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.

Susan Galbraith, AstraZeneca EVP, oncology R&D, at EUBIO22 (Rachel Kiki for Endpoints News)

Up­dat­ed: As­traZeneca jumps deep­er in­to cell ther­a­py 2.0 space with $320M biotech M&A

Right from the start, the execs at Neogene had some lofty goals in mind when they decided to try their hand at a cell therapy that could tackle solid tumors.

Its founders have helped hone a new approach that would pack in multiple neoantigen targets to create a personalized TCR treatment that would not just make the leap from blood to solid tumors, but do it with durability. And they managed to make their way rapidly to the clinic, unveiling their first Phase I program for advanced tumors just last May.

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Tim Van Hauwermeiren, argenx CEO

Ar­genx pur­chas­es $100M+ FDA pri­or­i­ty re­view vouch­er from blue­bird bio

Argenx’s Vyvgart is due for a speedy review at the FDA, thanks to a $102 million priority review voucher (PRV).

The Netherland-based biotech picked up the PRV from bluebird bio, the companies announced on Wednesday. PRVs shorten a drug’s FDA review period from 10 months to 6 months, though they often sell on the open market for around $100 million each.

Argenx plans on using the express ticket on efgartigimod, its neonatal Fc receptor (FcRn) blocker marketed as Vyvgart for adults with generalized myasthenia gravis (gMG). While Vyvgart won its first approval last December for the chronic neuromuscular disease — which is characterized by difficulties with facial expression, speech, swallowing and breathing — CEO Tim Van Hauwermeiren said in a news release that he plans to “be active in fifteen disease targets by 2025.”

Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi and DN­Di aim to elim­i­nate sleep­ing sick­ness in Africa with promis­ing Ph II/III re­sults for new drug

The Drugs for Neglected Diseases initiative (DNDi) and Sanofi today said that their potential sleeping sickness treatment saw success rates of up to 95% from a Phase II/III study investigating the safety and efficacy of single-dose acoziborole.

The potentially transformative treatment for sleeping sickness would mainly be targeted at African countries, according to data published today in The Lancet Infectious Diseases medical journal. The clinical trial was led by DNDi and its partners in the Democratic Republic of the Congo (DRC) and Guinea, with the authors noting:

Lil­ly's Covid-19 mAb no longer au­tho­rized due to Omi­cron sub­vari­ants, FDA says

The FDA on Wednesday announced that Eli Lilly’s Covid-19 drug bebtelovimab is no longer authorized to treat Covid-19 because of the rising numbers of two new subvariants that the drug does not work against.

The Centers for Disease Control and Prevention last week published new estimates that the combined proportion of Covid-19 cases caused by the Omicron subvariants BQ.1 and BQ.1.1 are greater than 57% nationally, and already above 50% in all individual regions but one.

Uğur Şahin, BioNTech CEO (ddp images/Sipa USA/Sipa via AP Images)

BioN­Tech bets on dif­fi­cult STING field via small mol­e­cule pact with a Pol­ish biotech

BioNTech is beefing up its relatively thin small molecule pipeline by adding weight to a clinically difficult corner of oncology R&D: STING agonists. To do so, BioNTech is teaming up with a 15-year-old Polish biotech and doling out €40 million, about $41.5 million, to start.

The deal is broken into two parts: First, BioNTech obtains an exclusive global license to develop and market Ryvu Therapeutics’ STING agonist portfolio as small molecules, whether alone or in combination with other agents.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

Pharma advertisers on Twitter are done — at least for now. Ad spending among the previous top spenders flattened even further last week, according to the latest data from ad tracker Pathmatics, amid ongoing turmoil after billionaire boss Elon Musk’s takeover now one month ago.

Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

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Vi­a­tris with­draws ac­cel­er­at­ed ap­proval for top­i­cal an­timi­cro­bial 24 years lat­er

After 24 years without confirming clinical benefit, the FDA announced Tuesday morning that Viatris (formed via Mylan and Pfizer’s Upjohn) has decided to withdraw a topical antimicrobial agent, Sulfamylon (mafenide acetate), after the company said conducting a confirmatory study was not feasible.

Sulfamylon first won FDA’s accelerated nod in 1998 as a topical burn treatment, with the FDA noting that last December, Mylan told the agency that it wasn’t running the trial.

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Emily Leproust, Twist Bioscience CEO

Twist Bio­science’s 'fac­to­ry of the fu­ture' in Ore­gon could de­liv­er with com­pet­i­tive pric­ing, SVB Se­cu­ri­ties says

The synthetic DNA manufacturer Twist Bioscience has given a peek behind the curtain to several analysts into its “factory of the future” as well as insight into the cost structure, workflow and technology at the site.

The 110,000-square-foot manufacturing site in the city of Wilsonville, OR, just south of Portland, which was announced back in 2020, will double Twist’s production capacity and bring around 400 jobs to the area.