Pharmaceuticals
FDA Accepts GMP Plasmid DMF of OBiO Technology
SHANGHAI, Jan. 16, 2023 /PRNewswire/ -- OBiO Technology (Shanghai) Corp., Ltd. ('OBiO', 688238.SH), a gene and cell therapy-focused contract research organization (CRO) and contract development and manufacturing organization (CDMO), recently announced that the United States Food and Drug Administ...
CARsgen Therapeutics and Huadong Medicine Announce Collaboration Agreement For Zevorcabtagene Autoleucel In Mainland China
SHANGHAI, Jan. 16, 2023 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, andHuadong Medicine ( Hangzhou) Co., Ltd., a wholly-owned subsidiary of Huadong Medicine Co....
DEBIOPHARM APPLIES EXTENDED-RELEASE FORMULATION EXPERTISE TO REDUCE TREATMENT FREQUENCY BURDEN FOR ACROMEGALY & GEP-NET PATIENTS
- Acromegaly and gastroenteropancreatic neuroendocrine tumors (GEP-NETs) are rare diseases that require life-long chronic treatment. Monthly somatostatin analog (SSA) injections are the standard of care as first-line medical treatment. - Debiopharm is developing Debio 4126, a novel 3-month ext...
Samsung Biologics receives the Terra Carta Seal in recognition of the company's commitment to creating a sustainable future
* Samsung Biologics is one of 19 companies to have been awarded the 2022 Terra Carta Seal. * The Terra Carta Seal recognises global companies which are driving innovation and demonstrating their commitment to, and momentum towards, the creation of genuinely sustainable markets. * Designed b...
Dizal Announces China CDE Acceptance of New Drug Application for Sunvozertinib for Platinum-Pretreated NSCLC Patients with EGFR Exon20ins Mutations
SHANGHAI, Jan. 10, 2023 /PRNewswire/ -- Dizal (SHEX: 688192) today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for sunvozertinib for the treatment of advanced NSCLC with EGFR exon20ins...
SK Biopharmaceuticals to Present Future Plan for Global Investors, Partners at 'SK Bio Night'
SK Inc.'s 1st SK Bio Night on the sidelines of J.P. Morgan Healthcare Conference offers a glimpse into the future of its global business in new drug, CDMO, biotech SK Biopharmaceuticals joins SK Inc.'s Bio Investment Center, SK pharmteco, or 'SK bio family,'for potential investment, partnerships...
SK Inc. hosts "SK Bio Night" in San Francisco to expand global partnerships
* SK to spark innovative ideas and identify new business opportunities by presenting its global strategy and growth roadmap to over 50 partners * Newly appointed executives to lead SK's biopharmaceutical businesses to attend the event * SK Inc. to promote the competitiveness of K-bio and pro...
Alterity Therapeutics Launches ATH434 Phase 2 Clinical Trial in the United States for the Treatment of Individuals with Multiple System Atrophy
U.S. now open for enrollment of rare, rapidly progressive Parkinsonian Disorder MELBOURNE, Australia and SAN FRANCISCO, Jan. 9, 2023 /PRNewswire/ -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) ("Alterity" or "the Company"), a biotechnology company dedicated to developing disease modifying tre...
SK bioscience's Zoster Vaccine Receives Biologics License Application Approval in Malaysia
* The world-second developed shingles vaccine 'SKYZoster™' is approved by the National Pharmaceutical Regulatory Agency (NPRA) * SK biosciences plans to launch the zoster vaccine with proven efficacy and safety starting in Southeast Asian market SEOUL, South Korea, Jan. 9, 2023 /PRNewswire/ -...
Immorna Receives IND Clearance to Conduct a Phase 1 Study of JCXH-105, a Self-Replicating RNA-Based Shingles Vaccine
MORRISVILLE, N.C., Jan. 9, 2023 /PRNewswire/ -- Immorna, a rapidly expanding biotechnology company, focusing on the development of multi-platform RNA-based therapeutics and vaccines, today announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) ap...
