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Innovent and Laekna Dose First Patient in Afuresertib and Tyvyt Study for PD-1 Resistant Tumors
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China’s Innovent Biologics Inc. (HKG: 1801) and partner Laekna Therapeutics Shanghai Co., Ltd announced that the first patient has been dosed in a Phase I/II clinical study (NCT05383482) evaluating afuresertib combined with Tyvyt (sintilimab) plus chemotherapy in solid tumors resistant to PD-1/PD-L1 inhibitors. Study DetailsThe multi-center, single-arm, open-label, dose-escalation study…
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Dongcheng Pharmaceutical Gets NMPA Green Light for PSMA PET Imaging Drug
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China-based Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675) announced it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for a radioactive in vivo diagnostic drug. The drug is intended for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA)-positive lesions in…
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CanSino Biologics Launches Menhycia Meningococcal Vaccine in Six Provinces
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China-based CanSino Biologics (HKG: 6185) announced the launch of its ACYW135 Meningococcal Conjugate Vaccine (CRM197) (MCV4, trade name: Menhycia), marking the debut of China’s first quadrivalent meningococcal conjugate vaccine. The vaccine is now available in Anhui, Shandong, Fujian, Guangxi, Heilongjiang, and Yunnan. Vaccine DetailsMenhycia covalently binds to meningococcal serogroups A,…
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Mabwell Bioscience Gets FDA Approval for Nectin-4 ADC 9MW2821 in Solid Tumors
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China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) announced it has received approval from the U.S. Food and Drug Administration (FDA) to conduct a clinical study of its antibody drug conjugate (ADC) 9MW2821, targeting Nectin-4, in solid tumors. The drug is the first of its kind to enter clinical trials…
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LaNova Medicines Gets FDA Green Light for LM-305 Myeloma Study
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Shanghai-based cancer therapy developer LaNova Medicines Ltd announced it has received approval from the U.S. Food and Drug Administration (FDA) to conduct an open-label, multi-center Phase I/II study of LM-305, an antibody drug conjugate (ADC) targeting GPRC5D, in patients with multiple myeloma (MM). Drug ProfileLM-305 is the first GPRC5D-targeting ADC…
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Sanofi’s Q2 Earnings Show 8.1% Global Sales Growth, Led by Dupixent and China Expansion
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France-based Sanofi (NASDAQ: SNY) reported Q2 2022 global sales of EUR 10.1 billion (USD 10.3 billion), marking an 8.1% year-on-year (YOY) increase in constant exchange rate (CER) terms. Growth was driven by the anti-allergy drug Dupixent (dupilumab) and strong performances in rare diseases, vaccines, and consumer healthcare. Pharmaceuticals and Vaccines…
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CSPC Pharmaceutical’s Albumin-Bound Docetaxel Receives Orphan Drug Designation for Gastric Cancer
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) announced that it has received an orphan drug designation (ODD) from the National Medical Products Administration (NMPA) for its docetaxel (albumin-bound) in gastric cancer, including esophagogastric junction cancer. Product ProfileThe product uses innovative human albumin encapsulation technology to deliver docetaxel nanoparticles into the…
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Hybio Pharmaceutical’s Liraglutide Filing Accepted by NMPA, Becomes Domestic Leader in GLP-1 Analog
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China-based Hybio Pharmaceutical Co., Ltd (SHE: 300199) announced that its market filing for liraglutide, a Category 2.2 chemical drug, has been accepted for review by the National Medical Products Administration (NMPA). Hybio is now the only domestic firm to complete clinical trials via chemical synthesis and file for marketing of…
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Roche’s Rozlytrek Wins NMPA Approval for NTRK Fusion Gene-Positive Tumors
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Swiss pharmaceutical giant Roche announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its tumor-agnostic therapy Rozlytrek (entrectinib). The drug is approved for treating solid tumors in patients aged 12 and older who carry a neurotrophic tyrosine receptor kinase (NTRK) fusion gene and have…
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Kira Pharmaceuticals’ KP104 Receives Orphan Drug Designation for PNH Treatment
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Sino-US biotech Kira Pharmaceuticals announced that it has received an Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for KP104, its first-in-class biologic for the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH). Drug ProfileKP104 is a bifunctional biologic designed to selectively block the alternative and terminal pathways…
