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Kelun-Biotech’s Tagitanlimab Receives NMPA Clearance for Nasopharyngeal Carcinoma
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China-based Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has announced receiving another clearance from the National Medical Products Administration (NMPA) for its PD-L1 monoclonal antibody (mAb) Ketailai (tagitanlimab). The latest approval indicates the drug for first-line treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC) when combined with chemotherapy. This follows…
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Junshi Biosciences Licenses Toripalimab to LEO Pharma for EU and UK Markets
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China-based Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced a licensing agreement with Denmark-based LEO Pharma A/S, granting the dermatology specialist exclusive rights to store, distribute, promote, market, and sell its PD-1 inhibitor, toripalimab, in the European Union (EU), the European Economic Area (EEA), Switzerland, and the…
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CARsgen Therapeutics Initiates Trial for Universal CAR-T Therapy KJ-C2320 in AML
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China-based CARsgen Therapeutics Holdings Ltd (HKG: 2171) has announced the first subject dosing in an investigator-initiated trial (ITT) for its KJ-C2320, a universal chimeric antigen receptor (CAR)-T cell therapy targeting recurrent/refractory acute myeloid leukemia (R/R AML). This milestone marks a significant step forward in the development of innovative treatments for…
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Danaher Partners with Huashan Hospital to Develop Alzheimer’s Diagnostic Solutions
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US-based science and tech services giant Danaher Corporation (NYSE: DHR) has announced a partnership between its subsidiary Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. and Huashan Hospital. The collaboration aims to develop innovative solutions for the early diagnosis and differential diagnosis of Alzheimer’s disease (AD). No financial details were disclosed.…
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Chongqing Genrix’s Xeligekimab Approved for Ankylosing Spondylitis by NMPA
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China-based Chongqing Genrix Bio Pharmaceutical Co., Ltd (SHA: 688443) has announced receiving approval from the National Medical Products Administration (NMPA) for an additional indication of its in-house developed Category 1 biologic product, xeligekimab. The anti-IL-17 antibody is now approved to treat ankylosing spondylitis (radiologically positive axial spondyloarthritis), following its initial…
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Takeda to Establish China Innovation Center in Chengdu, Focusing on Digital Health
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Japan-headquartered Takeda (NYSE: TAK, TYO: 4502) has announced plans to establish the Takeda China Innovation Center (TCIC) within the Chengdu Hi-Tech Industrial Development Zone. The company has reached an agreement with the district’s management committee to develop the center, which will focus on enhancing digital innovation capabilities in China. TCIC:…
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FDA Approves AstraZeneca’s Calquence for Mantle Cell Lymphoma
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UK-based pharmaceutical major AstraZeneca (AZ, NASDAQ: AZN) last week revealed that the US Food and Drug Administration (FDA) has approved its BTK inhibitor Calquence (acalabrutinib) in combination with bendamustine and rituximab for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic…
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NAMSA to Acquire WuXi AppTec’s US Medical Device Testing Business
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US-based medical device contract research organization (CRO) NAMSA is set to acquire the medical device testing business in the US of China-based Contract Development and Manufacturing Organization (CDMO) WuXi AppTec Co., Ltd (SHA: 603259). The acquisition includes two factories located in Minnesota and Georgia. According to the agreement, for which…
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MHRA Approves Gilead’s Livdelzi for Primary Biliary Cholangitis
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The Medicines and Healthcare products Regulatory Agency (MHRA) last week signed off on US-based Gilead Sciences Inc.’s (NASDAQ: GILD) Livdelzi (seladelpar) for the treatment of primary biliary cholangitis (PBC), including pruritus. This approval marks a significant step forward in the treatment options available for patients suffering from this chronic liver…
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Junshi Biosciences Forecasts 29.71% Revenue Growth for 2024
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China-based Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has released its 2024 annual performance forecast, projecting revenues to reach RMB 1.95 billion (USD 266 million), representing a 29.71% year-on-year (YOY) increase. This forecast highlights the company’s continued growth and expansion in the biopharmaceutical sector. R&D and Net Loss…
