Pharmaceuticals
Peijia Medical Presents Early Clinical Findings of GeminiOne® TEER Device at TCT 2023
SUZHOU, China, Oct. 27, 2023 /PRNewswire/ -- Peijia Medical Limited (Peijia, (9996.HK)), a leading Chinese medical device player in transcatheter structural heart device and neurovascular device, presented its GeminiOne® TEER technology, along with the early clinical experiences of the device at ...
Henlius Deepens Collaboration with Intas to bring Henlius' Novel anti-PD-1 mAb Serplulimab to Europe and India
* The footprint of serplulimab now includes the United States, Europe, Southeast Asia, MENA, and India * Intas to develop and commercialise serplulimab in Europe and India; Henlius to receive €42 million upfront payment, double-digit royalties and up to €143 million in regulatory and commerc...
Chime Biologics and Hope Medicine Enter Manufacturing Agreement to Speed up the Launch of First-in-class Antibody Drug HMI-115 Targeting Endometriosis and Androgenic Alopecia
* Chime Biologics to support the late-stage clinical study and to provide global commercial manufacturing services forHope Medicine's first-in-class monoclonal antibody drug, HMI-115. * The first-in-class mAb will benefit endometriosis and androgenetic alopecia patients. SHANGHAI, Oct. 26, 20...
Clarity and PSI kick off SAR-bisPSMA Phase III
SYDNEY, Oct. 26, 2023 /PRNewswire/ -- Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), a clinical stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, and PSI CRO AG ("PSI"), a global contract rese...
HanAll Biopharma Reports Third Quarter 2023 Financial Results and Provides a Business Update
* Sales recorded KRW 33 billion in Q3 2023, an 11 percent increase from the same period in 2022, due to the sustained growth of major products. * 'HL161ANS', HanAll's second anti-FcRn antibody, demonstrated best-in-class potential through the initial outcome of Phase 1 study. * 'HL192', a Nu...
Bridge Biotherapeutics Announces Positive Recommendation from the Independent Data Monitoring Committee of the BBT-877 Phase 2a Study in Idiopathic Pulmonary Fibrosis
* The independent data monitoring committee (IDMC) recommended the continuation of the BBT-877 Phase 2a trial based on the initial clinical data from the first 20 participants dosed with theinvestigational product * No safety concerns were raised based on the evaluation of the data presented ...
Neuragenex Brings Innovative Fibromyalgia Treatment to Patients Across the US
GULBERT, Ariz., Oct. 25, 2023 /PRNewswire/ -- Neuragenex, the national healthcare provider focused on non-pharmaceutical pain treatment, announced its continued expansion to bring relief to fibromyalgia patients across the country. With clinics now operating in Georgia, Texas, Illinois, Tenness...
Qilu Pharmaceutical announces the latest results from its clinical study on QL1706, in combination with chemotherapy, as a first-line treatment for recurrent or metastatic cervical cancer
JINAN, China, Oct. 25, 2023 /PRNewswire/ -- On October 22, Qilu Pharmaceutical unveiled the latest findings from a multicenter, single-arm Phase II clinical trial at the European Society for Medical Oncology (ESMO) Annual Congress 2023. This trial studied the use of QL1706 (iparomlimab and tuvonr...
First Patient Dosed for MRCT Phase 3 Study on First-Line LS-SCLC of Henlius Anti-PD-1 mAb Serplulimab in Europe
SHANGHAI, Oct. 25, 2023 /PRNewswire/ -- Shanghai Henlius Biotech, Inc. (2696.HK) announced that the first patient inEurope has been dosed in the international multi-centre phase 3 clinical trial (NCT05353257) of the company's self-developed anti-PD-1 mAb HANSIZHUANG (serplulimab) in combination ...
Good Safety Profile and Antitumor Activity: Oral Presentation of Mabwell's 9MW2821 at 2023 ESMO
Shanghai, Oct. 25, 2023 /PRNewswire/ -- ESMO Congress 2023 was held in Madrid, Spain from October 20-24, the preliminary results of the Phase I/II study of 9MW2821 (Nectin-4 targeting ADC) in patients with advanced solid tumors were reported by Dr.Jian Zhang of Fudan University Shanghai Cancer Ce...
