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Shenzhen Salubris Pharmaceuticals’ SAL0120 for IgA Nephropathy Accepted for NMPA Review
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Shenzhen Salubris Pharmaceuticals Co., Ltd (SHE: 002294) has announced that the National Medical Products Administration (NMPA) has accepted its clinical trial filing for the small molecule SAL0120, which is indicated for the treatment of IgA nephropathy. SAL0120: An Endothelin Receptor Antagonist for Chronic Kidney Disease and HypertensionSAL0120, an in-house developed…
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Betta Pharmaceuticals’ MCLA-129 Combo Therapy for NSCLC Gets NMPA Clinical Approval
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China-based Betta Pharmaceuticals Co., Ltd (SHE: 300558) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its bispecific antibody, MCLA-129, in combination with befotertinib for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). The treatment…
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Pfizer Launches Phase III Trial for Quadrivalent Influenza modRNA Vaccine in Argentina
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Global pharmaceutical giant Pfizer (NYSE: PFE) has commenced recruitment in Argentina for a Phase III clinical trial evaluating the efficacy of its quadrivalent influenza modified RNA (modRNA) vaccine in comparison to a conventional quadrivalent influenza vaccine. This double-blind study aims to recruit between 1,500 to 2,000 participants who are above…
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Zai Lab Initiates Phase III Trial for Bemarituzumab in First-Line Gastric Cancer Treatment
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China-based biopharmaceutical company Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688) has announced the first patient dosing in the global regulatory Phase III FORTITUDE-101 trial for its drug candidate bemarituzumab, which is being studied for the treatment of first-line gastric cancer in China. Bemarituzumab’s Mechanism and Potential ImpactBemarituzumab is a potential…
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Chile Expands Financial Coverage for AbbVie’s RSV Prophylaxis Synagis
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Chile’s Ministry of Health (MINSAL) has announced an immediate expansion in the coverage under its Financial Protection System for High-Cost Diagnosis and Treatments for AbbVie’s (NYSE: ABBV) respiratory syncytial virus (RSV) prophylaxis, Synagis (palivizumab). The biologic drug is now provided free of charge to families of infants weighing under 2.5…
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Silence Therapeutics Receives $4 Million Milestone Payment from Hansoh Pharmaceutical
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UK-based Silence Therapeutics plc (NASDAQ: SLN) has announced the receipt of a $4 million milestone payment from China’s Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) as part of their ongoing collaboration. The specific details of the milestones achieved have not been disclosed, marking a confidential advancement in their joint efforts.…
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Harbour BioMed Reports First-Ever Profit in H1 2023 Interim Financial Results
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Harbour BioMed (HKG: 2142), a biotech company with operations in Suzhou, China, Cambridge in the US, and the Netherlands, has announced its interim financial results for the period ending June 30, 2023. In a preliminary review of unaudited figures, the company reported a net profit for the first time, expecting…
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InnoCare Pharma and ArriVent Biopharma Partner on SHP2 Inhibitor and EGFR Inhibitor Combination
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China-based InnoCare Pharma (HKG: 9969; SHA: 688428) has announced a clinical development collaboration with US-based ArriVent Biopharma Inc. The partnership aims to evaluate the combination of InnoCare’s novel SHP2 allosteric inhibitor, ICP-189, with ArriVent’s furmonertinib, a highly brain-penetrant and broadly active mutation-selective EGFR inhibitor. Combining ICP-189 and Furmonertinib for Solid…
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GSK’s Cabotegravir Receives NMPA Approval for HIV Treatment in China
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The National Medical Products Administration (NMPA) has granted marketing approval for GlaxoSmithKline’s (GSK, NYSE: GSK) cabotegravir, a significant development in HIV treatment options. Both the injection and tablet dosage forms of the drug have been approved for use in China. Cabotegravir: An Innovative INSTI for HIV TreatmentCabotegravir is an integrase…
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Beijing Tinavi Medical’s Knee Replacement Navigation System Approved by NMPA
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Beijing Tinavi Medical Technologies Co., Ltd (SHA: 688277) has received marketing approval from the National Medical Products Administration (NMPA) for its innovative navigation and positioning system designed for knee joint replacement surgery. This marks the 218th innovative product designation granted by China’s NMPA. Innovative 6-DOF Robotic Arm Technology in Knee…
