Recent Articles in Gov't & Regulatory

The US Securities and Exchange Committee warned three China biopharmas that their US-listed ADRs face delisting in three years time. The three companies, Beigene, Zai Lab and Hutchmed, were singled out because they have filed their 2021 annual reports to US regulators. Last year, the US passed a law requiring US-listed companies to submit their financial reports to a US auditor. That's a problem because China prohibits its companies from letting a foreign group audit their finances. The company have three years to solve the problem or they will be de-listed. More details....

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As predicted, a US FDA oncology advisory panel rejected the NDA submitted by Innovent and Lilly for their partnered anti-PD-1 antibody. Before the panel met, Lilly tried to influence the panel to approve the drug, sintilimab (Tyvyt), by announcing it would offer the drug at a wholesale price 40% lower than the US competition. The last-minute strategy didn't work: the panel voted 14-1 against approval. Yesterday, it seemed the main problem was the Phase III trial, which included only people with China genomes. But there were other issues as well. More details....

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The US FDA warned Innovent and Eli Lilly that their partnered PD-1 product, Tyvyt, will not be approved because the NDA is based only on China clinical trial data. Although the trial design is similar to previous trials, the participants were all China citizens -- no other ethnic groups were included. The FDA said it could not be sure Tyvyt would be as effective in US citizens or that it was more effective than therapies available in the US. The FDA's Oncology Committee will discuss the Tyvyt application for use with non-small cell lung cancer later this week. More details....

Stock Symbol: (HK: 01801) (NYSE: LLY)

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China is planning to regulate domestic technology companies that want to list on foreign exchanges. Since 1994, China-based companies could locate their official headquarters in places like the Cayman Islands to circumvent the rule that required China-headquartered companies to list only in mainland China. Many China biopharmas took advantage of the rules, with several of them now listed in two or three countries to raise more funds. These foreign IPOs did not previously require China's approval, but now they will. More details....

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