A version of this digest first appeared in the weekly STAT China newsletter. To receive future editions, sign up here.
Good day and thanks for joining us this week for STAT China. Just as Chinese Covid-19 vaccine developers look to other countries to host their late-stage trials, a major global pharma in the vaccine race added a Chinese partner last week. The country also endorsed a CAR-T project, and another biotech is reportedly mulling a Hong Kong IPO later this year.
Simcere nabs rights to potential first-in-class cancer therapy
Nanjing drug manufacturer Simcere Pharma has partnered with G1 Therapeutics to commercialize its investigative cancer drug trilaciclib for the Chinese market.
Under the terms of the deal, Simcere will pay the North Carolina-based drug developer $14 million upfront and up to $156 million in development and commercial milestone payments in addition to royalties on trilaciclib sales in China. The company will also participate in future global trials for the drug.
Simcere has been pivoting toward a more innovative drug pipeline, and gaining the exclusive rights to G1’s trilaciclib certainly fits the bill. The neoadjuvant cancer treatment is designed to protect patients from chemotherapy-induced bone marrow damage known as myelosuppression.
There are more than three-quarters of a million new small cell lung cancer (SCLC) cases each year in China, and chemotherapy is the standard treatment, a G1 spokesman told STAT. “Our partnership with Simcere is across all indications, and we’re excited to work with them on clinical trials in other indications.”
In June, G1 filed a new drug application with the U.S. Food and Drug Administration for trilaciclib for treating SCLC and plans to launch a Phase 3 trial for colorectal cancer toward the end of the year, and another trial for metastatic triple-negative breast cancer in 2021.
Chinese vaccine manufacturer joins AstraZeneca’s global Covid-19 vaccine program
A Shenzhen-based Chinese vaccine maker has agreed to help manufacture AstraZeneca’s Covid-19 vaccine for China if it is approved by local regulators.
KangTai Biological Products, or BioKangtai, has partnered with the British drug developer to produce and commercialize its vaccine candidate AZD1222, originally developed by the University of Oxford. China is AstraZeneca’s second biggest market and contributes approximately one-fifth of its total revenue.
BioKangtai will manufacture at least 100 million doses of the vaccine by the end of this year and at least 200 million doses by the end of 2021, the statement said.
In June, AstraZeneca committed to producing 2 billion doses of its experimental Covid-19 vaccine. The company has struck deals to supply its vaccine in Europe and the U.S., and has partnered with the Serum Institute of India to provide 1 billion doses for low- and middle-income countries. Japan will also purchase 120 million doses from AstraZeneca, starting with 30 million doses by March next year, Reuters reported.
U.S. orders more domestic drug production to reduce reliance on China
President Trump signed an executive order last Thursday urging the U.S. federal government to source drug supplies and medical equipment from local providers amid heightened tensions with China, the world’s biggest supplier of active pharmaceutical ingredients.
“We will bring our pharmaceutical and medical supply chains home — we’re going to bring them home where they belong — and we will end reliance on China,” Trump said during a visit to a manufacturing plant in Ohio.
China is currently the world’s biggest supplier of a number of essential medicines. This includes 70% of the U.S. supply of acetaminophen, the common pain medication. The country also manufactures at least 80% of the global supply of anticoagulant heparin and antibiotics, industry experts estimated.
Legend Biotech lands CAR-T breakthrough designation under new CEO
China’s National Medical Products Administration and the Center for Drug Evaluation has granted Legend Biotech’s investigational CAR-T cell therapy its first breakthrough therapy designation, the company said.
The Chinese biotech, which recently listed on Nasdaq, is the first company to receive a breakthrough therapy status since the Chinese regulators published its first working draft procedures for reviewing breakthrough therapeutics last month. The designation is meant to speed up the approval of novel therapies that treat serious illnesses for which there is no treatment, with preliminary data showing they are better than existing options.
The NMPA’s breakthrough therapy designation for Legend’s ciltacabtagene autoleucel, or cilta-cel, is based on a number on ongoing Phase 1 and 2 studies of the CAR-T cell therapy in China, Japan, and the U.S. The company has been collaborating with Johnson & Johnson since 2017 on global commercialization of the BMCA-targeting cell therapy for treating patients with multiple myeloma.
Last weekend, Legend also announced that its CEO, Yuan Xu, has resigned for personal reasons. The company has appointed Frank Zhang, chairman of Legend’s board of directors and CEO of Genscript Biotech — the company it spun out of earlier this year — to be its new CEO.
Jacobio plans Hong Kong IPO
Beijing-based drug company Jacobio Pharma is eyeing an IPO on the Hong Kong stock exchange later this year, Bloomberg reported, citing people familiar with the situation.
The Chinese biotech could raise $400 million through the offering, sources said. The company was founded in 2015 and has focused on developing cancer therapies, drawing funding from top-tiered private equity investment companies such as Qiming Venture Partners, Hillhouse Capital, and Lilly Asia Ventures.
The global pandemic has not deterred investors from deploying capital toward health care IPOs. The Hong Kong Stock Exchange has seen a steady stream of biotech and health care companies going public this year, raising nearly $4.5 billion, which is almost as much as last year’s total, according to Bloomberg data.