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GenFleet Therapeutics’ GFH018 Receives CTA Approval for Two Clinical Trials in China
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Shanghai-based biotech company GenFleet Therapeutics announced that two clinical trial applications (CTAs) for its drug candidate GFH018 have been approved in China. GFH018 is a small molecule designed to specifically target and inhibit TGF-ß R1. Clinical Trial Details SignificanceThe TGF-ß signaling pathway is a key target for multiple solid tumors.…
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NMPA Approves Genuine Biotech’s Azvudine for COVID-19, Fosun Pharma Inks Licensing Deal
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China’s National Medical Products Administration (NMPA) has conditionally approved HeNan Genuine Biotech Co., Ltd’s azvudine for the treatment of COVID-19 infection. The drug, originally approved in July 2021 for adult HIV-1 patients with high viral loads, can now be used to treat ordinary COVID-19 adult patients. Licensing AgreementShanghai Fosun Pharmaceutical…
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Chinese Pharmacists Association Releases Draft VBP Drug Management Guidelines for Public Feedback
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The Chinese Pharmacists Association (CPA) has released the “National Volume-based Procurement (VBP) Drug Management Expert Consensus for Medical Institutions,” a draft proposal open for public feedback until March 31, 2022. The document provides guidance on standardizing, homogenizing, normalizing, and institutionalizing the implementation of the national VBP drug policy. Key Guidelines…
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3D Medicines Files IPO Prospectus for Hong Kong Listing
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China-based oncology specialist 3D Medicines has published its initial public offering (IPO) prospectus with the Hong Kong Stock Exchange (HKSE), though the issuance amount and price have yet to be disclosed. Company ProfileFounded in 2014, 3D Medicines has a product pipeline that includes envafolimab, a programmed-death ligand 1 (PD-L1) inhibitor…
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I-Mab Doses First Patient in Global Phase I Study for TJ-CD4B in Solid Tumors
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I-Mab (NASDAQ: IMAB), a Nasdaq-listed company since 2020, announced that the first patient has been dosed in a global multi-center Phase I clinical study for its TJ-CD4B (ABL111), a bispecific antibody (BsAb) targeting Claudin 18.2 (CLDN18.2) and 4-1BB, in solid tumors including gastric cancer, gastroesophageal junction cancer, esophageal adenocarcinoma, and…
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Rona Therapeutics Licenses Sanofi’s siRNA Platform for Global Development
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Shanghai-based RNA therapeutics specialist Rona Therapeutics has entered into a licensing agreement with French pharmaceutical giant Sanofi, securing exclusive worldwide rights to Sanofi’s siRNA platform of chemical modification and delivery moiety, as well as rights to four pre-clinical candidates targeting undisclosed indications. Deal HighlightsThe agreement significantly expands Rona’s pipeline in…
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ApolloBio Corp. Initiates Pre-Clinical Study for ABC-5100 Nanobody Against COVID-19
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ApolloBio Corp. (NEEQ:430187) announced the initiation of a pre-clinical study for its novel broad-spectrum anti-COVID-19 nanobody, ABC-5100. The drug is designed to prevent or provide early treatment for SARS-CoV-2 coronavirus infections. Pre-Clinical Study DetailsABC-5100 has demonstrated efficacy against various variants of concern (VOCs), including Omicron. The nanobody can be administered…
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InventisBio Raises USD 308M in Shanghai STAR IPO, Valued at USD 1.54B
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China-based biotech firm InventisBio (SHA: 688382) has completed an initial public offering (IPO) of 115 million shares on the Shanghai Stock Exchange’s Science and Technology Innovation Board (STAR). The shares were priced at RMB 18.12 (USD 2.68) each, raising a total of RMB 2.08 billion (USD 308 million) and valuing…
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NMPA Releases 56th Batch of GQCE Reference Drugs, Including 14 Injectables
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The National Medical Products Administration (NMPA) has released the 56th batch of reference drugs for generic quality consistency evaluation (GQCE) work, including 14 injectables among a total of 74 new specifications. Batch DetailsThe latest batch comprises 74 new drug specifications, with 14 being injectables. This marks the continued expansion of…
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MobiDrop Raises USD 14.8M in Series A+ to Expand Single-Cell Product Pipeline
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China-based MobiDrop (Zhejiang) Co., Ltd has reportedly raised close to RMB 100 million (USD 14.8 million) in a Series A+ financing round led by LYFE Capital. Existing investor Source Code Capital and a government-led fund also participated. Funding UseProceeds will support the expansion of MobiDrop’s single-cell product pipeline, research and…
