Deals and Financings

Hangzhou Sciwind Biosciences out-licensed South Korean rights for ecnoglutide injection (XW003), a novel long-acting GLP-1 analog aimed at type 2 diabetes, obesity and MASH, to HK inno.N Corporation (KOSDAQ: 195940) (see story). HK inno.N is a South Korean commercial stage pharmaceutical company. Sciwind will receive an unspecified upfront payment and additional milestones of up to $56 million, plus up to double-digit royalties on sales. XW003 is currently in a Phase III trial. In previous tests, it showed efficacy for type 2 diabetes and obesity without serious safety concerns. 

Beijing’s Sino Biological (SZE: 301047), a company that develops research reagents and offers contract research services, completed its $48 million acquisition of Vancouver-based SignalChem Biotech (SCB) (see story). SCB develops bioactive enzymes, including kinases, proteases, phosphatases, ubiquitin and epigenetic enzymes. Sino Biological said SCB will add enzyme production expertise to its own technology platforms. With SCB as a wholly owned subsidiary, Sino Biological expects to offer a wider range of products and research services, supporting novel treatments, vaccines and diagnostic platforms. 

Beijing’s Biocytogen Pharmaceuticals (HK: 02315) signed a TCR-mimic antibody evaluation and potential licensing agreement with BioCopy AG of Basel, Switzerland (see story). BioCopy will have access to fully human TCR-mimic antibodies targeting an intracellular antigen. The antibodies were generated by Biocytogen’s RenTCR-mimicTM mice. BioCopy, which will evaluate the TCR-mimic antibodies with an option to license them for novel cancer therapies, has an automated AI-based end-to-end platform that optimizes multispecific biotherapeutics to develop TCR-mimic antibodies into next-gen oncological drugs. 

Government and Regulatory

BIO, the US-based biopharma trade association, reported that 74% of respondents to a survey have business with China CDMOs (mostly WuXi AppTec) (see story). As a result, US (and other non-China biopharma) companies would need up to eight years to find new CDMO partners without disrupting the drug development process if a law is passed that prohibits US biopharmas from doing business with WuXi AppTec. Three months ago, BIO forced WuXi AppTec out of its organization, based on undisclosed information that the company had stolen IP from its clientele. BIO decided to conduct a survey that measured how deeply WuXi is involved with western biopharmas, and the answer is clear: very deep indeed. 

Company News

Shanghai Ribobay Pharma has built a cGMP-level oligonucleotide manufacturing center using Cytiva's first FlexFactory platform for oligo manufacturing (see story). Ribobay, a spin-off of General Biol (Anhui), said the facility will be ready to start manufacturing oligo in June, with the ability to produce several hundred kilograms of pharmaceutical oligo per year. Cytiva, headquartered near Boston, is a division of Danaher. Cytiva’s FlexFactory offers one-stop integrated services, from factory design to equipment and technologies that enable cGMP manufacturing. 

Trials and Approvals

Innovent Biologics (HK: 01801) reported Phase III results for mazdutide, its GLP-1/GCGR dual therapy for type 2 diabetes and weight loss, showing the candidate showed better efficacy for glycemic control than dulaglutide, Lilly’s Trulicity, a single GLP-1 agonist (see story). Mazdutide also showed multiple cardiometabolic benefits in T2D patients including weight loss. The trial was designed to test non-inferiority, but once non-inferiority was achieved, further testing for superiority was conducted.  Innovent acquired China rights to mazdutide from Lilly in 2019. 

Seoul’s HanAll Biopharma (KRX: 009420) has started a US Phase III trial to evaluate the efficacy of tanfanercept, a novel topical anti-inflammatory therapy for moderate to severe dry eye disease (DED) (see story). HanAll says tanfanercept has the potential to be a first-in-class topical anti-inflammatory treatment that targets tumor necrosis factor (TNF). TNF, a major cytokine, mediates DED inflammation. Tanfanercept is a molecularly engineered tumor necrosis factor receptor 1 (TNFR1) fragment with strong affinity for TNF and resistance to degradation by proteinases. 

Nanjing Leads Biolabs has been approved to begin a China Phase III trial of LBL-024, an anti-PD-L1/4-1BB bispecific antibody developed by Leads that will be tested in solid tumor cancers (see story). The single-arm pivotal study will examine the candidate for registration and market authorization by China’s CDE. LBL-024 is a bispecific antibody containing anti-programmed death ligand-1 and anti-4-1BB antibodies. Leads said the candidate binds to PD-L1 with high affinity, blocking the PD-L1/PD-1 immunosuppressive pathway while activating the 4-1BB costimulatory pathway in the tumor microenvironment. 

Shanghai NeuShen Therapeutics has dosed the first healthy patient in an Australian Phase I trial of its novel selective M4 receptor positive allosteric modulator (M4 PAM), a proposed therapy for schizophrenia (see story). NeuShen believes M4 PAM offers a novel approach to treating schizophrenia, with potential benefits in alleviating symptoms and cognitive impairment. In addition, the candidate may be able to treat psychosis in late-stage Alzheimer's disease or Parkinson's disease. NeuShen developed NS-136 from its proprietary small molecule R&D platform. In preclinical animal tests, the molecule showed efficacy against both positive and negative symptoms of schizophrenia. 

Guangzhou Bio-gene Technologies has started a China Phase I trial for an autologous CAR-T cell therapy that targets CLL-1, a member of the C-type lectin-like receptor family, in patients with relapsed/refractory acute myeloid leukemia (AML) (see story). BG1805 has already been studied in Investigator Initiated Studies, where it showed efficacy in both adults and children with blood malignancies and solid tumors. The BG1805 trial is the first of Bio-Gene’s CAR-T candidates to start formal clinical studies, although several have been tested in Investigator Initiated Trials. 

Suzhou’s Eluminex Biosciences was approved to start US trials of its novel trispecific fusion antibody aimed at treating diabetic macular edema (see story). EB-105 targets VEGF-A, VEGF-B, placental growth factor, angiopoetin-2, and interleukin-6 receptor. Eluminex believes that high levels of IL-6 may cause persistent refractory edema in DME patients who are currently being treated with existing drugs. The ability of EB-105 to inhibit several biological pathways simultaneously may offer better efficacy than present therapies, it added. Eluminex has raised over $100 million from investors including Lilly Asia Ventures, Quan Capital, Hillhouse Ventures, and Cenova Capital. 

Chengdu WestGene Biopharma will begin US trials of its Epstein-Barr (EB) virus-related mRNA therapeutic cancer vaccine, the first mRNA candidate approved to start trials for the indication (see story). The EB virus is correlated with more than ten malignancies. WestGene says WGc-043, its lead candidate, offers promising efficacy, low toxicity, broad applicability and efficient scalability at a cost-effective price. WGc-043 has already completed investigator-initiated trials in nasopharyngeal carcinoma and natural killer T-cell lymphoma, showing better safety and efficacy than other publicly available mRNA therapeutic cancer vaccines.