Phase Ib/II Results of Akeso's PD-1/CTLA-4 Bispecific Antibody for First-Line Treatment of Advanced Hepatocellular Carcinoma Published at 2023 ESMO
HONG KONG, Oct. 24, 2023 /PRNewswire/ -- Akeso announced poster presentation at the 2023 European Society for Medical Oncology (ESMO) Congress from its cadonilimab ( PD-1/CTLA-4 bispecific antibody) combined with lenvatinib for first-line treatment of Advanced Hepatocellular Carcinoma (HCC). The ...
Clinical Trial Application (IND) for BioRay Pharmaceutical's BR105 Injection Receives U.S. FDA Approval
SHANGHAI, Oct. 24, 2023 /PRNewswire/ -- BioRay Pharmaceutical Co., Ltd. (hereinafter referred to as "BioRay") announced onOctober 7th that its clinical trial application for BR105 Injection has received approval from the United States Food and Drug Administration (FDA). This marks BioRay's first ...
OBiO Announces Strategic Partnership with Refreshgene to Realize Commercialization of Gene Therapy Product
Visit OBiO at ESGCT 30th Annual Congress in Brussels SHANGHAI, Oct. 24, 2023 /PRNewswire/ -- OBiO Technology (Shanghai) Corp., Ltd. (OBiO, 688238.SH), a world leading contract development and manufacturing organization for cell and gene therapy, officially announced an agreement with Refreshgene...
Certa Therapeutics' FT011 Granted US FDA Orphan Drug Designation for the Treatment of Systemic Sclerosis
MELBOURNE, Australia, Oct. 23, 2023 /PRNewswire/ -- Certa Therapeutics (Certa), a biotechnology company developing innovative precision therapies for patients with inflammatory and fibrotic diseases, today announces that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation ...
Live from ESMO 2023 | Oral Report Featuring Latest Data of Pelcitoclax (APG-1252) Combined with Osimertinib Demonstrates Potential as a New Treatment Option for TP53-and EGFR-Mutant NSCLC
SUZHOU, China and ROCKVILLE, Md., Oct. 23, 2023 /PRNewswire/ -- Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancer, chronic hepatitis B (CHB), and age-related diseases, announced today that it has released the latest clinical data of it...
Mabwell Announces Latest Clinical Progress and Data to be Reported on ESMO 2023 of 2 Novel Drugs
SHANGHAI, Oct. 23, 2023 /PRNewswire/ -- Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announces the latest clinical progress of 2 novel drugs including Nectin-4 ADC 9MW2821, as well as the clinical study data to be reported on ESMO 2023. Latest progress...
Sunvozertinib Demonstrates Best-in-Class Potential as a First-Line Treatment for EGFR Exon 20 Insertion Mutation-Positive Non-Small Cell Lung Cancer Patients
* Sunvozertinib monotherapy demonstrated superior efficacy and excellent safety in patients in the 1st line setting for advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) Exon 20 insertion (Exon20ins) mutations, achieving a confirmed objective...
InxMed Releases Data Demonstrating Ifebemtinib (IN10018) Trending Toward Survival Benefit at ESMO 2023
NANJING, China, Oct 22, 2023 /PRNewswire/ -- InxMed Co., Ltd, a clinical-stage biotechnology company dedicated on developing innovative therapies to overcome drug resistance for hard-to-treat solid tumors, announces that clinical data of Ifebemtinib (IN10018), a highly potent and selective oral i...
Jacobio Pharma Presents Clinical Results of Glecirasib in Combination with JAB-3312 at ESMO
* The ORR (objective response rate) and the DCR (disease control rate) in the frontline setting of glecirasib (KRAS G12C Inhibitor) in combination with JAB-3312 (SHP2 inhibitor) were 65.5% (38/58) and 100% respectively in all dose groups of advanced non-small cell lung cancer (NSCLC), among whi...
Zhimeng Biopharma CB03 Received Orphan Drug Designation from the US FDA - A Potassium Ion Channel Opener for Amyotrophic Lateral Sclerosis
SHANGHAI, Oct. 20, 2023 /PRNewswire/ -- Shanghai Zhimeng Biopharma, Inc. ("Zhimeng"), announced that one of its innovative small-molecule KCNQ2/3 selective opener compounds (CB03), developed for the treatment of amyotrophic lateral sclerosis (ALS), received orphan drug designation (ODD) from US F...
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