMX-502 across global territories. Responsibilities and Milestones Under the AgreementUnder the terms of the…
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US-based OncoC4, Inc. has announced that it has received clinical clearance from the US Food and Drug Administration (FDA) for its innovative bispecific antibody, AI-081, which targets both PD-1 and VEGF pathways. Composition and Mechanism of AI-081AI-081 is composed of proprietary high-affinity clinical-stage anti-PD-1 (AI-025) and anti-VEGF (AI-011) antibodies. This…
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China-based Luye Pharma Group (HKG: 2186) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its drug Zepzelca (lurbinectedin) with priority review status. This approval allows the use of Zepzelca to treat adult patients with metastatic small cell lung cancer (SCLC) who are…
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Sacituzumab tirumotecan (SKB264/MK-2870), a TROP2-targeted antibody drug conjugate (ADC) co-developed by Merck, Sharp & Dohme (MSD, NYSE: MRK) and Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), has been granted a breakthrough therapy designation (BTD) by the US FDA. This designation is for the treatment of non-small cell lung cancer (NSCLC)…
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US pharmaceutical major Merck, Sharp & Dohme Inc., (MSD; NYSE: MRK) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its combination antibacterial drug, Recarbrio (imipenem, cilastatin, and relebactam). This new treatment is indicated for patients aged 18 years and older with hospital-acquired…
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Shanghai-based biotech company Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase I study for its small molecule inhibitor, ABSK131. This investigational drug targets PRMT5 and MTA in patients with advanced solid tumors that…
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The National Drug Alliance Procurement Office has issued a notification to suspend the manufacturing and marketing of piracetam by Zhuhai Hefan Medicine Co., Ltd. The suspension comes as a result of severe defects found in the company’s manufacturing management process, which are in direct violation of the Good Manufacturing Practice…
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China-based InventisBio (Shanghai) Co., Ltd (SHA: 688382) has announced the successful completion of a Phase II study for its oral TYK2 inhibitor, D-2570, in the treatment of psoriasis, with positive outcomes. Understanding Psoriasis and the Role of TYK2 InhibitionPsoriasis is an immune-mediated chronic disease characterized by recurrent, inflammatory, and systemic…
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Shanghai Henlius Biotech Inc., (HKG: 2696) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its anti-programmed death-1 (PD-1) inhibitor, HanSiZhuang (serplulimab, HLX10), marking its fifth indication approval in China. The drug can now be used in combination with pemetrexed and carboplatin as…
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Zhejiang Huahai Pharmaceutical Co., Ltd. (SHA: 600521), through its subsidiary Shanghai Huaota Biopharmaceutical Co., Ltd., has announced the first subject dosing in a clinical study for its potential first-in-class drug, HB0056, in New Zealand. This marks a significant step forward in the development of this innovative therapy. HB0056: A Bispecific…
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Chinese firms HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) and Innovent Biologics, Inc. (HKG: 1801) have jointly announced that they have received conditional approval from the National Medical Products Administration (NMPA) for the combination of Fruzaqla (fruquintinib) and Tyvyt (sintilimab). This treatment is intended for patients with advanced endometrial cancer…
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China-based Acotec Scientific Holdings Ltd (HKG: 6669) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its AcoArt Camellia, a paclitaxel-releasing coronary balloon dilation catheter. This medical device is now approved for the treatment of primary coronary artery disease in patients with vessel…
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Taiwan-based biotechnology company REGiMMUNE Ltd has announced the signing of an out-license agreement with San Fu Biotech (SFB), a subsidiary of San Fu Chemical Co., Ltd (TPE: 4755). Under the terms of the deal, REGiMMUNE will transfer the development and commercial rights of its pipeline candidate, RGI-2001, to SFB for…
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Suzhou-based gene editing specialist AccurEdit Therapeutics has announced positive results from an ongoing investigator-initiated trial (ITT) for its in vivo gene editing product, ART001. This lipid nanoparticle (LNP) delivered treatment is designed for transthyretin amyloidosis (ATTR), a rare, progressive, and fatal disease. In subjects who completed at least 48 weeks…
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French pharmaceutical company Sanofi (NASDAQ: SNY) has announced plans to invest EUR 1 billion (USD 1.05 billion) in the construction of a new manufacturing plant in the Beijing Economic-Technological Development Area. This marks the company’s largest investment in China to date. Expanding Local Manufacturing Capacities for InsulinThe new facility will…