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FDA Clears Amgen’s Lumakras and Vectibix Combo for KRAS G12C-mutated mCRC
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US-based Amgen (NASDAQ: AMGN) has announced receiving clearance from the US Food and Drug Administration (FDA) for its Lumakras (sotorasib) combined with Vectibix (panitumumab) for the treatment of adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC). This approval is for patients whose cancer has been identified through an FDA-approved…
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Luye Pharma Launches Erzofri in US Market
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China-based Luye Pharma Group (HKG: 2186) has announced the initiation of commercialization of its in-house developed Erzofri (paliperidone palmitate extended-release injectable suspension) in the United States, with the first batch of products already shipped. This marks a significant milestone in the company’s global expansion strategy. Erzofri: Long-Acting Injection for SchizophreniaErzofri…
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Novo Nordisk’s Semaglutide 7.2 mg Shows Superior Weight Loss in Phase III Study
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Denmark-based Novo Nordisk A/S (NYSE: NVO) has announced positive headline results from the Phase III STEP UP study, assessing the efficacy and safety of subcutaneous semaglutide 7.2 mg compared to semaglutide 2.4 mg and placebo. The study met its primary endpoint, demonstrating superior weight loss outcomes with the higher dose.…
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Xinzeyuan Medical Raises Series B+ Funding for Surgical Supply Chain
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Xinzeyuan Medical Technology Co., Ltd, a minimally invasive surgical supply chain platform enterprise based in Hangzhou, has reportedly raised close to RMB 100 million (USD 13.7 million) via a Series B+ financing round. This significant capital injection will support the company’s ongoing efforts to expand its product portfolio and enhance…
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Zai Lab’s KarXT NDA Accepted by NMPA for Schizophrenia Treatment
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China-based biotech Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) has announced that a New Drug Application (NDA) filing for its KarXT (xanomeline and trospium chloride) in adult schizophrenia has been accepted for review by the National Medical Products Administration (NMPA). This milestone underscores Zai Lab’s commitment to advancing innovative treatments…
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Frontier Biotechnologies Gains NMPA Approval for Albuvirtide Phase II Study
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Nanjing-based Frontier Biotechnologies Inc. has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study for its version of albuvirtide, China’s first domestically developed innovative HIV therapy. The study will assess the drug’s efficacy in addressing immune reconstitution insufficiency in HIV-1 infected patients…
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Wanbangde’s Huperzine A Receives FDA Clearance for HIE Study
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China’s Wanbangde New Building Materials Co., Ltd (SHE: 002082) has announced receiving clearance from the US Food and Drug Administration (FDA) to study its huperzine A in neonatal hypoxic-ischemic encephalopathy (HIE). This indication has earned the drug a rare pediatric disease (RPD) designation and orphan drug designation (ODD) from the…
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FDA Approves Datroway for HR+/HER2- Breast Cancer Treatment
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Datroway (datopotamab deruxtecan-dlnk, Dato-Dxd), a Trop-2-directed antibody and topoisomerase inhibitor conjugate co-developed by Japan-based Daiichi Sankyo (TYO: 4568) and UK major AstraZeneca (AZ, NASDAQ: AZN), last week received approval from the US FDA for the treatment of adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor…
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Allist Pharmaceuticals Gains NMPA Approval for Furmonertinib Clinical Study
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Shanghai-based biotech Allist Pharmaceuticals Co., Ltd has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study assessing its furmonertinib as an adjuvant therapy for stage IB-IIIB non-small cell lung cancer (NSCLC) carrying non-classical epidermal growth factor receptor (EGFR) mutations. The study will evaluate the…
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Junshi Biosciences’ Toripalimab Gains TGA Approval for Nasopharyngeal Carcinoma
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China-based Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced receiving marketing approval from the Therapeutic Goods Administration (TGA) of the Australian Government Department of Health and Aged Care for its toripalimab. The anti-PD-1 monoclonal antibody can now be used in combination with cisplatin and gemcitabine for the…
