Competition in the fast-growing but increasingly crowded cancer immunotherapy market is heating up, with Shanghai-based CStone Pharmaceuticals aiming to seek approval by the year-end to market its drug for lung cancer – China's top oncology category. The company said that its Sugemalimab treatment was largely effective in the phase three clinical trial and could become the first drug of its kind in China to be to approved for non-small cell lung cancer (NSCLC). The study involving 480 stage-four lung cancer patients, showed it was able to reduce the risk of disease progression or death by half, compared to those receiving standard therapies. “It also has the potential to become the world’s first PD-L1 combined with chemotherapy to be approved simultaneously for treating both squamous and non-squamous NSCLC,” Frank Jiang Ningjun, chairman of the Hong Kong-listed firm, said in an interview on Wednesday. Squamous tumours, typically found in one of the bronchi, accounts for 30 per cent of all lung cancer cases. NSCLC is the dominant form of lung cancer in China. PD-1 is a protein on the surface of immune cells called T cells. PD-L1 is a protein on some cancer cells. When PD-1 binds to PD-L1, it signals T cells to leave the cancer cells alone, allowing them to avoid being attacked. Antibodies that target either PD-1 or PD-L1 can block this binding and boost the body’s immune response against cancer cells. They typically can work on multiple types of cancers. China recorded some 774,000 new lung cancer cases in 2018, almost one-fifth of all cancer cases in the nation, followed by colon, stomach, liver and breast cancers. Some 690,000 lung cancer patients died that year, a quarter of all cancer deaths. “The market space for anti PD-1 or PD-L1 drugs is very large, with estimates of annual revenue ranging from 40 billion yuan (US$5.8 billion) to well over 80 billion yuan within the next decade,” said Jay Lee, a Morningstar Investment Management analyst. “ However, it is likely to become very crowded, with at least eight PD-1 or PD-L1 inhibitors approved already, and many others in late stage clinical development.” The advent of these drugs means 15 to 20 per cent of cancer patients can be “cured”, with the rest expected to suffer from relapses after chemo and targeted therapies, CStone’s Jiang said. Drug companies are conducting trials that combine them with immunotherapies to extend lives. US-based Merck’s Keytruda was the first anti PD-1 therapy approved in China in combination with chemotherapy for first line lung cancer treatment last November. This allowed Merck to enjoy “first-mover” advantage, which means domestic followers will primarily compete on price and sales networks, Morningstar’s Lee said. Junshi Biosciences’ Toripalimab, the cheapest PD-1 available in China, costs about 100,000 yuan based on patient assistance programme prices, compared to about 300,000 yuan for Keytruda, according to trade media fiercepharma.com . “China’s PD-L1 market is already becoming crowded, with Merck, AstraZeneca, Bristol Myers Squibb, and Jiangsu Hengrui Medicine approved for NSCLC … Sino Biopharmaceutical will join the game very soon,” said Citi’s head of China health care research Cui Cui. “At this time, Keytruda from Merck has the best clinical data for lung cancer.”