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Jiangxi Fushine’s Subsidiary LinkChem Eyes Hong Kong IPO Amid Strong Revenue Growth
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Jiangxi Fushine Pharmaceutical Co., Ltd. (SHE: 300497), a Chinese pharmaceutical company, has announced that its subsidiary, LinkChem, intends to conduct an initial public offering (IPO) on the Hong Kong Stock Exchange. At this stage, no further details regarding the IPO have been disclosed. Established in 2011 and headquartered in Shanghai,…
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AbbVie’s Telisotuzumab Vedotin Earns Breakthrough Therapy Designation in China for c-Met Positive NSCLC
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AbbVie Inc. (NYSE: ABBV), a leading pharmaceutical company based in the U.S., has announced that its cutting-edge antibody-drug conjugate (ADC) telisotuzumab vedotin has been granted breakthrough therapy designation (BTD) in China. This designation is for the treatment of advanced or metastatic epidermal growth factor receptor (EGFR) wild-type (WT) non-squamous (NSq)…
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Qilu Pharmaceutical’s Generic Pomalidomide Wins NMPA Nod for Multiple Myeloma Treatment
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Qilu Pharmaceutical, a leading pharmaceutical company based in China, has received approval from the National Medical Products Administration (NMPA) for its generic version of Celgene’s pomalidomide, expanding treatment options for multiple myeloma patients in China. This drug, a derivative of the immunomodulator thalidomide, is recognized for its anti-tumor efficacy. It…
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Fosun Pharma’s FCN-159 Receives Priority Review Status from NMPA for Pediatric Neurofibromatosis
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that the National Medical Products Administration (NMPA) has accepted for review its market approval filing for the novel small-molecule drug candidate FCN-159, granting it priority review status. The filing seeks approval for the treatment of plexiform neurofibroma (PN)…
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Luye Pharma Submits Market Approval Application for Rivastigmine Patch in Japan
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Luye Pharma Group (HKG: 2186), a leading pharmaceutical company based in China, has announced a market approval filing with the Japanese regulatory authorities for its rivastigmine twice-weekly transdermal patch, LY03013. The company is seeking marketing authorization for the drug to treat symptoms of mild-to-moderate Alzheimer’s disease (AD). Developed on Luye’s…
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HutchMed Initiates Phase I Clinical Trial for HMPL-506 in Hematologic Malignancies
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HutchMed (HKG: 0013, NASDAQ: HCM) has announced the commencement of a Phase I clinical study for its investigational compound HMPL-506 in China, with the first patient having already been dosed. The molecule is being evaluated as a potential treatment for various hematologic malignancies. This multi-center, open-label Phase I study is…
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Sino Biopharmaceutical Presents FS222 Phase I Results at ASCO Annual Meeting
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Sino Biopharmaceutical Ltd (HKG: 1177), a prominent biopharmaceutical company in China, has presented updates from a Phase I clinical trial for its tetravalent bispecific antibody (BsAb), FS222, at the American Society of Clinical Oncology (ASCO) annual meeting. The study focuses on the use of FS222 in treating advanced solid tumors…
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Jiangsu Hengrui’s HER2 Targeted ADC SHR-A1811 Poised to Earn Breakthrough Designation in China
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that its HER2 targeted antibody-drug conjugate (ADC), SHR-A1811, is on track to receive breakthrough therapy designation (BTD) status from the Center for Drug Evaluation (CDE) in China. This designation is for the treatment of HER2…
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J&J’s Tecvayli Shows Promising Response Rates in Multiple Myeloma Trial
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Johnson & Johnson (J&J; NYSE: JNJ) has reported updates from a Phase I/II clinical trial for its bispecific antibody (BsAb) Tecvayli (teclistamab) in patients with relapsed or refractory multiple myeloma (r/rMM) who have received three or more prior lines of treatment. With a median follow-up of 30.4 months, the trial…
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Bristol Myers Squibb’s Breyanzi Shows Promising Results in Three Lymphoma Trials