Jacobio Completes First Patient Dosage of Aurora A Inhibitor JAB-2485 in U.S
BEIJING and SHANGHAI and BOSTON, Jan. 8, 2023 /PRNewswire/ -- Jacobio Pharma (1167.HK) announced it has completedthe first patient dosage of its in-house R&D drug candidate Aurora A Inhibitor JAB-2485 in a Phase I/IIa clinical trial for advanced solid tumour patients in U.S. JAB-2485 is a high...
Fosun Pharma and Henlius Entered into an Exclusive License Agreement for Serplulimab in the US
PRINCETON, N.J., Jan. 7, 2023 /PRNewswire/ -- Fosun Pharma (600196.SH, 02196.HK) has recently entered into an exclusive license agreement with Shanghai Henlius Biotech, Inc. (2696.HK) for the commercialisation of Henlius independently developed anti-PD-1 monoclonal antibody (mAb) serplulimab inth...
Ocedurenone (KBP-5074) Featured at ASN Kidney Week: Ocedurenone is a Potential New Treatment Option for Patients with Uncontrolled or Resistant Hypertension and Advanced CKD
Hepatic Impairment and Drug-Drug Interaction Study Results Presented PRINCETON, N.J., Jan. 6, 2023 /PRNewswire/ -- KBP Biosciences PTE. Ltd. ("KBP Biosciences" or the "Company"), a clinical-stage biotechnology company dedicated to research, development, and commercialization of innovative medici...
Alterity Therapeutics Announces 1-for-10 Reverse ADS Split (consolidation)
MELBOURNE, Australia and SAN FRANCISCO, Jan. 6, 2023 /PRNewswire/ -- Alterity Therapeutics Limited ("Alterity" or the "Company") (ASX:ATH, NASDAQ:ATHE), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today announced that its Board of D...
Double-blind period completes! Primary endpoint analysis of phase 3 clinical trial to be conducted for China's first hormone replacement treatment targeting hypoparathyroidism
Submission of NDA to the NMPA is planned within 2023 at the earliest SHANGHAI, Jan. 6, 2023 /PRNewswire/ -- VISEN Pharmaceuticals, an innovative biopharmaceutical company focused on endocrine diseases, announced today that it has completed the double-blind period of PaTHway China Trial, a phase 3...
Duality Biologics Announces License Agreement of its Next-generation ADC platform with Adcendo
* Duality to grant license of DITAC (Duality Immune Toxin Antibody Conjugates) platform to Adcendo for its lead uPARAP ADC program * Duality to receive upfront payment, development, regulatory and commercial milestones, and tiered royalties * Collaboration based on synergies between Adcendo ...
Innovent to Present at 41st Annual J.P. Morgan Healthcare Conference
ROCKVILLE, Md. and SUZHOU, China, Jan. 4, 2023 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent", "the Company") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, autoimmune, metabolic, o...
OnCusp Therapeutics Announces Appointment of Robert Forrester and Chau Khuong to Board of Directors
NEW YORK, Jan. 4, 2023 /PRNewswire/ -- OnCusp Therapeutics, a global biotechnology company with deep translational and clinical development expertise in oncology therapeutics, today announced the appointment of serial entrepreneurRobert Forrester and venture capitalist Chau Khuong as independent ...
ProfoundBio Announces Initiation of First-in-Human Trial for PRO1184, a Folate Receptor Alpha-Directed ADC with a Topoisomerase 1 Inhibitor Payload, and Receives FDA "Study May Proceed" Letter for PRO1160, a CD70-Directed ADC
* PRO1184 first-in human study initiated and first patients dosed * PRO1160 first-in-human study cleared for initiation in the US * Both PRO1184 and PRO1160 are based on a novel, proprietary, and internally developed linker-drug technology platform SUZHOU, China and WOODINVILLE, Wash., Jan. ...
Antengene to Present at the 41st Annual J.P. Morgan Healthcare Conference
SHANGHAI and HONG KONG, Jan. 3, 2023 /PRNewswire/ -- Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class therapeutics in hema...
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