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Mabwell’s Nectin-4 ADC Shows Efficacy in Triple-Negative Breast Cancer
May 13, 2024

Shanghai Mabwell reported positive data from a China trial of its novel Nectin-4-targeting ADC for triple-negative breast cancer. In 20 patients with advanced or metastatic disease, 50% reported an objective response and 80% experienced disease control. One patient had a complete response that has continued for 20 months so far. Mabwell says a China IND for the drug, 9MW2821, has also been accepted in combination with an immune checkpoint inhibitor. According to the company, 9MW2821 is the first the Nectin-4-targeting ADC developed by a Chinese company to start clinical trials. More details....

Stock Symbol: (SHA: 688062)

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Week in Review: Week in Review: Sciwind, Sino Biological and Biocytogen Announce Deals
May 11, 2024

Deals and Financings

  • Hangzhou Sciwind out-licensed Korean rights for its GLP-1 analog aimed at type 2 diabetes and obesity to HK inno.N in a deal that includes $56 million in potential milestones;
  • Beijing’s Sino Biological, a reagents/contract research services company, completed its $48 million acquisition of Vancouver’s SignalChem Biotech, an enzyme company;
  • Beijing’s Biocytogen signed a TCR-mimic antibody evaluation and potential licensing agreement with BioCopy AG of Basel, Switzerland;

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) and would need up to eight years to find new CDMO partners;

Company News

  • Shanghai Ribobay Pharma has built a cGMP-level oligonucleotide manufacturing center using Cytiva's first FlexFactory platform for oligo manufacturing;

Trials and Approvals

  • Innovent Biologics reported positive Phase III results for mazdutide, its GLP-1/GCGR dual therapy for type 2 diabetes and weight loss that outperformed single therapies;
  • Seoul’s HanAll Biopharma has started a US Phase III trial to evaluate the efficacy of tanfanercept, a novel topical anti-inflammatory therapy for dry eye disease;
  • Nanjing Leads Biolabs has been approved to begin a China Phase III trial of an anti-PD-L1/4-1BB bispecific antibody developed by Leads aimed at solid tumor cancers;
  • Shanghai NeuShen Therapeutics has dosed the first healthy patient in an Australian Phase I trial of its novel selective M4 receptor positive allosteric modulator for schizophrenia;
  • Guangzhou Bio-gene Technologies started a China Phase I trial for an autologous CAR-T cell therapy that targets CLL-1 for relapsed/refractory acute myeloid leukemia;
  • Suzhou’s Eluminex Biosciences was approved to start US trials of its novel trispecific fusion antibody aimed at treating diabetic macular edema;
  • Chengdu WestGene Biopharma will begin US trials of its Epstein-Barr (EB) virus-related mRNA therapeutic cancer vaccine, the first mRNA clinical stage candidate for cancer.

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Ribobay Builds Shanghai Oligonucleotide Plant using Cytiva’s FlexFactory
May 10, 2024

Shanghai Ribobay Pharma has built a cGMP-level oligonucleotide manufacturing center using Cytiva's first FlexFactory platform for oligo manufacturing. 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. More details....

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WestGene to Start US Trials of EB Virus-Related mRNA Therapeutic Cancer Vaccine
May 10, 2024

Chengdu WestGene Biopharma was approved to start US trials of its Epstein-Barr (EB) virus-related mRNA therapeutic cancer vaccine, the first mRNA candidate approved to start trials for the indication. 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. More details.....

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BIO Survey: 74% of Western Biopharmas Would Be Affected by WuXi AppTec Ban
May 9, 2024

BIO, the US-based biopharma trade association, reported that 74% of respondents to a survey have business with China CDMOs (mostly WuXi AppTec). 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. More details....

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