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Bristol Myers Squibb (BMS; NYSE: BMY) has announced results from three distinct clinical trials assessing the efficacy of its CAR-T therapy Breyanzi (lisocabtagene maraleucel) in treating patients with relapsed or refractory large B-cell lymphoma (LBCL), mantle cell lymphoma (MCL), and relapsed or refractory follicular lymphoma (FL). In a placebo-controlled, late-stage…
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AbelZeta and AstraZeneca’s C-CAR031 Shows Promising Results in HCC Treatment
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AbelZeta, a Sino-US biotech company with operations in Rockville, Maryland, and Shanghai, has presented data for its armored autologous GPC3-targeted chimeric antigen receptor (CAR) T cell therapy candidate, C-CAR031, at the American Society of Clinical Oncology (ASCO) annual meeting. The CAR-T therapy, co-developed with AstraZeneca (NASDAQ: AZN), is currently in…
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InnoCare’s Tafasitamab-Lenalidomide Combo on Track for Priority Review in China for DLBCL Treatment
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The Center for Drug Evaluation (CDE) website has indicated that InnoCare (HKG: 9969; SHA: 688428), a biopharmaceutical company based in China, is on track to receive priority review status for its drug candidate Minjuvi (tafasitamab) in combination with lenalidomide. This treatment is intended for adult patients with recurrent or refractory…
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Jiangsu Hengrui Receives NMPA Approval to Begin Clinical Trials for New Anticancer Biologic
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its investigational SHR-4849 injection. The therapy is intended for the treatment of advanced malignant solid tumors. The biologic preparation,…
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AIM Vaccine Submits Pre-IND Applications for mRNA Vaccines Targeting RSV and Herpes Zoster to NMPA
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AIM Vaccine Co., Ltd (HKG: 6660), a biopharmaceutical company based in China, has announced the submission of pre-Investigational New Drug (pre-IND) filings to China’s National Medical Products Administration (NMPA) for two of its mRNA vaccine candidates. These candidates target the respiratory syncytial virus (RSV) and herpes zoster, respectively. RSV infection…
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Olymvax Bio Receives Ethical Approval for Oral Helicobacter pylori Vaccine Trial in Australia
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Olymvax Biopharmaceuticals Inc. (SHA: 688319), a leading vaccine specialist headquartered in Chengdu, China, has announced that it has received ethical approval for a Phase I study for its oral recombinant Helicobacter pylori (HP) vaccine (Escherichia coli) in Australia. The company has completed the clinical trial filing for this proprietary product.…
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Sanofi Receives NMPA Approval for Phase III Clinical Trial of RSV Vaccine SP0125
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Sanofi (EPA: SAN), a major French multinational pharmaceutical company, has announced that it has received clinical trial approval from China’s National Medical Products Administration (NMPA) for SP0125, a nasal spray respiratory syncytial virus (RSV) attenuated live vaccine intended for use in infants and young children. RSV is among the most…
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Huadong Medicine’s ROR1-Targeting ADC HDM2005 Cleared for Clinical Trials by China’s NMPA
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Huadong Medicine Co., Ltd (SHE: 000963), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with clinical trials for HDM2005, an antibody-drug conjugate (ADC) that targets the recombinant receptor tyrosine kinase-like orphan receptor 1 (ROR1). The molecule…
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Gilead and Arcus Biosciences Report Positive Combination Therapy Results in mCRC Trial
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Biopharmaceutical companies Gilead (NASDAQ: GILD) and Arcus Biosciences (NYSE: RCUS) have announced safety and efficacy data from a Phase Ib/II clinical trial for a combination therapy in third-line metastatic colorectal cancer (mCRC). The trial evaluated the combination of adenosine receptor antagonist etrumadenant, anti-PD-1 drug zimberelimab, VEGF inhibitor bevacizumab, and chemotherapy…
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AstraZeneca’s Tagrisso Achieves Milestone Progression-Free Survival in Late-Stage Lung Cancer Study
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AstraZeneca (AZ; NASDAQ: AZN), a UK-based pharmaceutical and biopharmaceutical company, has announced preliminary results from a late-stage study for its EGFR inhibitor, Tagrisso (osimertinib), in patients with unresectable, stage III EGFR-mutated non-small cell lung cancer (NSCLC) characterized by exon 19 deletions or exon 21 mutations. The trial successfully met its…
