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Willingmed Secures Series B Funding to Advance Clinical Infection Diagnostics
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Willingmed, a Beijing-based company specializing in molecular biology for clinical infection precision diagnosis, has reportedly secured hundreds of millions of renminbi in a Series B financing round. The round was led by Galaxy Capital, Haier Capital, and Hunan Hi-Tech Venture Capital Health & Elderly Care Fund. The funds raised will…
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CDE Launches Guidelines to Expedite Pediatric and Rare Disease Drug Reviews
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The Center for Drug Evaluation (CDE) has unveiled a new set of “Work Specifications to Accelerate Novel Drug Market Filing Reviews,” targeting the acceleration of innovative pediatric and rare disease drug development, as well as the overall advancement of innovative drug research and development. Scope of Application: Innovative Pediatric and…
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Johnson & Johnson’s Talquetamab on Track for Breakthrough Therapy Designation in Multiple Myeloma
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China’s Center for Drug Evaluation (CDE) has indicated that US pharmaceutical giant Johnson & Johnson’s (J&J, NYSE: JNJ) GPRC5D/CD3 bispecific antibody (BsAb) talquetamab is on track to receive breakthrough therapy designation (BTD) for the treatment of recurrent or refractory (R/R) multiple myeloma (MM) in patients who have undergone at least…
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CSPC Pharmaceutical Receives FDA Approval for Phase I Study of CPO301 in Lung Cancer
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase I clinical study assessing the safety, pharmacokinetics, and preliminary efficacy of its antibody-drug conjugate (ADC) CPO301 in patients with advanced lung cancer characterized by…
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Shanghai Fosun Pharmaceutical Gets NMPA Approval for FCN-338 Phase II Study
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China-based Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study for its pipeline drug candidate, FCN-338. The study will assess the efficacy of FCN-338 in treating malignant hematological diseases of the…
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Mabwell Bioscience Receives NMPA Approval for Biosimilar Version of Amgen’s Prolia
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China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced receiving market approval from the National Medical Products Administration (NMPA) for its biosimilar version of US major Amgen’s Prolia (denosumab). This development marks Mabwell’s drug as the world’s second biosimilar of Prolia, which is used to treat osteoporosis in postmenopausal…
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Roche’s Cosentyx 300mg Dosage Approved by NMPA for Ankylosing Spondylitis Treatment
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Swiss pharmaceutical giant Roche (SWX: ROG) has announced that the National Medical Products Administration (NMPA) has approved the 300mg dosage regimen of Cosentyx (secukinumab) for use in treating ankylosing spondylitis (AS). This approval represents a significant advancement in the management of this chronic inflammatory disease. Approval Based on MEASURE 3…
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Changzhou Qianhong Bio-pharma Receives NMPA Approval for QHRD107 Phase II AML Study
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China-based Changzhou Qianhong Bio-pharma Co., Ltd (SHE: 002550) has announced obtaining approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study for its Category 1 drug QHRD107 in acute myeloid leukemia (AML). The drug is being developed for use in combination with venetoclax and/or azacitidine,…
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Konruns Pharmaceutical Reports Positive Efficacy Results for KC1036 in Advanced ESCC
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Beijing-based Konruns Pharmaceutical Co., Ltd (SHA: 603590) has announced the publication of efficacy study results for its Category 1 chemical drug, KC1036, in the treatment of advanced esophageal squamous cell carcinoma (ESCC). The drug was evaluated as a second-line therapy for patients who have already failed previous standard treatments. Study…
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Boao Lecheng Medical Tourism Zone Partners with Eye Valley to Advance Ophthalmology Innovation
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The Boao Lecheng Medical Tourism Pilot Zone in Hainan Province has announced a strategic partnership with the Eye Valley in Wenzhou. This collaboration aims to promote the transformation of significant scientific and technological achievements in ophthalmology, attract high-level talent for innovation and entrepreneurship, and support the development of high-quality pharmaceutical…
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Cellular Biomedicine Group Initiates Phase III Study for AlloJoin in Knee Osteoarthritis
