-
China’s NMPA Shifts to Electronic Drug Filings from January 2023
•
China’s National Medical Products Administration (NMPA) has released a notification indicating the initiation of electronic drug filings, replacing paper filings, starting from January 2023. This move aims to streamline the drug registration process and enhance efficiency. Implementation DetailsApplicants are required to prepare electronic application materials in accordance with relevant regulations…
-
Hainan Hospital Launches IBI’s Smartbone ORTHO for Bone Repair
•
The clinical application of Smartbone ORTHO, a polyester collagen bone repair material introduced by Hainan Susheng Biotechnology from Swiss firm IBI, has been indicated on the website of China’s National Development and Reform Commission (NDRC). The material is being used at Ruijin Hospital’s branch in the Bo’Ao Lecheng Medical Tourism…
-
CSL Vifor and Fresenius Kabi Win China Approval for Ferinject
•
Swiss firm CSL Vifor and Germany’s Fresenius Kabi have announced the first regulatory approval in China for Ferinject (ferric carboxymaltose), an iron deficiency treatment used to manage anemia in patients with chronic kidney disease and those undergoing surgery. The drug is indicated for adults with iron deficiency for whom oral…
-
China’s Pharma Firms Collaborate on Generic Version of Sun Pharma’s Carbamazepine
•
Several China-based pharmaceutical companies, including Shanghai Zhongxi Sunve Pharmaceutical Co. Ltd, Shanghai Anbison Lab Co., Ltd, Qingdao BAHEAL Pharmaceutical Co., Ltd, and SPH Pharmaceutical Sales Co., Ltd, have agreed to collaborate on the development and marketing of Anbison Lab’s first generic version of carbamazepine sustained-release tablets (II) in China. The…
-
Youcare’s YKYYO17 Aerosol Inhalation Agent Approved for COVID-19 Clinical Study
•
China-based Youcare Pharmaceutical Group’s YKYYO17 aerosol inhalation agent, a broad-spectrum coronavirus membrane fusion inhibitor polypeptide drug, has been approved in China for a clinical study in COVID-19 infection. Drug Mechanism and DevelopmentThe Category 1 drug candidate, co-developed by the Institute of Medical Biology, Chinese Academy of Medical Sciences, can play…
-
Henan Celnovte Biotechnology Raises RMB 100M in New Financing Round
•
China-based Henan Celnovte Biotechnology Co., Ltd, a tumor in vitro diagnostic reagents (IVDs) and instruments maker, reportedly raised RMB 100 million (USD 14.15 million) via another financing round. Investors included Puhua Capital, Henan Hi-Tech Venture Capital, Zhengzhou High Tech Industry Investment Fund, and Zhong Yuan Lian Chuang Capital. Company Background…
-
Clover Biopharmaceuticals’ SCB-2019 Vaccine Reduces Household Transmission of COVID-19
•
China-based vaccine specialist Clover Biopharmaceuticals, Ltd (HKG: 2197) announced that Clinical Infectious Diseases has published additional data from SPECTRA, a global Phase II/III clinical trial, that showed vaccination with SCB-2019 (CpG 1018/Alum) reduced the risk of transmitting SARS-CoV-2 infection to household members, compared to placebo participants. Trial Results and ImplicationsThere…
-
Ascletis Pharma Completes Enrollment for ASC40 Phase II Acne Study
•
China-based Ascletis Pharma Inc. (HKG: 1672) announced the completion of enrollment of 180 patients in a Phase II clinical study for ASC40 (denifanstat). The molecule is set to be assessed in treating moderate to severe acne. The study is currently still blinded. Study Design and ObjectivesThe randomized, double-blind, placebo-controlled, multicenter…
-
Ascletis Pharma’s COVID-19 Drug Candidate ASC11 Accepted for Review by NMPA
•
China-based Ascletis Pharma Inc. (HKG: 1672) has announced that its Investigational New Drug (IND) filing for ASC11, an oral inhibitor drug candidate targeting 3-chymotrypsin like protease (3CLpro) for COVID-19, has been accepted for review by the National Medical Products Administration (NMPA). Drug Profile and PotencyIn antiviral cellular assays with infectious…
-
Hangzhou Polymed Biopharmaceuticals Raises Funds for Clinical Pipeline
•
China-based Hangzhou Polymed Biopharmaceuticals has reportedly completed a Pre-Series A+ financing round, raising an undisclosed amount of money. The proceeds will be used to accelerate Investigational New Drug (IND) filings and clinical trials for its two pre-clinical candidate drugs. Company Focus and PipelinePolymed Bio specializes in the development of bifunctional…
