-
Innovent’s Tyvyt Approved for New Gastric Cancer Indication by NMPA
•
China-based Innovent Biologics, Inc. (HKG: 1801) and its partner Eli Lilly & Co. (NYSE: LLY) announced that the PD-1 inhibitor Tyvyt (sintilimab) has been approved by the National Medical Products Administration (NMPA) for a new indication. The drug is now approved to treat first-line unresectable locally advanced, recurrent, or metastatic…
-
Zhejiang Huahai Receives FDA ANDA Approval for Generic Tecfidera
•
China-based Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) announced that it has received Abbreviated New Drug Application (ANDA) approval from the US FDA for its generic version of Biogen’s Tecfidera (dimethyl fumarate). The application was filed by Huahai’s US unit, Prinston Pharmaceutical Inc. Tecfidera: Drug Profile and Market ContextTecfidera is…
-
Novartis Expands Strategic Collaboration with Bo’Ao Lecheng Pilot Zone
•
Novartis (NYSE: NVS) announced a further strategic collaboration with the Bo’Ao Lecheng Medical Tourism Pilot Zone, where it will establish a Novartis Hainan office and a real-world study center. The initiative aims to strengthen cooperation and exchange in real-world studies and clinical drug research and development, as well as promote…
-
Salubris Partners with Alpha Molecular for AI-Driven Obesity Drug Development
•
China’s Shenzhen Salubris Pharmaceuticals Co., Ltd (SHE: 002294) has entered into a partnership with compatriot firm Shenzhen Alpha Molecular Technology Co., Ltd to enhance the artificial intelligence (AI)-empowered research and development of obesity drugs. The collaboration aims to leverage the combined strengths of both companies in the field of drug…
-
RemeGen Reports 397.47% YOY Revenue Growth in Q3 2022
•
China-based pharma firm RemeGen (HKG: 9995) released its Q3 2022 financial report, showing significant growth in revenues and research and development (R&D) spending. During the first three months of the year, the company generated RMB 570 million (USD 78.6 million) in revenues, up 397.47% year-on-year (YOY). It spent RMB 663…
-
Innovent’s Parsaclisib Filed for Marketing Approval in China
•
China’s Center for Drug Evaluation (CDE) has received a marketing approval application for Innovent Biologics Inc’s (HKG: 1801) PI3Kδ inhibitor parsaclisib. The product candidate has been granted priority review status. The targeted indication is relapsed or refractory follicular lymphoma (r/r FL) in patients who have previously received at least two…
-
Proheal Pharmaceuticals Initiates Clinical Study for PHP1003 in Thyroid-Associated Ophthalmopathy
•
Proheal Pharmaceuticals, a Suzhou-based developer of drugs for ophthalmology and autoimmune diseases, announced the first subject dosing in a clinical study for its in-house developed anti-IGF1R antibody PHP1003 in thyroid-associated ophthalmopathy (TAO). This marks a significant milestone in the development of novel treatments for this condition. Study Design and Drug…
-
HutchMed Initiates Phase II/III Study for Elunate and Tyvyt in Renal Cell Carcinoma
•
China-based Hutchison China Meditech (HutchMed; NASDAQ: HCM, HKG: 0013) announced the initiation of a Phase II/III clinical study for Elunate (fruquintinib) combined with Tyvyt (sintilimab) as a second-line treatment for locally advanced or metastatic renal cell carcinoma (RCC) in China. The first patient was dosed this week. Study Design and…
-
Shanghai Pharmaceuticals Reports 12.86% YOY Revenue Growth in Q3 2022
•
Shanghai Pharmaceuticals (HKG: 2607, SHA: 601607) released its Q3 2022 financial report, recording RMB 62.904 billion (USD 8.7 billion) in revenues during the three months, up 12.86% year-on-year (YOY). The growth was driven by strong performances in both the pharmaceutical industry and pharmaceutical commerce sectors. Sector PerformanceThe “pharmaceutical industry” and…
-
Recbio’s Neoadjuvant HPV Vaccine Accepted for Review by NMPA
•
China-based vaccine maker Jiangsu Recbio Technology Co., Ltd (HKG: 2179) announced that a clinical trial filing for its in-house developed neoadjuvant recombinant tetravalent human papillomavirus (HPV) vaccine has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant step in the development of Recbio’s vaccine…
