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Government and Regulatory 

China regulators may be agreeable to a work-around that would prevent the de-listing of China companies from US stock exchanges, according to a Financial Times article (see story). A new US law demands China-based companies with US listings must have their financial reports reviewed by a US auditor.

The problem is Article 177 of China's security law, which prohibits foreigners from examining the inner workings of Chinese companies. However, the purpose of Article 177 is to prevent IP theft and protect national security. If Article 177 was defined more narrowly, information that pertains to China's concerns could be restricted, while allowing US auditors access to a company's financial details. 

I-Mab (IMAB), a Shanghai biopharma, said it expects China will work out an agreement with the US allowing US auditors to review the financial reports of China-based companies (see story).

Last week, three China biopharmas with dual listings -- BeiGene, Zai Lab, and Hutchmed -- were told they may face delisting unless a US-approved auditor reviews their financial records within three years. I-Mab, which is listed only in the US, also said it plans to IPO on the Hong Kong Exchange as a back-up plan.  

Deals and Financings

• Suzhou MediLink Therapeutics completed a $70 million Series B financing to develop its portfolio of novel ADC products and discover additional candidates (see story). One year ago, it completed a $50 million initial funding. Established in 2020, Medilink has patented several novel proprietary ADC linker-payload technologies and plans to start trials in China and the US this year. It has already formed partnerships based on its proprietary technology platform. The B round was led by LYFE Capital and Qiming Venture Partners, with co-investors Legend Capital, Loyal Valley Capital and Highlight Capital.  
• Impact Therapeutics, a Shanghai biopharma, closed a Series D1 funding of undisclosed size to develop its anti-oncology molecules (see story). Impact's portfolio is based on a synthetic lethality technology that it uses to generate novel DNA damage response (DDR) candidates. Synthetic lethality occurs when a mutation in two genes causes cell death, but a mutation in either gene alone does not. In 2020, Impact formed a JV with Junshi Pharma for its lead candidate, a PARP inhibitor. Junshi invested $50 million In the JV for a 50% share.  
• Simcere (2096.HK), a Nanjing biopharma, acquired China commercialization rights to a selective JAK1 inhibitor from Lynk Pharma of Hangzhou (see story). Simcere will market LNK01001 to patients with rheumatoid arthritis and ankylosing spondylitis. Lynk will continue to be responsible for clinical development of the candidate, while Simcere will make unspecified payments to acquire the rights. Earlier this year, Lynk started a double-blind, placebo-controlled China Phase II trial of LNK01001 for ankylosing spondylitis. In head-to-head clinical studies, JAK1 inhibitors have shown advantages over existing rheumatoid arthritis treatments, according to Lynk.  
• Beijing EdiGene signed a non-exclusive, worldwide license agreement to use IP developed by Boston Children's Hospital for increasing fetal hemoglobin levels (see story). The IP is related to methods and compositions for disrupting BCL11A expression at the genomic level. According to EdiGene, scientific evidence suggests that up-regulating the production of fetal hemoglobin is one way to address genetically caused hemoglobin diseases. EdiGene translates gene-editing technologies into novel therapies for genetic diseases and cancer. The terms of the agreement were not disclosed.  

Covid-19 Pandemic 

Five China pharmas have signed up in a global effort to manufacture a generic version of Pfizer's (PFE) oral COVID-19 treatment, nirmatrelvir, for use in 95 low and middle-income countries (see story).

The five China companies are part of a 35 member group formed by Medicines Patent Pool to manufacture and deliver the drug in low resource areas. Pfizer signed a licensing agreement with MPP to provide the drug to the countries, which represent 54% of the world's population. China is not included in the list of low income countries.

Trials and Approvals 

• Shanghai Junshi Bio's (1877.HK) anti-PD-1 met its endpoints in a US Phase III trial for NSCLC (see story). The double-blind Phase III trial tested toripalimab plus chemotherapy as a first-line therapy for non-small cell lung cancer. Compared to chemotherapy alone, the combination therapy showed clinically meaningful improvement in progression-free survival and overall survival. Last year, Junshi and its US partner, Coherus BioSciences (CHRS) of Redwood City, filed for US approval of toripalimab as a first-line treatment for advanced nasopharyngeal carcinoma.  
• Shanghai Junshi Bio has also dosed the first patient in an international Phase III trial of VV116 to treat moderate to severe COVID-19 (see story). VV116 is a novel oral nucleoside analog anti-SARS-CoV-2 drug designed to inhibit replication of SARS-CoV-2. The candidate was developed by a number of China Institutes, an Uzbekistan institute, Suzhou Vigonvita Life Sciences and Junshi. In preclinical studies, the drug showed antiviral activity against the original SARS-CoV-2 strain and all variants to date. It was approved for use in Uzbekistan last year.
• Nanjing Bioheng Biotech was approved to start China clinical trials of a universal CAR-T therapy, the first universal CAR-T green-lighted for human tests (see story). CTA101 targets CD19 and CD22 as a proposed treatment for adults with recurrent or refractory B-cell acute lymphoblastic leukemia. Founded in 2017, Bioheng specializes in developing allogeneic off-the-shelf cellular immunotherapies. Universal CAR-T cell therapies are expected to mainstream CAR-T technology by addressing the issues of high cost, long waiting time and difficult manufacturing compared to the original autologous CAR-T therapies.