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Boehringer Ingelheim Wins Patent Infringement Ruling Against HEC Over Trajenta
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The China National Intellectual Property Administration (CNIPA) has ruled in favor of German pharmaceutical giant Boehringer Ingelheim (BI) in a patent infringement dispute with HEC and its affiliate Yichang HEC Changjiang Pharmaceutical Co., Ltd. The ruling centers on BI’s patent protecting the linagliptin compound used in its Trajenta diabetes drug.…
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Zelgen’s Jacktinib Hits Phase IIb Endpoint in Myelofibrosis Study
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) announced the successful completion of a pivotal Phase IIb clinical trial (ZGJAK006) for its in-house Janus kinase (JAK) inhibitor, jacktinib, in patients with ruxolitinib-intolerant, medium- to high-risk myelofibrosis. The study met its primary endpoint, with 43.2% of subjects achieving ≥35% spleen volume reduction…
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Ascletis Pharma’s ASC10 Receives IND Approval for COVID-19 Treatment in US and China
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China-based Ascletis Pharma Inc. (HKG: 1672) has provided updates on the clinical progress of ASC10, its oral RNA-dependent RNA polymerase (RdRp) drug therapy for COVID-19. The National Medical Products Administration (NMPA) has accepted an Investigational New Drug (IND) filing for review, and the US Food and Drug Administration (FDA) has…
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ProfoundBio Receives FDA Approval for PRO1184, Appoints New CMO
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China-based macromolecular targeted therapy developer ProfoundBio (Suzhou) Co., Ltd announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its antibody drug conjugate (ADC) PRO1184 in advanced tumors. The announcement was made alongside the appointment of Dr. Naomi Hunder as the company’s chief…
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Lee’s Pharma Completes Enrollment for NVK-002 Myopia Trials in China
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Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) subsidiary Zhaoke Ophthalmology Ltd (HKG: 6622) announced the completion of patient enrollment in two Phase III trials for NVK-002, its core product for controlling myopia progression in children and adolescents. The studies, known as China CHAMP and Small CHAMP, mark a key milestone in…
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Lynk Pharma Gets NMPA Green Light for LNK01004 Atopic Dermatitis Study
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Hangzhou-based Lynk Pharmaceuticals Co., Ltd announced it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study of its drug LNK01004 for atopic dermatitis (AD). The drug was previously approved for a clinical trial in mild to moderate plaque psoriasis, with the first patient dosed…
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Sciwind Biosciences’ XW003 Hits Phase II Trial Goals in Type 2 Diabetes Treatment
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Hangzhou-based biopharma Sciwind Biosciences Co., Ltd announced positive results from a 20-week Phase II trial of its XW003 (ecnoglutide) in Chinese adults with type 2 diabetes (T2D). The study demonstrated the drug’s safety, tolerability, and significant HbA1c reductions, meeting primary endpoints. Study DetailsThe multi-center, randomized, placebo-controlled trial involved 145 patients…
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Eli Lilly Files for Baqsimi Approval in China to Treat Severe Hypoglycemia
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Eli Lilly & Co. (NYSE: LLY) has submitted a market approval application to China’s Center for Drug Evaluation (CDE) for Baqsimi, its glucagon nasal powder spray designed to treat severe hypoglycemia in diabetes patients aged four and older. Drug DetailsHypoglycemia, a common complication during diabetes treatment, can be life-threatening and…
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Aosaikang’s ASKG315 Receives Ethics Approval for Phase I Cancer Trial in Australia
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Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755) announced it has received ethical approval from Australia’s Bellberry Human Research Ethics Committee (HREC) to initiate a Phase I clinical trial for ASKG315, its recombinant human interleukin-15 (IL-15) prodrug Fc fusion protein. The trial will assess the molecule in patients with advanced malignant…
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Eli Lilly’s Taltz Wins Second NMPA Approval for Ankylosing Spondylitis
