Review of the week: a possible solution to the American delisting of Chinese biopharmacies?

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Government and regulation

Chinese regulators may agree to a workaround that would prevent Chinese companies from being delisted from US stock exchanges, according to a Financial Times article (see article). A new US law requires companies based in China and listed in the US to have their financial reports reviewed by a US auditor. At issue is Article 177 of China’s Security Law, which prohibits foreigners from examining the internal workings of Chinese companies. However, the purpose of Section 177 is to prevent intellectual property theft and protect national security. If Section 177 were defined more narrowly, information about China’s concerns could be restricted, while allowing US auditors access to a company’s financial details.

I-Mab (IMAB), a Shanghai biopharmaceutical company, said it expects China to reach an agreement with the United States allowing American auditors to examine the financial reports of China-based companies ( see the article). Last week, three dual-listed Chinese biopharmaceutical companies – BeiGene, Zai Lab and Hutchmed – were told they were at risk of being delisted unless a US-certified auditor reviews their filings. financial within three years. I-Mab, which is only listed in the United States, also said it plans to go public on the Hong Kong Stock Exchange as a backup plan.

Offers and Financing

Suzhou MediLink Therapeutics has closed a $70 million Series B financing to grow its pipeline of new ADC products and discover other candidates. A year ago, it completed initial funding of $50 million. Founded in 2020, Medilink has patented several new proprietary ADC link payload technologies and plans to begin trials in China and the United States this year. It has already forged partnerships based on its proprietary technology platform. Round B was led by LYFE Capital and Qiming Venture Partners, with co-investors Legend Capital, Loyal Valley Capital and Highlight Capital.

Impact Therapeutics, a Shanghai biopharmaceutical company, has closed a Series D1 funding of an undisclosed size to develop its anti-oncology molecules. Impact’s portfolio is based on synthetic lethality technology which it uses to generate novel DNA damage response (DDR) candidates. Synthetic lethality occurs when a mutation in two genes causes cell death, but not a mutation in either gene. In 2020, Impact formed a joint venture with Junshi Pharma for its lead candidate, a PARP inhibitor. Junshi invested $50 million in the joint venture for a 50% share.

Simcere (HK:2096), a biopharmaceutical company from Nanjing, has acquired the rights to commercialize a selective JAK1 inhibitor in China from Lynk Pharma of Hangzhou. Simcere will market LNK01001 to patients with rheumatoid arthritis and ankylosing spondylitis. Lynk will continue to be responsible for the clinical development of the candidate, while Simcere will make unspecified payments to acquire the rights. Earlier this year, Lynk launched a double-blind, placebo-controlled Phase II trial in China of LNK01001 for ankylosing spondylitis. In head-to-head clinical studies, JAK1 inhibitors have shown benefits over existing treatments for rheumatoid arthritis, according to Lynk.

Beijing EdiGene has signed a non-exclusive worldwide license agreement to use intellectual property developed by Boston Children’s Hospital to increase fetal hemoglobin levels. The IP relates to methods and compositions for disrupting BCL11A expression at the genomic level. According to EdiGene, scientific evidence suggests that up-regulating fetal hemoglobin production is a way to combat genetically-caused hemoglobin diseases. EdiGene translates gene editing technologies into new therapies for genetic diseases and cancer. Terms of the contract were not disclosed.

Covid-19 pandemic

Five Chinese pharmaceutical companies have embarked on a global effort to manufacture a generic version of Pfizer’s oral COVID-19 treatment, nirmatrelvir, for use in 95 low- and middle-income countries (see story). The five Chinese companies are part of a 35-member group formed by Medicines Patent Pool to manufacture and deliver the drug to low-resource areas. Pfizer has signed a license agreement with the MPP to supply the drug to countries, which represent 54% of the world’s population. China is not on the list of low-income countries.

Tests and approvals

Shanghai Junshi Bio’s anti-PD-1 (HK: 1877; SHA: 688180) met endpoints in a US Phase III trial for NSCLC. The double-blind phase III trial tested toripalimab plus chemotherapy as a first-line treatment for non-small cell lung cancer. Compared to chemotherapy alone, combination therapy showed clinically significant improvement in progression-free survival and overall survival. Last year, Junshi and his 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 (HK: 1877; SHA: 688180) has administered the first patient in an international Phase III trial of VV116 to treat moderate to severe COVID-19. VV116 is a novel anti-SARS-CoV-2 oral nucleoside analogue drug designed to inhibit SARS-CoV-2 replication. The candidate was developed by a number of Chinese institutes, an Uzbek institute, Suzhou Vigonvita Life Sciences and Junshi. In preclinical studies, the drug showed antiviral activity against the original strain of SARS-CoV-2 and all variants to date. It was approved for use in Uzbekistan last year.

Nanjing Bioheng Biotech has received approval to begin clinical trials in China of a universal CAR-T therapy, the first universal CAR-T to be given the green light for human testing. CTA101 targets CD19 and CD22 as a proposed treatment for adults with relapsed or refractory B-cell acute lymphoblastic leukemia. Founded in 2017, Bioheng specializes in the development of ready-to-use allogeneic cellular immunotherapies. Universal CAR-T cell therapies should generalize CAR-T technology by solving the problems of high cost, long waiting time and difficult manufacturing compared to the original autologous CAR-T therapies.

Disclosure: none.

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Editor’s note: The summary bullet points for this article were chosen by the Seeking Alpha editors.