康方生物依沃西单抗胆道癌三期阳性结果获SCMP报道，属已处理催化的延迟媒体覆盖

Chinese biopharmaceutical firm Akeso announced on Wednesday that its immunotherapy drug had outperformed AstraZeneca’s Imfinzi in a head-to-head phase-three trial for biliary tract cancer. The result represents another breakthrough for Akeso’s ivonescimab – which has already been licensed by the US firm Summit Therapeutics in a multibillion-dollar deal – as China’s biopharma industry increasingly looks to compete on the global stage. The Chinese trial tested ivonescimab and chemotherapy against AstraZeneca’s Imfinzi (durvalumab) plus chemotherapy on a total of 682 patients with advanced biliary tract cancer – a particularly deadly form of cancer with a five-year survival rate of less than 5 per cent, according to a Nature study. The results showed that patients taking Akeso’s novel drug lived longer than those using the AstraZeneca treatment, the company said in a Hong Kong stock exchange filing released a day ahead of its interim results. The study marks the first positive phase-three study for ivonescimab in gastrointestinal tumours, potentially opening the door for the drug to be used in a “broader range of solid tumours”, said Xia Yu, Akeso’s founder, chairwoman and CEO. However, Akeso has yet to disclose the exact survival figures from the trial, which the Zhongshan-headquartered company is expected to present at an coming conference. Ivonescimab has already shown promise as a treatment for non-small cell lung cancer (NSCLC), receiving initial approval from Chinese regulators. The drug’s licenser, Summit, is also applying for approval to use ivonescimab to treat NSCLC in the United States. Akeso has launched a string of trials to test ivonescimab on other forms of cancer, including colorectal cancer and head and neck squamous cell carcinoma. The moves come as China’s biopharma firms increasingly look to compete directly against global giants such as AstraZeneca. The British-Swedish firm generated more than US$6 billion in revenue last year from sales of Imfinzi, up 28 per cent year on year. If things go smoothly, Akeso should be able to begin marketing ivonescimab as a treatment for biliary tract cancer in China relatively soon following the successful trial, according to analysts. “Typically, it takes about a year from a successful phase-three trial to market launch, once a company files its regulatory application for a specific indication,” said Zhang Jialin, head of China healthcare research at Nomura. But Tony Ren, head of Asia healthcare research at Macquarie Capital, cautioned that the trial would not necessarily open up a big new market for Akeso, as advanced biliary tract cancer was “a rare disease”. Akeso’s share price rose 5.96 per cent to HK$94.20 on Wednesday, outperforming the Hong Kong stock benchmark Hang Seng Index.