Biotechnology

NMPA Approves the NDA for CARsgen's BCMA CAR-T Therapy Zevorcabtagene Autoleucel for Relapsed or Refractory Multiple Myeloma

SHANGHAI, March 1, 2024 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announces that today the National Medical Products Administration ("NMPA") ofChi...

2024-03-01 21:50 1719

PharmAust announces positive Phase 1 MEND Study Top-Line Results in MND / ALS

Highlights: * Monepantel displays a superior safety, tolerability to the leading FDA approved drug Relyvrio® * Preliminary efficacy data shows a 58% reduction in the rate of disease progression for Cohort 2 (High Dose) using the FDA primary efficacy endpoint, ALSFRS-R * Confirmation that m...

2024-02-28 20:47 1316

FDA Grants Fast Track Designation to 9MW2821

SHANGHAI, Feb. 27, 2024 /PRNewswire/ -- Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announces that its self-developed novel ADC drug targeting Nectin-4 (R&D Code: 9MW2821) has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administ...

2024-02-27 22:00 892

111 Announces Receipt of Withdrawal of Going Private Proposal

SHANGHAI, Feb. 27, 2024 /PRNewswire/ -- 111, Inc. ("111" or the "Company") (NASDAQ: YI), a leading tech-enabled healthcare platform company committed to digitally connecting patients with medicine and healthcare services inChina, today announced that it has received a notice dated Feburary 27, 20...

2024-02-27 21:58 2345

Origin Agritech Announces Breakthrough in Corn Hybrid Development with Wild Corn Gene Integration

BEIJING, Feb. 27, 2024 /PRNewswire/ -- Origin Agritech Ltd. (NASDAQ: SEED) (the "Company" or "Origin"), a leading Chinese agricultural technology company, today announced a breakthrough development in its commercial corn hybrid offerings. Origin Agritech has successfully integrated a gene from wi...

2024-02-27 21:30 986

Nona Biosciences Enters into Collaboration Agreement with Boostimmune in Antibody-Drug Conjugate Development

CAMBRIDGE, Mass., Feb. 26, 2024 /PRNewswire/ -- Nona Biosciences, a wholly-owned subsidiary of HBM Holdings Limited committed to cutting-edge technology innovations and providing a total solution from "Idea to IND" ("I to ITM"), announced today that it has entered into a collaboration agreement w...

2024-02-27 09:23 1067

BioCity Announces Enrollment Completion of the IgA Nephropathy (IgAN) Cohort in the Randomized, Placebo-controlled Phase II Clinical Trial of the ETA Receptor Antagonist SC0062

WUXI, China, Feb. 25, 2024 /PRNewswire/ -- BioCity Biopharma is pleased to announce the completion of enrollment of all 120 participants in the IgA nephropathy (IgAN) cohort in a randomized, double-blind, placebo-controlled Phase 2 clinical study of the novel, oral endothelin A (ETA)-receptor sel...

2024-02-26 22:38 1034

GC Cell and BioCentriq® Execute Process Transfer Agreement in Anticipation of the U.S. entry of Immuncell-LC Inj.

* Immuncell-LC Inj. is an autologous Cytokine Induced Killer (CIK) cell therapy approved for Commercial use inSouth Korea as an adjuvant cell therapy for the treatment of Hepatocellular Carcinoma (HCC) after curative resection and has receivedFDA Orphan Drug Designations (ODDs) for liver, brain...

2024-02-26 21:30 1046

TransThera initiates IND-Enabling studies for TT-02332, a novel, highly potent and CNS-penetrating NLRP3 inhibitor

NANJING, China and GAITHURSBURG, Md., Feb. 26, 2024 /PRNewswire/ -- TransThera, a clinical-stage biopharmaceutical company dedicated to innovating differentiated drugs globally, today announced the initiation of IND-enabling studies for TT-02332, a potent, selective and highly CNS-penetrating NLR...

2024-02-26 21:00 923

Aucta Pharmaceuticals, Inc. ("Aucta Pharmaceuticals") launches MOTPOLY XR™ (lacosamide) extended-release capsules C-V, the first, and only once-daily formulation of lacosamide

PISCATAWAY, N.J., Feb. 26, 2024 /PRNewswire/ -- Aucta Pharmaceuticals, Inc., a private specialty pharmaceutical company focused on niche generic and branded specialty products, today announced the commercial launch of MOTPOLY XR (lacosamide) extended-release capsules C-V (100, 150 and 200 mg).  M...

