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CDE Releases Draft Guidelines for Antibody Drug Conjugate Research and Evaluation
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The Center for Drug Evaluation (CDE) has released a draft set of “Guiding Principles for Pharmaceutical Research and Evaluation of Antibody Drug Conjugates” and is soliciting public feedback until July 21, 2023. The document primarily addresses the technical requirements during the market approval filing stage for antibody drug conjugate (ADC)…
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Jiangsu Hengrui’s Camrelizumab Earns Full Approval for Advanced Hepatocellular Carcinoma in China
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China-based Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced the transition of its programmed death-1 (PD-1) monoclonal antibody (mAb) camrelizumab from conditional approval to full approval for the treatment of advanced hepatocellular carcinoma (HCC) in patients previously treated with sorafenib or chemotherapy. Camrelizumab’s Approval History and IndicationsCamrelizumab, which received first approval…
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Biocytogen Pharmaceuticals Receives CNIPA Patent for RenMab Human Antibody Mice Platform
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China-based Biocytogen Pharmaceuticals (Beijing) Co., Ltd (HKG: 2315) has announced receiving a prestigious patent award from the China National Intellectual Property Administration (CNIPA) for its in-house developed human antibody mice RenMab platform. This recognition underscores the company’s commitment to innovation in the field of antibody development. RenMab Technology Platform OverviewThe…
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BeiGene Initiates First-in-Human Trial for Next-Generation BCL-2 Inhibitor BGB-21447
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China-based BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced the first patient dosing in a first-in-human trial for its pipeline candidate, BGB-21447, a next-generation BCL-2 inhibitor. The trial, which is potentially superior to venetoclax based on preclinical activity, is being conducted at Shandong Hospital. Phase I Study Design and…
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Jiangsu Hengrui Pharmaceutials’ SHR-1209 for Hypercholesterolemia Accepted for NMPA Review
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China-based Jiangsu Hengrui Pharmaceutials (SHA: 600276) has announced that a market filing for its Category 1 biologic product, SHR-1209, has been accepted for review by the National Medical Products Administration (NMPA). The product is intended to treat hypercholesterolemia, a condition characterized by high levels of cholesterol in the blood. Phase…
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Minghui Pharmaceutical Achieves First Dosing Milestone in Phase I Studies for ADC Candidates
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China-based biotech Minghui Pharmaceutical Inc. has reported that the first dosing has been completed in two Phase I studies assessing the company’s antibody drug conjugate (ADC) candidate drugs, MHB036C and MHB088C. Both candidates are developed on Minghui’s proprietary SuperTopoi platform, with MHB036C targeting TROP2 and MHB088C targeting B7-H3. SuperTopoi Platform…
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CDE Considers Breakthrough Therapy Designation for Beijing Mabworks’ MIL162 and Amgen’s AMG 890
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The Center for Drug Evaluation (CDE) website indicates that China-based Beijing Mabworks Biotech Co., Ltd’s MIL162 and US firm Amgen’s AMG 890 are on track to receive breakthrough therapy designation (BTD) awards in China. MIL162 is under development as a treatment for primary membranous nephropathy (pMN), while AMG 890 targets…
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Fujian Cosunter Pharmaceutical’s COVID-19 Drug GST-HG171 Meets Primary Endpoint in Phase II/III Study
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China-based Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436) has announced that the pivotal Phase II/III regulatory clinical study for its Category 1 product, GST-HG171/ritonavir, in mild/moderate COVID-19 patients has been unblinded and has successfully reached its primary endpoint. Design and Results of the StudyThe multi-center, randomized, double-blind, placebo-controlled study aimed…
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Boehringer Ingelheim’s Spevigo on Track for Priority Review for GPP Flare Prevention in China
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Germany-based Boehringer Ingelheim’s (BI) interleukin-36 receptor (IL-36R)-targeted orphan drug, Spevigo (spesolimab), in subcutaneous injection form, is poised for priority review status in China. This recognition from the Center for Drug Evaluation (CDE) is attributed to its potential use in preventing flares in generalized pustular psoriasis (GPP), following the molecule’s earlier…
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Bio-Thera Solutions’ PD-1 Inhibitor BAT1308 Approved for Cervical Cancer Clinical Trials in China
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Bio-Thera Solutions Ltd (SHA: 688177) has announced that its programmed death-1 (PD-1) inhibitor, BAT1308, has been approved to enter clinical trials for the treatment of cervical cancer in China. The molecule will be assessed in combination with platinum chemotherapy and with or without bevacizumab, as per the Chinese firm’s announcement.…
