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.

Zhang Yi

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.

David Shao

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.

Qual­i­ty Con­trol in Cell and Gene Ther­a­py – What’s Re­al­ly at Stake?

In early 2021, Bluebird Bio was forced to suspend clinical trials of its gene therapy for sickle cell disease after two patients in the trial developed cancer. As company scientists rushed to assess whether there was any causal link between the therapy and the cancer cases, Bluebird’s stock value plummeted – as did those of multiple other biopharma companies developing similar therapies.

While investigations concluded that the gene therapy was unlikely to have caused cancer, investors and the public may be more skittish regarding the safety of gene and cell therapies after this episode. This recent example highlights how delicate the fields of cell and gene therapy remain today, even as they show great promise.

Brad Bolzon (Versant)

Ver­sant pulls the wraps off of near­ly $1B in 3 new funds out to build the next fleet of biotech star­tups. And this new gen­er­a­tion is built for speed

Brad Bolzon has an apology to offer by way of introducing a set of 3 new funds that together pack a $950 million wallop in new biotech creation and growth.

“I want to apologize,” says the Versant chairman and managing partner, laughing a little in the intro, “that we don’t have anything fancy or flashy to tell you about our new fund. Same team, around the same amount of capital, same investment strategy. If it ain’t broke, don’t fix it.”

But then there’s the flip side, where everything has changed. Or at least speeded into a relative blur. Here’s Bolzon:

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Law pro­fes­sors call for FDA to dis­close all safe­ty and ef­fi­ca­cy da­ta for drugs

Back in early 2018 when Scott Gottlieb led the FDA, there was a moment when the agency seemed poised to release redacted complete response letters and other previously undisclosed data. But that initiative never gained steam.

Now, a growing chorus of researchers are finding that a dearth of public data on clinical trials and pharmaceuticals means industry and the FDA cannot be held accountable, two law professors from Yale and New York University write in an article published Wednesday in the California Law Review.

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Novavax CEO Stanley Erck at the White House in 2020 (Andrew Harnik, AP Images)

As fears mount over J&J and As­traZeneca, No­vavax en­ters a shaky spot­light

As concerns rise around the J&J and AstraZeneca vaccines, global attention is increasingly turning to the little, 33-year-old, productless, bankruptcy-flirting biotech that could: Novavax.

In the now 16-month race to develop and deploy Covid-19 vaccines, Novavax has at times seemed like the pandemic’s most unsuspecting frontrunner and at times like an overhyped also-ran. Although they started the pandemic with only enough cash to last 6 months, they leveraged old connections and believers into $2 billion and emerged last summer with data experts said surpassed Pfizer and Moderna. They unveiled plans to quickly scale to 2 billion doses. Then they couldn’t even make enough material to run their US trial and watched four other companies beat them to the finish line.

FDA of­fers scathing re­view of Emer­gent plan­t's san­i­tary con­di­tions, em­ploy­ee train­ing af­ter halt­ing pro­duc­tion

The FDA wrapped up its inspection of Emergent’s troubled vaccine manufacturing plant in Baltimore on Tuesday, after halting production there on Monday. By Wednesday morning, the agency already released a series of scathing observations on the cross contamination, sanitary issues and lack of staff training that caused the contract manufacturer to dispose of millions of AstraZeneca and J&J vaccine doses.

Jenny Rooke (Genoa Ventures)

Ear­ly Zymer­gen in­vestor Jen­ny Rooke re­flects on 'chimeras' in biotech, what it takes to spot a $500M gem

When Jenny Rooke first heard of Zymergen back in 2014, she knew she was looking at something different and exciting. The Emeryville, CA biotech held the promise of blending biology and technology to solve a huge unmet need for cost-effective chemicals — of all things — and a stellar founding team to boot.

But back then, West Coast venture capitalists didn’t see in Zymergen the one thing they were looking for in a winning biotech: therapeutic potential. Rooke, however, saw an opportunity and made her bets. Seven years later, that bet is paying off in a big way.

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Saurabh Saha at Endpoints News' #BIO19

On the heels of $250M launch, Centes­sa barges ahead with an IPO to fu­el its 10-in-1 Medicxi pipeline

Francesco De Rubertis made no secret of IPO plans for Centessa, his 10-in-1 legacy play. Barely two months later, the S-1 is in.

The hot-off-the-press filing depicts the same grand vision that the longtime VC touted when he did the rounds in February: Take the asset-centric mindset that he’s been preaching at Medicxi over the years, and roll up a bunch of biotech upstarts, with unrelated risk profiles, into 1 pharma company that can carry on the development at scale.

Sen. Patty Murray (D-WA) (Graeme Sloan/Sipa USA/Sipa via AP Images)

Sen­a­tors to NIH: Do more to pro­tect US bio­med­ical re­search from for­eign in­flu­ence

Although Thursday’s Senate health committee hearing was focused on how foreign countries and adversaries might be trying to steal or negatively influence biomedical research in the US, the only country mentioned by the senators and expert witnesses was China.

Committee chair Patty Murray (D-WA) made clear in her opening remarks that the US cannot “let the few instances of bad actors” overshadow the hard work of the many immigrant researchers in the US, many of which have won Nobel prizes for their work. But she also said, “There is more the NIH can be doing here.”

Steffen Schuster, ITM CEO

Ra­dio­phar­ma re­mains hot as Ger­many's ITM rais­es $109M to ad­vance neu­roen­docrine can­cer pro­gram

The world of radiopharmaceuticals has been heating up over the last few years, and Thursday saw another company focused on the field pull in a new nine-figure raise.

Germany’s ITM, or Isotopen Technologien München, scored a $109 million round of loan financing to push forward its precision oncology pipeline and fund late-stage development for its lead program. As part of the agreement, the loan will convert to shares in the event of future financial or corporate transactions, ITM said.