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China-based Connect Biopharmaceuticals Ltd has announced the topline results of a pivotal clinical study for its monoclonal antibody (mAb) candidate, CBP-201, targeting allergic inflammation in moderate-to-severe atopic dermatitis (AD). The study was conducted across multiple centers in China and evaluated the efficacy and safety of CBP-201, as well as the…
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Kira Pharmaceuticals, a Sino-US biotech company, has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase II clinical study of KP104. The study will assess the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of KP104 in participants with systemic lupus…
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BGI Genomics Co., Ltd, a leading Chinese gene sequencing firm, has reportedly been added to the US Defense Department’s list of Chinese companies subject to an investment ban for Americans. The move follows the company’s collaboration with China’s military to develop prenatal tests, as noted by Reuters. Background and ImplicationsThe…
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China-based Humanwell Healthcare (Group) Co., Ltd (SHA: 600079) has announced that it has received another indication approval from the National Medical Products Administration (NMPA) for its remimazolam (benzenesulfonate), a Category 1 chemical injectable. The drug is now approved for use as a sedative in support of bronchoscopy procedures. Drug Overview…
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Biosyngen has announced that its investigational new drug (IND) filing for the first-in-class (FIC) drug candidate BRG01 has been accepted for review by the Center for Drug Evaluation (CDE). This marks a significant milestone in the development of BRG01, an innovative therapy for the treatment of relapsed/metastatic nasopharyngeal cancer (NPC).…
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Chinese biopharmaceutical firm Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) has released its 2022 interim report, indicating significant year-on-year (YOY) revenue growth. The company reported revenues of $94.9 million, up 66.37% YOY, driven by strong product sales, which increased 64.22% YOY to $93.67 million. Product Sales PerformanceThe main drivers of…
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Suzhou-based biotech Alphamab Oncology (HKG: 9966) has announced that its China-based Phase II KN019-201 study, assessing the safety and efficacy of its cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) immunosuppressive fusion protein KN019 in active rheumatoid arthritis (RA) patients with inadequate response to methotrexate (MTX), has reached its primary endpoint. Study Design…
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China-based Contract Research, Development, and Manufacturing Organization (CRDMO) WuXi Biologics (HKG: 2269) has entered into a long-term partnership with compatriot firm neoX Biotech, an artificial intelligence (AI) empowered company. The collaboration will focus on the process development and large-scale manufacturing of neoX’s in-house developed macromolecule drugs. Financial details of the…
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China-based Luye Pharma Group (HKG: 2186) has announced that its controlling subsidiary, Shandong Boan Biotechnology Co., Ltd, has entered into a partnership with compatriot firm Shanghai Pharmaceutical Group (Benxi) North Pharmaceutical Co., Ltd. The collaboration will focus on the manufacturing of biologic drugs. Financial details of the partnership were not…
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Staidson (Beijing) Pharmaceutical Co., Ltd (SHE: 300204), a China-based pharmaceutical company, has announced that it has received another clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 biologic, STSP-0601. The approval is for the on-demand treatment of bleeding in patients with hemophilia A or B…
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Shanghai Henlius Biotech (HKG: 2696) has announced that it has received approval from the US Food and Drug Administration (FDA) to initiate a clinical study for its epidermal growth factor receptor (EGFR)-targeted monoclonal antibody (mAb), HLX07, in patients with locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC). This marks…
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Suzhou Novoprotein Scientific Co., Ltd, a China-based provider of protein technology and application solutions, has successfully completed its initial public offering (IPO) on the Shanghai Stock Exchange’s Sci-Tech Innovation Board (STAR). The net proceeds from the IPO will be used to advance the company’s capabilities in diagnostics raw materials and…
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China-based Rainmed Medical Limited has announced that it has received market approval from Australia’s Therapeutic Goods Administration (TGA) for its in-house developed coronary angiography-based fractional flow reserve system (caFFR System). The approval marks another significant milestone for the company in expanding its global footprint. Product Overview and BenefitsThe caFFR System…
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NeuShen Therapeutics has announced the successful closure of a $20 million Series pre-A financing round led by Lapam Capital. The proceeds will be used to advance the company’s central nervous system (CNS) drug research and development platform, as well as to support the development of new drugs targeting CNS disorders.…
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) has announced that it has filed a New Drug Application (NDA) with the National Medical Products Administration (NMPA) for its JAK inhibitor, jacktinib, to treat medium to high risk myelofibrosis (MF). This includes primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (Post PV MF), and…
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China-based Innovent Biologics, Inc. (HKG: 1801) has released its 2022 interim report, recording RMB 2.24 billion ($311.2 million) in revenue during the first half of this year, up 15.3% year-on-year (YOY). Product sales increased 10% YOY to RMB 2.04 billion ($283.4 million), driven by Tyvyt (sintilimab), a programmed death-1 (PD-1)…
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China-based Lepu Biotechnology Co., Ltd (HKG: 2157) has announced that it has received Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation for its core product MRG003 in recurrent/metastatic nasopharyngeal carcinoma (R/M NPC). The epidermal growth factor receptor (EGFR) targeted antibody drug conjugate (ADC) had previously obtained Orphan Drug…
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China-based Lepu Biotechnology Co., Ltd (HKG: 2157) has announced that it has received another indication approval from the National Medical Products Administration (NMPA) for its HX008, a programmed death 1 (PD-1) targeted humanized IgG4 monoclonal antibody (mAb). The drug, which was first approved in China in July this year for…
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China-based gene therapy specialist Neurophth Biotechnology Ltd has announced that the first patient has been dosed in a Phase III clinical study for its NR082 (rAAV2-ND4, NFS-01). The study is being conducted in China to evaluate the efficacy and safety of NR082, a recombinant adeno-associated virus serotype 2 (rAAV2), in…
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Guangzhou-based Bio-Thera Solutions (SHA: 688177) has announced the completion of all dosage groups (from 100 mg to 1500 mg) in a Phase I clinical study for its BAT2022. The results of the study demonstrated good safety across all dosage groups. BAT2022: Drug OverviewBAT2022 is a bispecific neutralizing antibody against COVID-19…