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Sinocelltech Group Launches Biosimilar Version of AbbVie’s Humira in China
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China-based Sinocelltech Group Ltd (SHA: 688520) has officially commercialized its biosimilar version of AbbVie’s (NYSE: ABBV) Humira (adalimumab), marking a significant milestone in the Chinese biosimilar market. The company has delivered the first batch of the biosimilar product, achieving commercialization in less than two weeks following regulatory approval. Humira’s Global…
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Grand Pharmaceutical Initiates Phase II STARBURST Study for TLX250-CDx in Indication Expansion
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China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced the first patient dosing in the indication expansion Phase II STARBURST study for its TLX250-CDx (89Zr-DFO-girentuximab). The imaging agent is licensed from Australia-based Telix Pharmaceuticals Ltd (ASX: TLX) in a 2020 deal valued at up to USD 225 million. The 2020…
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Shanghai Pharmaceuticals’ SPH3127 for Hypertension Gets MNPA Review Acceptance
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China-based Shanghai Pharmaceuticals Holding Co., Ltd (SHA: 601607) has announced that the National Medical Products Administration (MNPA) has accepted a market approval filing for its SPH3127, a Category 1 drug co-developed with Japan-based Mitsubishi Tanabe Pharma Corporation. The intended indication for this novel drug is hypertension. SPH3127: A Novel Oral…
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WinHealth Pharma Receives NMPA Approval for Glycerol Phenylbutyrate for Urea Cycle Disorders
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China-based Hong Kong WinHealth Pharma Group Ltd has announced receiving market approval from the National Medical Products Administration (NMPA) for its glycerol phenylbutyrate, a drug used as a long-term treatment for patients with urea cycle disorders (UCDs). This approval specifically targets patients who cannot achieve disease control through protein intake…
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Nanjing Leads Biolabs Receives FDA IND Approval for LBL-033 Phase I/II Clinical Trial
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China-based Nanjing Leads Biolabs Co., Ltd has revealed that it has received Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) to initiate a Phase I/II clinical trial for its pipeline candidate, LBL-033. This anti-MUC16/CD3 bispecific antibody (BsAb) is set to be investigated as a potential…
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TG ImmunoPharma Receives FDA Approval for Phase I Clinical Study of TGI-6 Bispecific Antibody
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China-based TG ImmunoPharma Co., Ltd has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase I clinical study for its bispecific antibody (BsAb), TGI-6. This development marks a significant step forward in the company’s efforts to bring innovative immunotherapies to patients…
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IASO Bio Receives FDA IND Approval for IASO-782 for Autoimmune Disorders
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China-based IASO Bio has announced that the US Food and Drug Administration (FDA) has approved an Investigational New Drug (IND) filing for its pipeline candidate, IASO-782. This injectable drug candidate will be assessed in US clinical trials for the treatment of various autoimmune hematological disorders, including primary immune thrombocytopenia (ITP)…
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Aosaikang Pharmaceutical’s ASKB589 Shows Promising Results in Solid Tumor Treatment Study
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Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755) has revealed the latest results from a Phase I/II study for its Category 1 biologic product candidate ASKB589, which is being assessed as a treatment for solid tumors. The findings were presented at the 15th International Gastric Cancer Association (IGCA) meeting, highlighting the…
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Roche’s Evrysdi Receives NMPA Approval for Wider SMA Patient Age Range
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Swiss pharmaceutical giant Roche (SWX: ROG) has announced that its blockbuster nervous system drug Evrysdi (risdiplam) has received market approval from the National Medical Products Administration (NMPA) to treat spinal muscular atrophy (SMA) in patients aged 16 days and above. This marks an expansion of the drug’s indication in China,…
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MicuRx Pharmaceuticals’ MRX-4/Contezolid Combo Receives Clinical Trial Approvals for Diabetic Foot Infection
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Sino-US firm MicuRx Pharmaceuticals Inc. (SHA: 688373) has announced receiving clinical trial approvals for its novel anti-microbial agent MRX-4, combined with contezolid (MRX-I), as a sequential treatment for diabetic foot infection in Israel, Bulgaria, Slovakia, Croatia, Poland, and Brazil. In-House Developed Oxazolidinone AntibioticsBoth MRX-4 and contezolid are in-house developed new-generation…
