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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...

2023-01-10 17:03 3160

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...

2023-01-10 07:00 2746

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...

2023-01-10 07:00 2444

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...

2023-01-09 23:25 3555

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/ -...

2023-01-09 21:00 3651

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...

2023-01-09 20:00 2533

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...

2023-01-08 14:17 4261

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...

2023-01-07 17:29 4935

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...

2023-01-06 21:00 2865

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...

2023-01-06 20:25 4945

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...

2023-01-06 18:00 2268

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 ...

2023-01-05 09:00 2099

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...

2023-01-05 00:00 3462

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 ...

2023-01-04 21:00 2659

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. ...

2023-01-03 20:00 3530

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...

2023-01-03 14:10 2903

Qilu Pharmaceutical Announces Progress of Clinical Study of QL1706, an Innovative Bifunctional Antibody

JINAN, China, Dec. 29, 2022 /PRNewswire/ -- In 2022, Qilu Pharmaceutical revealed the latest progress being made with several clinical studies involving its innovativebifunctional antibody, QL1706, at several international and Chinese academic conferences, including the American Association for C...

2022-12-29 14:32 2499

Hyphens Pharma licenses Winlevi® for all 10 ASEAN countries from Cosmo Pharmaceuticals

* Winlevi® is a first-in-class topical drug for the treatment of acne approved by U.S. FDA inAugust 2020. * It will reinforce our Proprietary Brand segment's dermatological franchise. SINGAPORE, Dec. 23, 2022 /PRNewswire/ -- Hyphens Pharma International Limited (" Hyphens Pharma", or the "Comp...

2022-12-23 17:00 3033

FDA agrees to Actinogen six-month Phase 2b Alzheimer's Disease trial

Exploring Xanamem® and the "cortisol hypothesis" for more than 6 million Americans suffering from Alzheimer's Disease[1] SYDNEY, Dec. 22, 2022 /PRNewswire/ -- Actinogen Medical Limited (ASX: ACW) is pleased to announce receipt today of agreement from the US Food and Drug Administration (FDA) to...

2022-12-22 20:30 2866

IASO Bio Announces U.S. FDA Approval of Clinical Trial Application for BCMA CAR-T CT103A for Relapsed/Refractory Multiple Myeloma

SHANGHAI and NANJING, China and SAN JOSE, Calif., Dec. 22, 2022 /PRNewswire/ -- IASO Biotherapeutics (IASO Bio), a clinical-stage biopharmaceutical company engaged in discovering, developing, and manufacturing innovative cell therapies and antibody products,, today announced that the Investiga...

2022-12-22 16:38 2950

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