2024-02-26 21:00 920

J INTS BIO, Phase 1/2 study of 'JIN-A02', a Novel Oral 4th Generation EGFR TKI, accepted for presentation at the upcoming American Association for Cancer Research 2024 meeting in USA (AACR 2024)

SEOUL, South Korea, Feb. 26, 2024 /PRNewswire/ -- J INTS BIO announced on the 26th of month that the Phase 1/2 clinical study of its Novel Oral 4th Generation EGFR TKI "JIN-A02" for the treatment of NSCLC has been accepted for poster presentation at the upcoming American Association for Cancer Re...

2024-02-26 16:15 1021

Oscotec/ADEL Initiates First-in-Human Dosing in Ph1 of Anti-MTBR Tau Antibody ADEL-Y01 In Alzheimer's Disease

PANGYO, South Korea, Feb. 23, 2024 /PRNewswire/ -- Oscotec Inc. and ADEL Inc. announced the dosing of the first healthy participant in its first-in-human study of ADEL-Y01 for the treatment of Alzheimer's disease (AD). Oscotec and ADEL are jointly developing a novel disease-modifying immunothera...

2024-02-23 21:00 1771

Immunofoco Announces the Dual Approval of IND Applications by the U.S. FDA and China CDE for the First EpCAM CAR-T Targeted at Advanced Solid Tumors

- The first EpCAM targeted CAR-T product obtained US/CN IND approval. - Acceptable safety profiles and preliminary efficacy were observed in Investigator-Initiated Trial (IIT) clinical studies of IMC001. SHANGHAI, Feb. 22, 2024 /PRNewswire/ -- Immunofoco, a company dedicated to developing cell ...

2024-02-23 12:51 1074

CATUG and Crystal Bio Establish Strategic Partnership, Launching "CATUG-Crystal" Joint Lab Dedicated to Advanced Nucleic Acid Analytical Services

CAMBRIDGE, Mass. and CRANBURY, N.J., Feb. 22, 2024 /PRNewswire/ -- CATUG Inc. (CATUG) andCrystal Bio, a member of Crystal Pharmatech, announced today a long-term strategic partnership to provide advanced nucleic acid-based drug analytical services. CATUG, a distinguished global entity specializin...

2024-02-22 21:00 1191

Mabwell Publishes the Phase III Study Results on Its Denosumab Biosimilar (MW032) in the journal JAMA Oncology

SHANGHAI, Feb. 21, 2024 /PRNewswire/ -- Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, recently published the phase III study results of denosumab biosimilar (MW032) online in the international top journal of JAMA Oncology. This is the first recorded tria...

2024-02-21 22:00 1298

WuXi Biologics Recognized as Both Industry and Regional ESG Top-Rated Company by Morningstar Sustainalytics

* Named Top-Rated for fourth consecutive year * Committed to generating long-term value for all stakeholders SHANGHAI, Feb. 21, 2024 /PRNewswire/ -- WuXi Biologics ("WuXi Bio") (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), announced it has ...

2024-02-21 18:00 2573

Hox Therapeutics and Vernalis announce a drug discovery collaboration in oncology

CHENGDU, China, Feb. 20, 2024 /PRNewswire/ -- Hox Therapeutics Ltd ("Hox") a private biotechnology company developing highly targeted cancer therapies and Vernalis (R&D) Ltd ("Vernalis"), a fully owned subsidiary of HitGen Inc., are pleased to announce a collaboration to identify inhibitors again...

2024-02-20 22:30 1348

Mabwell Receives IND Approval from FDA for Novel B7-H3 ADC 7MW3711

SHANGHAI, Feb. 20, 2024 /PRNewswire/ -- Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced that its clinical trial application of B7-H3 targeting ADC (R&D code: 7MW3711) for advanced malignant solid tumor was approved by the U.S. Food and Drug Admi...

2024-02-20 22:00 1188

FDA Grants Orphan Drug Designation to 9MW3011

SHANGHAI, Feb. 20, 2024 /PRNewswire/ -- Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced that FDA has granted Orphan Drug Designation (ODD) to 9MW3011 (R&D code in the US: MWTX-003/DISC-3405) for the treatment of patients with polycythemia vera (P...

2024-02-20 22:00 1191

WuXi Advanced Therapies Receives FDA Approval to Manufacture Iovance's AMTAGVI™ (lifileucel) for Advanced Melanoma

AMTAGVI is the first and only one-time, individualized T cell therapy to receive U.S. FDA approval fora solid tumor cancer. PHILADELPHIA, Feb. 20, 2024 /PRNewswire/ -- WuXi Advanced Therapies (WuXi ATU), a wholly owned subsidiary of WuXi AppTec, today announced that the U.S. Food and Drug Admini...

2024-02-20 21:00 2786
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