-
Fosun Pharma Weighs Sale of India’s Gland Pharma Amid Market Interest
•
Shanghai Fosun Pharmaceutical Group Co. (HKG: 2196, SHA: 600196) is reportedly considering the sale of its India-based majority-owned Gland Pharma Ltd (BOM: 543245), according to a Bloomberg report. This follows interest from potential buyers, as cited by insiders. Market Interest and Early StagesFosun is reportedly in the early stages of…
-
Fosun Pharma’s Gland Pharma to Acquire French CDMO Cenexi for EUR 120 Million
•
Shanghai Fosun Pharmaceutical Group Co (SHA: 600196) announced that its India-based subsidiary, Gland Pharma Ltd (BOM: 543245), plans to acquire privately held French pharmaceutical firm Cenexi for EUR 120 million (USD 124 million). In addition to the purchase price, Fosun Pharma will provide shareholder loans to Cenexi, with the total…
-
Luye Pharma Initiates Phase II Study for LY 03014 in China
•
China-based Luye Pharma Group (HKG: 2186) has announced the first patient dosing in a Phase II clinical study for its Category 1 drug candidate, LY 03014. The multi-center, randomized, double-blind, placebo-controlled, and positive drug parallel control study aims to assess the preliminary efficacy and safety of the drug in treating…
-
China’s Drug-Eluting Stent Procurement Results Announced
•
The national high-value medical consumables alliance procurement office has released the results of the successive procurement of coronary artery drug-eluting stent systems following the expiration of volume-based procurement (VBP) agreements. A total of 14 products from 10 manufacturers were awarded spots, according to the document, which is open for public…
-
Zhejiang Jiuzhou Pharma to Raise RMB 2.5 Billion via Private Placement
•
China-based Zhejiang Jiuzhou Pharmaceutical Co., Ltd (SHA: 603456) has received approval from the China Securities Regulatory Commission (CSRC) to conduct a private placement of 70 million shares. The company plans to raise RMB 2.5 billion (USD 350 million) through this transaction, with proceeds allocated towards the Phase 1 construction of…
-
Frontier Biotechnologies Partners with CASAPC for AIDS Prevention in China
•
China-based Frontier Biotechnologies Inc. (SHA: 688221) has announced a collaboration agreement with the Chinese Association of STD and AIDS Prevention and Control (CASAPC) to facilitate precision prevention and control of AIDS in China. The partnership aims to enhance the effectiveness of existing measures and better allocate resources for combating the…
-
Henlius Completes First Dosing in Head-to-Head Study of PD-1 Inhibitor HanSiZhuang
•
Shanghai Henlius Biotech (HKG: 2696) has announced the completion of the first subject dosing in a head-to-head bridging study for its programmed death-1 (PD-1) inhibitor, HanSiZhuang (serplulimab). The study is evaluating serplulimab as a first-line treatment for extensive-stage small cell lung cancer (ES-SCLC) against Roche’s PD-L1 inhibitor Tecentriq (atezolizumab), the…
-
JancsiTech Raises Tens of Millions in Angel Round Led by Yuanbio Venture Capital
•
JancsiTech, a precision nuclear medicine specialist based in Shenzhen, has reportedly raised “tens of millions” of renminbi in an angel financing round led by Yuanbio Venture Capital. Existing investor Sequoia Capital China also participated in the round. The proceeds will be directed towards research and development, innovation of intelligent medical…
-
FDA Rejects Spectrum’s Poziotinib NDA for NSCLC Treatment
•
US-based Spectrum Pharmaceuticals Inc. (Nasdaq: SPPI) announced last week that its New Drug Application (NDA) for poziotinib, a treatment for previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC) with HER2 exon 20 insertion mutations, received a complete response letter (CRL) from the US FDA. The CRL cited…
-
Sino Biological to Invest RMB 1 Billion in Beijing Bio-Pharmaceutical Park
•
Sino Biological, Inc. (SHE: 301047) has announced plans to invest RMB 1 billion (USD 140 million) to create a one-stop biological reagent and technology service platform. The initiative also includes the development of a comprehensive bio-pharmaceutical innovation service park in the Beijing Economic-Technological Development Area. As of the announcement date,…
