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Suzhou Ribo Life Science Receives EU Approval for Phase II Trial of RBD5044
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Suzhou Ribo Life Science Co., Ltd. and its subsidiary Ribocure Pharmaceuticals AB have announced that their novel siRNA drug, RBD5044, has received approval to commence Phase II clinical trials in the European Union. This represents a significant step forward in the development of RNA interference therapies targeting lipid metabolism. RBD5044:…
Ascentage Pharma Submits Application for Lisaftoclax, a Novel Oral Bcl-2 Inhibitor
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Ascentage Pharma (HKG: 6855) has announced that its proprietary oral Bcl-2 selective inhibitor, Lisaftoclax (APG-2575), has submitted its market application, which has been officially accepted by regulatory authorities. The formulation is being produced in collaboration with Xuantai Pharmaceutical. This innovative treatment targets patients suffering from refractory or relapsed chronic lymphocytic…
C-Ray Therapeutics Secures Over $100 Million in A+ Round Financing
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C-Ray Therapeutics (Chengdu) Co., Ltd., an innovative enterprise in the field of radioactive medicines, has successfully completed over $100 million in A+ round financing. This funding round was jointly led by Shenzhen Capital Group’s New Materials Fund and Tailong Investment, with participation from notable investors including Hillhouse Ventures, SiBiono GeneTech,…
Bliss Bio Secures NMPA Approval for BB-1712, Pioneering ADC Therapy
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Bliss Bio announced that its Investigational New Drug (IND) application for the innovative antibody-drug conjugate (ADC) BB-1712 has been approved by the National Medical Products Administration (NMPA) of China. BB-1712, a B7-H3 targeted ADC utilizing Eribulin as its cytotoxic agent, has been developed for the treatment of multiple solid tumors,…
Merck KGaA Reports 3.8% Organic Growth in Q3 2024 Financials
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Merck KGaA (NYSE: MRK), the German multinational science and technology company, has released its financial results for the third quarter of 2024, reporting net sales of EUR 5.266 billion (USD 5.55 billion), marking an organic growth of 3.8%. The company’s performance reflects a steady increase in sales across its business…
Impact Therapeutics Secures $34.5 Million in Series D++ Financing for Senaparib Commercialization
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China-based biopharmaceutical company Impact Therapeutics has reportedly secured RMB 250 million (USD 34.5 million) in a Series D++ financing round, co-led by a globally renowned industry investment institution and a prominent insurance fund. The funds raised will be directed towards the commercialization of its core product, senaparib, a PARP1 inhibitor,…
GSK’s Blenrep Shows Survival Benefit in Phase III Multiple Myeloma Study
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UK-based pharmaceutical company GSK plc (NYSE: GSK) has reported positive results from a Phase III trial for Blenrep (belantamab mafodotin) in combination with bortezomib plus dexamethasone (BorDex) as a second-line or later treatment for relapsed or refractory multiple myeloma (RRMM). The DREAMM-7 head-to-head study demonstrated that GSK’s BCMA-targeted antibody drug…
Janssen-Cilag’s Nipocalimab Shows Promise in Phase II Study for Sjögren’s Disease
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Janssen-Cilag International NV, a subsidiary of Johnson & Johnson (J&J, NYSE: JNJ), has unveiled the latest analysis results from the Phase II DAHLIAS study for nipocalimab, an investigational FcRn blocker, in adult patients with moderate-to-severe Sjögren’s disease (SjD). The study has shown that the drug significantly improved key measures of…
Sanofi’s Sarclisa Receives CHMP Recommendation for Newly Diagnosed Multiple Myeloma
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French pharmaceutical giant Sanofi (NASDAQ: SNY) has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for the treatment of adult patients with…
J&J MedTech Secures Exclusive Distribution Deal with Responsive Arthroscopy
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Johnson & Johnson (J&J, NYSE: JNJ) MedTech, a leading player in the US medical technology sector, has announced an exclusive commercial distribution agreement with Responsive Arthroscopy Inc., an innovative medical device company specializing in sports soft tissue repair solutions. This strategic partnership is aimed at bolstering J&J MedTech’s sports medicine…
