Deals and Financings:

Moderna, the Boston mRNA vaccine company, signed a deal to set up operations in Shanghai that will develop and make mRNA products specifically for China’s market (see story). The company’s CEO, Stéphane Bancel, arrived in Shanghai this morning. Although the company confirmed an agreement has been signed, it did not disclose a monetary value to the new venture, even though multiple outlets said Moderna would invest up to $1 billion to establish a China presence. In May, the company allocated $100 million to open an office in Shanghai’s Minhang district. Moderna, the parent company, is developing a large portfolio of mRNA vaccines for conditions other than COVID, including common infections, HIV and several cancer vaccines. 

F-star Therapeutics (HK: 1177), a London invoX company, formed a collaboration and license agreement with Japan’s Takeda to develop Fcab domains aimed at undisclosed immuno-oncology targets (see story). F-star will use its proprietary fully-human Fcab™ and tetravalent mAb² platforms to identify and develop next-gen multi-specific immunotherapies. It will receive an undisclosed upfront payment, research funding and up to $1 billion in milestones from Takeda for several programs, plus royalties. F-star’s platform develops tetravalent (2+2) bispecific antibodies. invoX is the ex-China drug development arm of Sino Biopharm. 

Beijing Brii Bio (HK: 2137) signed an expanded global license to an HBV immunotherapeutic therapy developed by VBI Vaccines for $15 million in near-term payments plus $422 million in milestones (see story). VBI is also eligible for royalties. Brii originally acquired China rights to the vaccine soon after it was formed in 2018. Brii believes BRII-179 will become part of a combination therapy that causes a strong response, creating a functional cure for HBV. As part of the deal, Brii will also acquire rights from VBI to develop and commercialize a HBV prophylactic vaccine, PreHevbri®, in Greater China and Asia Pacific countries. 

Worg Pharmaceutical of Shanghai closed a $152 million Series C round to advance its portfolio of novel immunotherapies aimed at allergic and autoimmune diseases along with other indications that target unmet medical needs (see story). The company has two platforms: the PCFiT allergy platform, and the Apitopes platform for autoimmune diseases. In 2020, Worg bought Biomay, an Austrian company, acquiring its PCFiT platform. In 2021, Worg bought Apitopes, a Belgium company with its Apitopes platform candidates. The PCFit platform includes a Phase II candidate for grass pollen and four other allergy therapies. The Apitope platform consists of five assets, three of which have started clinical trials. 

Sirnaomics (HK: 2257), an RNAi company based in Suzhou, partnered with EDIRNA, an RNA editing startup, providing initial  to the startup along with rights to Sirnaomics’ proprietary delivery technologies for RNA editing therapies (see story). EDIRNA intends to use its proprietary Edit-to-Cure Therapeutics™ platform to find new cures for genetic disorders and cancers, with an initial focus on lung, liver, CNS (Parkinson’s) and ocular diseases. The company believes its technology addresses the cause of diseases, providing a safer alternative to permanent genetic editing approaches. EDIRNA is headquartered in Germantown, MD. 

Trials and Approvals

Shanghai Zai Lab (NSDQ: ZLAB; HK: 9688) was approved to launch Vyvgart® in China as an add-on to standard of care treatment for generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor antibody positive (see story). Vyvgart® (efgartigimod alfa injection) is a first-in-class neonatal Fc receptor (FcRn) antagonist. Two years ago, Zai acquired Vyvgart® from Amsterdam’s argenx SE (Euronext/NSDQ: ARGX) in a $175 million deal. Zai said it will now work with government officials to include the drug in China’s National Reimbursement Drug List. 

Suzhou Innovent (HK: 01801) and Nanjing’s IASO Bio were approved to launch their partnered BCMA CAR-T in China as a fourth-line therapy for multiple myeloma (see story). The drug, which will be launched with the name Fucaso® (equecabtagene autoleucel, is the first BCMA-directed CAR T cell therapy approved in China for adult patients with relapsed or refractory multiple myeloma (RRMM). Fucaso® uses a lentivirus as a gene vector to transfect autologous T cells and contains 4-1BB-mediated co-stimulation and CD3ζ activation domains. It produced a complete response in 74% of the trial patients. 

Skyline Therapeutics, a Shanghai-Boston gene therapy company, was cleared to start a US Phase I/IIa trial of SKG0106, a one-time intravitreally delivered AAV gene therapy for neovascular age-related macular degeneration (see story). The company develops candidates that address rare and severe diseases. Its expertise includes capsid discovery, vector engineering and design, in-vivo pharmacology, clinical development, analytical and process development along with CMC. Founded in 2019, Skyline has ten molecules in development. It plans to start a Global Phase I clinical trial of SKG0106 soon. 

Jiangsu Hansoh Pharma (HK: 3692) was approved to start China trials of HS-10518, a novel drug aimed at managing moderate to severe pain associated with endometriosis (see story). HS-10518 is an orally active non-peptide gonadotropin-releasing hormone (GnRH) antagonist for endometriosis and uterine fibroids. Hansoh believes the candidate will offer improved dosing convenience and a better safety profile than existing treatments. One year ago, Hansoh acquired China rights to the drug from South Korea’s TiumBio for $170 million plus tiered royalties on net sales. 

Disclosure: none.