China pushes two more Covid-19 vaccine trials, tests stem cell therapy

Chinese regulators have approved two new clinical trials for vaccine candidates for Covid-19. Both will use inactivated viruses.

Unlike vector-based vaccines — like the kind CanSino Biologics is developing for Covid-19 — inactivated vaccines use dead viruses or smaller parts of it to trigger an immune response in the body.

China National Pharmaceutical Group, more commonly known as Sinopharm, is developing one of these vaccine candidates through its subsidiary, Wuhan Institute of Biological Products. The state-owned drug manufacturer has allocated 1 billion yuan (roughly $140 million) for vaccine R&D, including the development of two other vaccines, Xinhua reported.

The second vaccine is being developed by Beijing-based Sinovac Biotech. The company's Phase 1/2 trial will evaluate the vaccine's safety and immunogenicity in 144 health adults, with two-thirds receiving the vaccine and the remaining volunteers receiving placebo.

Aside from vaccines, Chinese researchers have also been testing potential new treatments against the novel coronavirus, including a stem cell therapy that has been administered to more than 200 individuals in Wuhan.

Akeso Biopharma to launch IPO in Hong Kong this week

Chinese biotech Akeso Biopharma is finally set to go public on the Hong Kong Stock Exchange this week, after a rare regulatory filing gaffe led to its initial IPO application getting rejected in December last year.

The clinical stage manufacturer developing oncology and immunology drugs had to refile its application with the exchange because the first one had a typo that indicated its listing date in the second quarter instead of the first, sources familiar with the situation told the Financial Times. In hindsight, that typo could've save a lot of paperwork.

According to its regulatory filing, the Zhongshan-based company is expecting to raise about $300 million to fund its novel drug developmental programs, consisting of a portfolio of about 20 monospecific and bispecific antibodies. Its two lead compounds are PD-1-based molecules. AK104 is a PD-1/CTLA-4 bi-specific antibody, while AK105, or penpulimab, is being co-developed with Sino Biopharm as a monoclonal antibody. Both compounds are being developed to target multiple cancer types.

Shares are expected to start trading on Friday.

RemeGen's fusion protein gets fast-tracked by FDA for lupus

Shandong-based biotech RemeGen was granted a fast-track designation by the Food and Drug Administration for its investigational fusion protein, RC18, for the treatment of systemic lupus erythematosus (SLE).

Also known as telitacicept, RC18 is a recombinant protein that is being developed to treat autoimmune diseases. The drug only inhibits the development and survival of plasma cells and mature B cells, minimally affecting early and memory B cells, which are important for normal immune function.

In its latest Phase 2b trial readout last November, RC18 met its primary endpoint of a greater than 4-point reduction in the SLE Responder Index (SRI4) — a composite endpoint that assesses disease activity and response to treatment in SLE. Over 75% of patients showed clinically meaningful activity improvement compared to 34% with placebo.

Earlier this month, the company raised $100 million in a private funding round led by Lilly Asia Ventures and Lake Bleu Capital.
With one manufacturing site in Yantai, RemeGen told STAT said it may outsource some manufacturing to mitigate potential supply chain risks from Covid-19.

"We plan to combine our in-house manufacturing capacity with a third-party contract manufacturing organization to diversify the source/location of our global supply chain. At this time, the company has not experienced any material impact to its supply chain," the company said.

China's VC funding rallies after coronavirus lockdown lifted

Venture capital financing in China is back up sixfold from its February lows as investors hunt for bargain buys, including deals in biotech, the Financial Times reported, based on data from the Asian Venture Capital Journal.

Chinese startups and tech companies raised more than $2.5 billion in March, up from $410 million in February. With lower valuations as a result of the pandemic, funds are willing to deploy capital in companies with robust business models. Two weeks ago, Qiming Venture Partners raised over $1 billion for a venture fund that will focus on early stage health care and technology investments.