China's YishengBio chronicles comeback story in Hong Kong IPO while plotting big moves in infectious diseases, cancer
It can be tough to be a vaccine developer in China.
YishengBio shed some light on the regulatory hoops and hurdles it had to jump through since launching its first rabies vaccine in 2003 — and the grand plans it has for the global pipeline in infectious diseases and cancer — in an IPO filing on the HKEX.
The 2014 dispute that founder and chairman Zhang Yi got into with the Chinese FDA, for instance, turned out to have cost a lot more than just a few vaccine batches that didn’t get released. While the company said it had voluntarily halted manufacturing activities, reported the contamination and began a review of the facilities, the regulators performed an inspection and suspended the GMP license for a couple of months while also blocking release of 117 other lots of the YSJA rabies vaccine. Attempts to take the then-CFDA to court ended in vain.
After the GMP license expired at the end of 2013, the lapse in manufacturing apparently stretched out over years:
We ceased the production of YSJA™ rabies vaccine in early 2014 when our five-year GMP certification expired. We received the GMP certificate of our newly constructed manufacturing facilities in Shenyang and launched the production of YSJA™ rabies vaccine in the new facilities in July 2019. We started the production of YSJA™ rabies vaccine in February 2020 and the sales and marketing since October 2020.
Fortunately for Yisheng though, 2013 was also the year when its PIKA technology — which it obtained by acquiring Singapore’s NewBiomed three years prior — was named a National Key Medical Innovation Project, receiving funding support for preclinical as well as Phase I and II research. It’s also raised $20 million from venture capitalists in a Series A featuring high-profile names such as OrbiMed and F-Prime.
Since then, Yisheng had built up a pipeline around PIKA, spanning a Phase III-ready next-gen rabies jab, HBV vaccines and treatments, cancer immunotherapies and, more recently, a Covid-19 shot now in preclinical studies.
According to the biotech, the technology “augments both innate and adaptive immune responses through the TLR3, RIG-I and MDA5 pathways.”
Under CEO David Shao, it’s also sold around 3.1 million doses of its commercial YSJA product to over 920 county-level CDCs in China.
The comeback culminated in a $130 million crossover round announced just days ago which, per the filing, gave it a post-money valuation of $815 million. Apart from OrbiMed and Oceanpine — the co-leaders — the Series B gave the biotech an enviable list of marquee investors: EightRoad, F-Prime Capital, 3W Capital, Hillhouse Capital, MSA Capital, AIHC, Epiphron Capital, Superstring Capital, Haitong International and Adjuvant Capital, a public health-minded crew with ties to the Gates Foundation.
Zhang, though, remained a controlling shareholder throughout all this. The founder group he and his wife Rui Mi lead holds 58.17% of the total issued shares, giving them substantial influence potentially even after the IPO.
Aside from a continued commercial push in China (and accompanying scale-ups in their base in Shenyang), he’s also eyeing manufacturing setups in Singapore to accommodate an expansion into Southeast Asia.