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Luye Pharma’s LY01005 Meets Phase III Trial Goals in Breast Cancer Treatment
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China-based Luye Pharma Group (HKG: 2186) announced that its Phase III clinical study for LY01005 in breast cancer treatment has successfully met pre-set endpoints. The study demonstrated that LY01005 effectively controls serum estradiol to postmenenopausal levels, with clinical efficacy comparable to a control drug, achieving a non-inferiority standard. Study DetailsThe…
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ZGC Shuimu Medtech Raises RMB 100M in Series A+ Round Led by Yijing Capital
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Beijing-based ZGC Shuimu Medical Technology Services Group, China’s first private third-party medical device testing institution, has reportedly raised RMB 100 million (USD 18.8 million) in a Series A+ financing round. The round was led by Yijing Capital and Green Pine Capital Partners. This follows the company’s Series A financing round…
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Innovita Biological Technology’s IPO Raises USD 131.3M for POCT Expansion
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Innovita Biological Technology Co., Ltd, a Beijing-based point-of-care testing (POCT) specialist, is set to make an initial public offering (IPO) of 34.02 million shares on Shanghai’s Sci-Tech Innovation Board (STAR). The shares are priced at RMB 26.06 (USD 3.86) each, with the listing expected to raise RMB 887 million (USD…
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Fidia Farmaceutici’s Hyalubrix 60 Shows Promise in Treating Arthropathy at Hainan Hospital
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Italy-based Fidia Farmaceutici S.p.A announced that its Hyalubrix 60, a prefilled syringe with sodium hyaluronate solution for intra-articular injection, has successfully completed treatment in four patients at Hainan General Hospital’s Lecheng branch. Product ProfileHyalubrix 60 is designed to restore the viscoelastic properties of knee and hip synovial fluid. It serves…
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Linno Pharmaceuticals Raises USD 14.78M for Blood-Brain Barrier Drug Delivery Tech
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Shanghai-based rare disease specialist Linno Pharmaceuticals Inc. has reportedly raised close to RMB 100 million (USD 14.78 million) in angel and pre-Series A financing rounds. The round was led by Puhua Capital, with contributions from Zhangke Lingyi Investment. Funding UseProceeds will support upgrades in blood-brain barrier-crossing macromolecular drug delivery technology…
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Frontier Biotech Raises USD 51.4M to Advance COVID-19 Drug FB2001
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China-based Frontier Biotechnologies Inc. (SHA: 688221) announced plans to raise RMB 270 million (USD 51.4 million) through a private placement to support the development of its COVID-19 drug candidate FB2001. The funding will be used for a Phase I clinical study, global Phase II/III trials, and quality and process studies.…
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Curatia Medical Raises Tens of Millions in Funding Co-led by Hidea Investment
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Curatia Medical Ltd, a vascular interventional therapy developer with operations in Silicon Valley, California, and Suzhou, China, has reportedly raised tens of millions of renminbi in its latest financing round, co-led by Hidea Investment. Company BackgroundFounded in 2015, Curatia specializes in biomaterials, machinery, coatings, metal weaving, extrusion, abrasives, and other…
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Novaremed AG Licenses NRD.E1 to NeuroFront for Greater China Development
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Switzerland-based Novaremed AG has entered into a licensing agreement with China’s NeuroFront (Shanghai) Co., Ltd, granting NeuroFront exclusive rights to develop, commercialize, and manufacture NRD.E1 in Greater China, including mainland China, Hong Kong, Macau, and Taiwan. In exchange, Novaremed will receive upfront and milestone payments totaling USD 130 million. Drug…
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Ascentage Pharma’s Olverembatinib Receives Health Canada Approval for Phase Ib Study
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Suzhou-based Ascentage Pharma (HKG: 6855) announced that it has received approval from Health Canada to conduct a Phase Ib clinical study of its third-generation BCR-ABL-targeted tyrosine kinase inhibitor (TKI), olverembatinib (HQP1351), for drug-resistant chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL). Study DetailsThe open-label, multi-center, randomized, global…
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Junshi Biosciences’ Toripalimab Receives EC Orphan Drug Designation for NPC
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China-based Junshi Biosciences (HKG: 1877, SHA: 688180) announced that its PD-1 inhibitor Toripalimab (trade name: Tuoyi) has received orphan drug designation (ODD) from the European Committee (EC) for the treatment of nasopharyngeal carcinoma (NPC). This marks the sixth ODD for Toripalimab in the US and Europe, following previous designations for…