-
Kintor Completes Enrollment for GT20029 Phase I Study in US
•
China-based Kintor Pharmaceutical Ltd (HKG: 9939) announced the completion of enrollment for a Phase I clinical study of its GT20029, targeting androgenetic alopecia and acne. The study, which enrolled 120 subjects in the US, is a randomized, double-blind, placebo-controlled, parallel, dosage escalation trial designed to assess the safety, tolerability, and…
-
Alphamab Oncology Gains NMPA Approval for JSKN003 Clinical Trial
•
Alphamab Oncology (HKG: 9966) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase Ia/Ib clinical study for its JSKN003. The study will assess the safety and tolerability of JSKN003 in patients with advanced malignant solid tumors and determine the maximum tolerable dose…
-
WinHealth’s Ravicti Receives Orphan Drug Designation in Taiwan
•
China-based Hong Kong WinHealth Pharma Group Ltd announced that its Swiss partner Immedica Pharma AB’s Ravicti (glycerol phenylbutyrate) has received orphan drug designation (ODD) status in Taiwan. This rare disease drug, which is awaiting regulatory decisions in China with priority review status, can now be used as a long-term adjuvant…
-
Lee’s Pharmaceutical’s NVK-002 Shows Strong Results in Phase III CHAMP Study
•
China-based Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) subsidiary Zhaoke Ophthalmology Ltd (HKG: 6622) announced that its partner Vyluma Inc. has published the primary results of the Phase III CHAMP study. The results indicate that NVK-002, a potential treatment for myopia in children, has demonstrated strong safety and efficacy. NVK-002: Drug…
-
CSPC’s Antibody-Drug Conjugate SYS6002 Gains CDE Approval for Clinical Study
•
China-based CSPC Pharmaceutical Group Co., Ltd (HKG: 1093) announced that it has received approval from the Center for Drug Evaluation (CDE) to conduct a clinical study for SYS6002, an antibody-drug conjugate (ADC) developed in-house by its subsidiary CSPC Jushi Biopharmaceutical Co., Ltd. The intended indication for SYS6002 is advanced solid…
-
Luye Pharma’s Long-Acting IL-4Rα Antibody BA2101 Gains CDE Approval
•
China-based Luye Pharma Group (HKG: 2186) announced that its controlling subsidiary Shandong Boan Biotechnology Co., Ltd has received clinical trial approval from the Center for Drug Evaluation (CDE) for its in-house developed long-acting monoclonal antibody (mAb) BA2101. BA2101: Drug Profile and MechanismBA2101 is an innovative long-acting human monoclonal IgG4 antibody…
-
Ausper Biopharma’s COVID-19 Nasal Spray Antibody Gets NMPA Approval
•
Ausper Biopharma Inc., a Hangzhou-based developer of hepatitis B virus (HBV) drugs, announced that its joint venture Chongqing Mingdao Haoyue Biotechnology Co., Ltd has obtained clinical trial approval from the National Medical Products Administration (NMPA) for its nasal spray COVID-19 neutralizing antibody MY-586. Drug Mechanism and AdvantagesMY-586 is described as…
-
Merck’s Q3 Sales Rise on Key Drug Performances, China Growth
•
US-based Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK) reported its Q3 2022 financial results, with sales reaching USD 45.45 billion over the first nine months, marking a 32% year-on-year (YOY) growth excluding exchange rate impact. For the three months of Q3, the company generated USD 14.96 billion in sales,…
-
Salubris Partners with Anlong Bio for Small Nucleic Acid Drugs in Hypertension
•
China’s Shenzhen Salubris Pharmaceuticals Co., Ltd (SHE: 002294) has entered into a partnership with Beijing Anlong Biopharmaceutical Co., Ltd to jointly research and develop small nucleic acid drugs for the treatment of hypertension. The collaboration aims to leverage the combined expertise of both companies in the field of nucleic acid…
-
Shanghai Launches Inhaled COVID-19 Vaccine Booster Program
•
On October 25, Shanghai began accepting patient reservations for the inhalable recombinant COVID-19 vaccine (adenovirus type 5 vector) as a booster shot. The free booster immunization program indicates that the vaccine is currently unavailable for basic immunization. Eligibility CriteriaEligible for the one-shot booster immunization program are individuals aged 18 and…
