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Betta Pharmaceuticals Enrolls First Patient in BPI-442096 Phase I Study for Solid Tumors
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China-based Betta Pharmaceuticals (SHE: 300558) announced that the first subject has been enrolled in a Phase I clinical study of BPI-442096 for advanced solid tumors. The multi-center trial, which includes dosage escalation and expansion phases, will assess the safety, tolerability, and preliminary efficacy of BPI-442096, and determine the maximum tolerated…
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Hengrui Medicine’s SHR-A1811 Combo Receives NMPA Approval for HER2+ NSCLC Study
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China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase Ib/II clinical study of SHR-A1811, a HER2-targeted antibody drug conjugate (ADC), combined with SHR-1316 or pyrotinib for advanced non-small cell lung cancer (NSCLC) with HER2…
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Ascentage Pharma Launches Olverembatinib Named Patient Program with Tanner Pharma
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China-based Ascentage Pharma (HKG: 6855) announced the launch of a Named Patient Program (NPP) for its drug olverembatinib in partnership with US-based Tanner Pharma Group. The program aims to provide access to the drug in over 100 countries and regions where it is not yet commercially available. Drug ProfileOlverembatinib is…
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Sirnaomics’ STP705 Receives Approval for Liver Cancer Trial in Taiwan
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Sino-US siRNA therapy developer Sirnaomics Ltd (HKG: 2257) announced that it has received approval from the Ministry of Health and Welfare of Taiwan to conduct a Phase I clinical study of its therapeutic candidate STP705 for advanced liver cancer. Drug ProfileSTP705 is a siRNA (small interfering RNA) therapeutic that leverages…
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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.…