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U.S. pharmaceutical giant Eli Lilly announced it has received a second marketing approval from the National Medical Products Administration (NMPA) for Taltz (ixekizumab). The IL-17A monoclonal antibody (mAb) is now approved to treat active ankylosing spondylitis (AS) in patients with a poor response to conventional therapy. Drug BackgroundTaltz was first…
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Hengrui Medicine’s Pyrotinib Combo Meets Endpoints in HER2+ Breast Cancer Trial
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) announced that its tyrosine kinase inhibitor (TKI) pyrotinib, combined with trastuzumab and docetaxel, met endpoints in a Phase III clinical trial as a first-line treatment for HER2-positive recurrent/metastatic breast cancer. The company plans to hold pre-market approval filing discussions with regulators soon. Study…
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Shouyao Holdings Receives Approval for CT-3505 ALK Inhibitor Study in NSCLC
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Beijing-based Shouyao Holdings (Beijing) Co., Ltd (SHA: 688197) announced it has received ethical approval from the Cancer Institute and Hospital at the Chinese Academy of Military Science to conduct a Phase I/II clinical study (CT-3505-I-01) of its CT-3505 in patients with ALK-positive non-small cell lung cancer (NSCLC). Drug ProfileCT-3505, an…
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InnoCare Pharma Doses First Patient in ICP-488 Study for Autoimmune Diseases
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China-based InnoCare Pharma (HKG: 9969) announced that the first subject has been dosed in a clinical study for ICP-488, its TYK2 JH2 allosteric inhibitor. The drug is being developed for autoimmune diseases such as psoriasis and inflammatory bowel disease (IBD). Mechanism of ActionICP-488 is a potent and selective inhibitor of…
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HutchMed Initiates China Bridging Study for Tazverik in Follicular Lymphoma
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HutchMed (NASDAQ: HCM, HKG: 0013) announced the initiation of a bridging study for Tazverik (tazemetostat) in China, with the first patient dosed on July 29, 2022. The multi-center, open-label, Phase II study (NCT05467943) will evaluate the drug’s efficacy, safety, and pharmacokinetics in relapsed/refractory follicular lymphoma (FL). Drug BackgroundTazverik, an EZH2…
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Eccogene Receives FDA Approval for ECC4703 Phase I Study in NASH and Dyslipidemia
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Shanghai-based biopharmaceutical company Eccogene announced it has received approval from the U.S. Food and Drug Administration (FDA) to initiate a Phase I clinical trial for ECC4703, a thyroid hormone receptor (THR) agonist. The study will assess the drug’s safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy participants and subjects with elevated…
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Lion TCR Enrolls First Patient in LioCyx-M004 Study for HBV-Related Liver Cancer
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Singapore-based clinical-stage biotech Lion TCR announced the enrollment of the first subject in a clinical study for LioCyx-M004, its autologous T-cell therapy targeting HBV-related hepatocellular carcinoma (HCC). The therapy uses mRNA-engineered T-cells to recognize and destroy hepatitis B virus (HBV)-related liver cancer cells. Therapy DetailsLioCyx-M004 leverages Lion TCR’s RNA technology…
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Grand Pharma’s TLX591-CDx and TLX250-CDx Advance in China with NMPA Review
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Grand Pharmaceutical Group Limited (HKG: 0512) announced that the National Medical Products Administration (NMPA) has accepted Investigational New Drug (IND) filings for TLX591-CDx (Illuccix) and TLX250-CDx, its radiopharmaceuticals for prostate cancer and clear cell renal cell carcinoma (ccRCC) diagnostics. Drug Profiles China Trials Global DevelopmentTLX591-CDx is filed for marketing in…
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Sanjin Pharma’s Subsidiary Gets FDA Nod for BC007 Cancer Drug Trial
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China-based Guilin Sanjin Pharmaceutical Co. Ltd (SHE: 002275) announced that its subsidiary, Dragon Boat Pharmaceutical (Shanghai) Co., Ltd, has received approval from the U.S. Food and Drug Administration (FDA) to conduct a Phase I clinical study of BC007, a bispecific antibody (BsAb) targeting CLDN18.2 and CD47, in patients with solid…
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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…