Jiangsu Hengrui Receives NMPA Approval for SHR-2173 Clinical Trial in ITP
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its investigational biologic product, SHR-2173, in patients with primary immune thrombocytopenia (ITP). This development marks a significant step forward in expanding treatment options…
Eisai and Biogen’s Lecanemab Receives Positive CHMP Opinion for Early Alzheimer’s Treatment
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Eisai Co., Ltd (TYO: 4523) and Biogen Inc. (NASDAQ: BIIB) have jointly announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of lecanemab, an amyloid-beta (Aβ) monoclonal antibody, for the treatment of adult patients…
BeiGene Ltd to Become BeOne Medicines Ltd, Emphasizing Global Oncology Commitment
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China-based biotechnology company BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced a proposed change of its English name to BeOne Medicines Ltd. This rebranding underscores the company’s dedication to developing innovative medicines aimed at eliminating cancer and its intention to partner with the global community to serve a…
Beijing Biostar Partners with Baheal for Utidelone Market Promotion in China
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Beijing Biostar Technologies Ltd (HKG: 2563), a synthetic biology-driven anti-tumor drug specialist that made its debut in Hong Kong last month, has entered into a market promotion service agreement with Baheal Pharmaceutical Group (SHE: 301015), a leading health services and distribution company in China. This collaboration will see Baheal provide…
Sino Biopharmaceutical’s TQB3002 Receives FDA Clearance for Phase I Study
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Sino Biopharmaceutical Ltd (HKG: 1177), a leading China-based pharmaceutical company, has announced that it has received clearance from the US Food and Drug Administration (FDA) to initiate a Phase I clinical study for its TQB3002. This is an in-house developed fourth-generation epidermal growth factor receptor (EGFR) inhibitor, marking a significant…
PegBio Files for IPO on Hong Kong Stock Exchange
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PegBio Co., Ltd., a specialist in endocrine metabolism based in Suzhou, has taken a significant step towards going public with an initial public offering (IPO) filing to the Hong Kong Stock Exchange (HKSE). While the price and other specific details of the offering are yet to be disclosed, the move…
Mabwell Bioscience Receives NMPA Approval for 9MW2821 Clinical Trials
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a China-based biopharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate clinical studies for its antibody drug conjugate (ADC), 9MW2821. This drug targets Nectin-4 and will be evaluated in combination with programmed-death 1 (PD-1)…
WuXi Biologics Expands Sterile Filling Capabilities in Germany with New Line
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China’s Contract Research, Development, and Manufacturing Organization (CRDMO) WuXi Biologics (HKG: 2269) has announced plans to establish a new sterile filling line for prefilled syringes (PFS) at its facility in Leverkusen, Germany. This move is set to enhance the company’s drug product (DP) capabilities in the region, optimizing the facility’s…
Jiangxi Jemincare’s JMX-2002 Liposome Injection Gets NMPA Clinical Clearance
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Jiangxi Jemincare Group, a China-based pharmaceutical company, has announced that it has received clinical clearance from the National Medical Products Administration (NMPA) for its JMX-2002 liposome injection. This innovative drug, known for its high efficiency and safety, is now set to commence clinical studies focusing on solid tumors, including non-small…
Lion TCR Gains NMPA Approval for mRNA TCR-T Therapy GZL-016 in HCC
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Singapore-based clinical-stage biotechnology company Lion TCR, supported by Chinese investors, has secured tacit clinical approval from the National Medical Products Administration (NMPA) for its innovative therapy GZL-016. This approval marks a significant milestone in the development of mRNA T-cell receptor engineered T-cells (TCR-T) therapy aimed at treating hepatitis B virus-associated…