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China-based cell therapy specialist Cellular Biomedicine Group Inc. (CBMG) has announced the initiation of a Phase III clinical study for its allogeneic human adipose mesenchymal progenitor cell injection, AlloJoin. This follows a successful randomized, double-blind, controlled multi-center Phase II clinical study, which included a 96-week follow-up and preliminarily demonstrated a…
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Abbisko Therapeutics Secures Orphan Drug Designation for FGFR4 Inhibitor ABSK012
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received orphan drug designation (ODD) status from the US Food and Drug Administration (FDA) for its next-generation FGFR4 mutant inhibitor, ABSK012, intended for the treatment of soft-tissue sarcoma. Preclinical Efficacy of ABSK012 Against FGFR4 MutantsPreclinical studies have…
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Henlius Reports 91.1% Revenue Growth in 2022, Driven by Product Commercialization
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China-based Henlius (HKG: 2696) has announced its annual results for 2022, revealing that revenues reached RMB 3.214 billion (USD 466.5 million), representing a remarkable increase of 91.1% year-on-year (YOY). This growth was driven by the successive commercialization of various products, with the company currently having launched five products in China…
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Everest Medicines Reports 2022 Revenue Growth and Pipeline Updates
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China-based Everest Medicines (HKG: 1952) has released its financial report for 2022, along with key business updates. The company reported revenues of RMB 12.8 million (USD 1.86 million) for the year ending 31 December 2022, an increase of RMB 12.7 million (USD 1.84 million) compared to the previous year, primarily…
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ClouDr Partners with Banbiantian to Digitalize Medicine and Medical Device Sector
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Hangzhou Kang Ming Information Technology Co., Ltd, trading under the name “ClouDr” (HKG: 9955), has entered into a strategic partnership with Wuhan Banbiantian Medical Technology Development Co., Ltd. The collaboration, which is centered around digitalization technologies, is designed to capitalize on the “medicine, device, drug” linkage model. While financial specifics…
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Pharmaron Secures UK Government Grant to Expand Viral Vector Manufacturing Facility
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China-based Contract Development and Manufacturing Organization (CDMO) Pharmaron Beijing Co., Ltd (HKG: 3759, SHE: 300759) has announced the receipt of a substantial grant from the UK government’s Life Sciences Innovation Manufacturing Fund (LSMIF). The grant will facilitate the expansion of Pharmaron’s existing viral vector and DNA manufacturing facility in Liverpool,…
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HutchMed Completes NDA Submission to US FDA for Frquintinib in Metastatic CRC
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Hutchison China Meditech (HutchMed; HKG: 0013, NASDAQ: HCM) has announced the completion of a rolling submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for its oral inhibitor of VEGFR-1, -2, and -3, fruquintinib. The drug is proposed for the treatment of refractory metastatic…
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Apollomics Inc. Completes Merger with Maxpro Capital, Lists on NASDAQ as ‘APLM’
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Sino-US biotech firm Apollomics Inc. has announced the successful completion of a merger with the special purpose acquisition company (SPAC) Maxpro Capital Acquisition Corp., This strategic move allows Apollomics’ A shares and warrants to be traded on the NASDAQ under the ticker symbols “APLM” and “APLMW” respectively. The merger, which…
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Huadong Medicine Wins NMPA Approval for Liraglutide Biosimilar for Type 2 Diabetes
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Huadong Medicine Co., Ltd (SHE: 000963), a leading China-based pharmaceutical company, has announced that it has received market approval from the National Medical Products Administration (NMPA) for its biosimilar version of Novo Nordisk’s Victoza (liraglutide). This new biosimilar is intended for use in treating patients with type 2 diabetes. Liraglutide…
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Ablaze Pharma Charts Path for GPC3-Targeted Polypeptide with RayzeBio Partnership
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Ablaze Pharma, a Chinese biopharmaceutical company, has announced its development plan for a GPC3-targeted polypeptide drug candidate, as part of an ongoing licensing deal with US-based RayzeBio. The agreement aims to develop and commercialize the product in Greater China, expanding Ablaze’s portfolio and strengthening its commitment to cancer therapies. Licensing…
