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NMPA Approves Synaptic Medical’s Cryoablation Device and Gene Methylation Detection Kit
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China’s National Medical Products Administration (NMPA) has granted marketing approval for two new medical devices: Synaptic Medical’s cryoablation device and Wuhan Kadwise Biotechnology Co., Ltd’s human CDO1/AJAP1/GALR1 gene methylation detection kit (fluorescence PCR method). These approvals highlight advancements in treating atrial fibrillation and diagnosing endometrial cancer. Cryoablation Device for Atrial…
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Huadong Medicine’s MediBeacon TGFR System Receives FDA Marketing Clearance
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced receiving marketing clearance from the US Food and Drug Administration (FDA) for its MediBeacon Transdermal GFR System (TGFR), a medical device co-developed with US partner MediBeacon Inc. The system is designed to evaluate renal function in adult patients with both impaired…
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MediLink’s YL201 Receives Breakthrough Therapy Designation for Nasopharyngeal Carcinoma
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Suzhou-based biotech MediLink Therapeutics (Suzhou) Co., Ltd has announced receiving another breakthrough therapy designation (BTD) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for its antibody drug conjugate (ADC) YL201. The designation is for the treatment of recurrent/metastatic nasopharyngeal carcinoma (R/M NPC), following the…
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Jiangsu Lianhuan Completes Enrollment for Phase III Study of LH-1801 in Type 2 Diabetes
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China-based Jiangsu Lianhuan Pharmaceutical Co., Ltd (SHA: 600513) has announced the completion of subject enrollment for the Phase III clinical study of its Category 1 drug LH-1801, in combination with metformin. The study aims to evaluate the efficacy and safety of LH-1801 in treating type 2 diabetes, building on its…
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Arrowhead’s Plozasiran Accepted for FDA Review in Familial Chylomicronemia Syndrome
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US-based Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) has announced that the New Drug Application (NDA) for its plozasiran, targeting familial chylomicronemia syndrome (FCS), has been accepted for review by the US Food and Drug Administration (FDA). The Prescription Drug User Fee Act (PDUFA) target date for the review is set for…
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Keymed and InnoCare Announce Licensing Deal for CD20xCD3 Bispecific Antibody with Prolium
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China-based Keymed Biosciences Inc. (HKG: 2162) and InnoCare Pharma (HKG: 9969, SHA: 688428) have jointly announced a licensing agreement with Prolium, a US-based biotech backed by RTW Investments. Under the terms of the agreement, Prolium will obtain development, regulatory filing, manufacturing, and commercialization rights to ICP-B02 (CM355), a CD20xCD3 bispecific…
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GSK’s Jemperli Approved for First-Line Endometrial Cancer Treatment in EU
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UK-based GSK plc (NYSE: GSK, LON: GSK) has announced receiving approval from the European Commission for a new indication for its PD-1-blocking antibody Jemperli (dostarlimab). The drug is now approved for use in combination with chemotherapy (carboplatin and paclitaxel) as a first-line treatment for adult patients with primary advanced or…
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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.…