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GeneQuantum Healthcare and Aimed Bio Expand Partnership to Develop Five Novel ADC Drugs
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China-based GeneQuantum Healthcare has unveiled a new agreement to expand its existing partnership with South Korea-based biotech firm Aimed Bio. The collaboration will see the two companies jointly develop up to five novel antibody drug conjugate (ADC) drugs, with the specific molecular and disease targets undisclosed. This expansion follows last…
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BeiGene’s Brukinsa Receives US FDA Review for Relapsed/Refractory Follicular Lymphoma sNDA
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China-based biotechnology company BeiGene (NASDAQ: BGNE) has announced that the US Food and Drug Administration (FDA) has accepted for review a new supplemental new drug application (sNDA) for its Bruton’s tyrosine kinase (BTK) inhibitor, Brukinsa (zanubrutinib). The application seeks to add a new indication for the treatment of adults with…
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AstraZeneca and Daiichi Sankyo’s Enhertu Gains New Indication Approval in China for HER2-Low Breast Cancer
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Partners AstraZeneca (AZ, NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) have announced that their co-developed antibody drug conjugate (ADC), Enhertu (trastuzumab deruxtecan), has been granted a new indication approval in China. This marks the drug’s second approval in the country and is specifically for use as a monotherapy in treating…
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US FDA Approves Additional Shipments of Qilu Pharmaceutical’s Cisplatin to Address Shortage
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The US Food and Drug Administration (FDA) is maintaining its reliance on China-based Qilu Pharmaceutical for supplies of the essential chemotherapy drug, cisplatin. Following the initial import of four lots in May, an additional ten lots have been approved this month. The drugs are distributed by Canada-based Apotex and are…
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Shanghai Fosun Pharmaceutical Submits Tenapanor Approval Application to China’s NMPA
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196), a China-based pharmaceutical company, has announced a market approval filing to the National Medical Products Administration (NMPA) in China for its in-licensed tenapanor. The drug is indicated for the control of hyperphosphatemia in adult patients with chronic kidney disease (CKD) who are…
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DNE Group Launches $485 Million Fund for Life Sciences Park in Shanghai Pudong
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China-based infrastructure investor DNE Group has revealed that it has raised a new fund worth over RMB 3.5 billion (USD 485 million) to establish a life sciences park in Shanghai’s Pudong district. The fund, which was opened in Q1 2023, is reportedly backed primarily by China-based insurance companies. The project,…
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LianBio Secures Clinical Supply Agreement with AstraZeneca for SHP2 Inhibitor Trial
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Sino-US biotech firm LianBio (OTCMKTS: LIANY) has announced the signing of a clinical supply agreement with UK pharmaceutical giant AstraZeneca (AZ, NASDAQ: AZN). The agreement facilitates LianBio’s plan to test the combination of its pipeline SHP2 inhibitor, BBP-398, with AstraZeneca’s Tagrisso (osimertinib) in a Phase I clinical trial for patients…
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Medidata Partners with ECCO and GoBroad to Transform Cancer Trials with Digital Tech
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Medidata, a wholly owned subsidiary of France firm Dassault Systèmes (EPA: DSY), has announced a strategic partnership with the East Clinical Center of Oncology (ECCO) and GoBroad Healthcare Group. The collaboration aims to explore the digital transformation of cancer clinical trials and enhance the clinical application of Rave EDC (Electronic…
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Shanghai Circode Bio and Pfizer Collaborate to Explore Circular RNA Therapy Potential
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Shanghai Circode Bio has entered into a partnership with US pharmaceutical giant Pfizer (NYSE: PFE) to explore the therapeutic potential of circular RNA (circRNA). This strategic collaboration aims to fully leverage Circode Bio’s unique circular RNA technology platform and combine it with Pfizer’s extensive expertise and experience in the pharmaceutical…
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Kedrion Biopharma Achieves First Product Approval in China for Human Albumin
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Italy-headquartered blood products specialist Kedrion Biopharma has announced that its subsidiary, Bio Products Laboratory (BPL), has received approval from China’s National Institutes for Food and Drug Control (NIFDC) to release human albumin into the Chinese market for the first time. This milestone follows a 2022 partnership established between Kedrion and…