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Shenzhen Unveils Measures to Boost Biomedical and Medical Device Industries
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Shenzhen’s municipal Development and Reform Commission has released a series of measures to promote the development of the city’s biomedical, medical device, and big health industry clusters. The initiatives aim to accelerate infrastructure construction, enhance clinical research capabilities, and streamline drug registration and approval processes. Infrastructure and Research Support Funding…
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Merck’s Q2 Sales Surge 31% to USD 14.6B, Led by Keytruda and China Growth
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US-based Merck, Sharp & Dohme (MSD, NYSE: MRK) reported Q2 2022 global sales of USD 14.6 billion, marking a 31% increase in constant exchange rate (CER) terms. The growth was driven by recovery from COVID-19 disruptions and contributions from the COVID-19 antiviral drug Lagevrio (molnupiravir). Key Growth Drivers China PerformanceChina…
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Takeda’s Alunbrig Prescribed in China for ALK+ NSCLC Treatment
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Japan-based Takeda Pharmaceutical Co., Ltd (TYO: 4502) announced that its lung cancer therapy Alunbrig (brigatinib) has been prescribed in China for the first time, marking its official commercialization and clinical application in the country. The drug was approved in March 2023 to treat anaplastic lymphoma kinase (ALK)-positive locally advanced or…
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Cosmo Pharma’s Winlevi Cream Secures Greater China Licensing Deal with 3SBio
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Ireland-based Cosmo Pharmaceuticals NV (SWX: COPN) and China’s 3SBio Inc. (HKG: 1530) have signed a licensing agreement for Cosmo’s Winlevi (clascoterone) cream 1%, a topical therapy for acne. 3SBio will hold development and commercialization rights for Winlevi in Greater China, including mainland China, Hong Kong, Taiwan, and Macao. Deal DetailsThe…
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PerkinElmer and SCUT Launch Joint Translational Medicine Center
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US-based PerkinElmer and China’s South China University of Technology (SCUT) have officially launched their joint translational medicine center of excellence. The center, located at SCUT’s Medical College in Guangzhou, Guangdong, is equipped with advanced scientific research tools from PerkinElmer and is open to the public. Center DetailsThe laboratory features cutting-edge…
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Sun Pharma’s Bicalutamide Supply Suspended in Multiple Chinese Regions
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India-based Sun Pharma has suspended the supply of its bicalutamide to Beijing, Tianjin, Jilin, Shanghai, Fujian, Henan, Yunnan, and Tibet due to non-compliance with importing standards caused by “loss on drying.” The national alliance procurement office has designated Hisun Pharma, Zhendong Pharma, and Zhaohui Pharma as the new suppliers for…
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MabPharm’s CMAB015 Biosimilar Receives NMPA Approval for Clinical Study
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Taizhou-based monoclonal antibody (mAb) biosimilars specialist MabPharm Ltd (HKG: 2181) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study of its CMAB015, a biosimilar of Novartis’ Cosentyx (secukinumab). The study will target psoriasis and ankylosing spondylitis. Drug ProfileCosentyx was first approved…
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CSPC Jushi Biopharm’s SYSA1801 ADC Secures Licensing Deal with Elevation Oncology
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) announced that its subsidiary, CSPC Jushi Biopharmaceutical Co., Ltd, has entered into a licensing agreement with US-based Elevation Oncology Inc. (NASDAQ: ELEV). The deal grants Elevation exclusive development and commercialization rights to CSPC Jushi’s Claudin 18.2 (CLDN18.2) antibody drug conjugate (ADC) candidate SYSA1801…
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CDE Releases 61st Batch of Generic Reference Preparations, 34 New Specs Added
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The Center for Drug Evaluation (CDE) has released the 61st batch of chemical generic reference preparations, adding 34 new specifications and updating information for 36 previously published ones. Batch DetailsThe latest batch includes updates to existing specifications and introduces new ones. However, 27 specifications failed the review due to various…
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Immunochina Pharmaceuticals Secures CAR-T Production License in Beijing
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Beijing-based Immunochina Pharmaceuticals has obtained a Drug Production License for its chimeric antigen receptor (CAR) T-cell therapies, making it the first company in Beijing and one of a few nationally to receive the certification as a gene therapy firm. Approval SignificanceThe license confirms that Immunochina’s facilities comply with quality regulations,…
