Hui Shao, YS Biopharma president and CEO (L) and Yi Zhang, founder and chairman

Chi­na’s Yisheng­Bio is go­ing to Nas­daq, mak­ing the tran­si­tion via $230M SPAC ma­neu­ver

Af­ter at­tempt­ing to make it on the HKEX last year, a Chi­nese bio­phar­ma is fi­nal­ly tak­ing the once-flashy SPAC route to get on the Nas­daq.

Yisheng­Bio — which will be re­named YS Bio­phar­ma, per a Thurs­day state­ment — will be com­bin­ing with Hong Kong-based Sum­mit Health­care Ac­qui­si­tion Corp, cur­rent­ly list­ed on Nas­daq un­der the tick­er $SMIH af­ter launch­ing on the stock ex­change last year. If every­thing goes to plan, the merg­er will be fin­ished in Q1 next year.

The fi­nanc­ing will be used to push the clin­i­cal de­vel­op­ment of two of YS’s main can­di­dates to the com­mer­cial­iza­tion stage in mul­ti­ple, yet undis­closed, mar­kets.

The trans­ac­tion puts YS Bio­phar­ma at a pre-mon­ey eq­ui­ty val­u­a­tion of $834 mil­lion. Af­ter the merg­er, YS said that it would earn close to $230 mil­lion in gross pro­ceeds — $30 mil­lion from a pri­vate place­ment and $200 mil­lion that is cur­rent­ly sit­ting in Sum­mit’s trust ac­count. Per an SEC fil­ing from Sum­mit, pri­vate in­vestors Snow Lake Cap­i­tal and the Al­liance Fund en­tered in­to agree­ments for $30 mil­lion as part of a pri­vate place­ment to be done as soon as Sum­mit and YS merge.

As for what the fi­nal tick­er will be, that has not been fi­nal­ized yet. The cur­rent ex­ec­u­tive team, which cur­rent­ly is helmed by pres­i­dent and CEO Hui Shao and founder and chair­man Yi Zhang, will con­tin­ue to lead the new com­pa­ny, a state­ment not­ed.

YS, which orig­i­nal­ly built it­self around its pre­vi­ous­ly-con­flict­ed, sig­na­ture YS­JA ra­bies vac­cine, has ex­pand­ed its pipeline to oth­er vac­cines and bi­o­log­ics. One of its main can­di­dates is an ad­ju­vant­ed ra­bies vac­cine cur­rent­ly on its way to Phase III clin­i­cal tri­als. Ad­di­tion­al­ly, YS is tout­ing a re­com­bi­nant Covid-19 vac­cine in Phase II/III tri­als on­go­ing in the UAE, the Philip­pines and Pak­istan.

Yisheng got it­self in­to con­flict with the Chi­nese health reg­u­la­tor, the NM­PA, over the YS­JA vac­cine, cost­ing the bio­phar­ma years of not be­ing able to pro­duce new batch­es. Af­ter its GMP li­cense ex­pired, it end­ed up wait­ing years be­fore get­ting it back on­line. Per a note, at the time it was at­tempt­ing to go pub­lic in Hong Kong:

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.

The mar­ket lull over the past cou­ple of months has made many po­ten­tial in­vestors and com­pa­nies shy of go­ing pub­lic — but not every­one. A SPAC re­cent­ly merged with small biotech Zu­ra Bio, which cur­rent­ly is in­ves­ti­gat­ing a Phase II mon­o­clon­al an­ti­body for alope­cia area­ta, an au­toim­mune con­di­tion char­ac­ter­ized by hair loss. That in­di­ca­tion just got its first ap­proved treat­ment a few months ago in Eli Lil­ly’s Olu­mi­ant.

Vac­cine doc­u­ments, young lead­ers and mar­ket tur­moil: End­points' 10 biggest sto­ries of 2022

It’s been a volatile year in the world of biopharma. Market declines reset M&A valuations, and may be beginning to tempt bigger buyers back into dealmaking. Russia’s war in Ukraine disrupted drug sales and clinical trials. A new generation of young biotech leaders emerged in the Endpoints 20(+1) Under 40. And as capital runs dry in a tough environment for raising new funds, companies big and small are taking a look at their headcounts and operations for ways to make it through lean times.

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Tom Riga, Spectrum Pharmaceuticals CEO

Spec­trum im­plodes af­ter a harsh pub­lic slap­down and now a CRL from Richard Paz­dur

The FDA has gone out of its way several times to flatten any expectations for Spectrum’s lung cancer drug poziotinib, including slamming the regulatory door in the biotech’s face four years ago when the their executive crew came calling for a breakthrough drug designation and encouragement from the oncology wing of the FDA.

That stinging early rebuke pointed straight down the path to a corrosive in-house agency review of Spectrum’s attempt to land an accelerated approval for the oral EGFR TKI and a public whipping that included a classic takedown by none other than Richard Pazdur, who slammed the company for “poor drug development” that led to confusion over the dose needed for a slice of NSCLC patients harboring HER2 exon 20 insertion mutations.

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Big Phar­ma's Twit­ter ex­o­dus; Mer­ck wa­gers $1.35B on buy­out; $3.5M gene ther­a­py; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

As you start planning for #JPM23, we hope you will consider joining Endpoints News for our live and virtual events. For those who are celebrating Thanksgiving, we hope you are enjoying the long weekend with loved ones. And if you’re not — we’ll see you next week!

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Albert Bourla, Pfizer CEO (John Thys/POOL/AFP via Getty Images)

Pfiz­er CEO un­der fire from UK watch­dog over vac­cine com­ments — re­port

Pfizer CEO Albert Bourla told the BBC last December that he had “no doubt in my mind that the benefits, completely, are in favor” of vaccinating 5- to 11-year-olds for Covid-19. Almost a year later, those comments have reportedly landed him in trouble with a UK pharma watchdog.

Children’s advocacy group UsForThem filed a complaint with the UK’s Prescription Medicines Code of Practice Authority (PMCPA) last year accusing Bourla of making “disgracefully misleading” statements during the BBC interview, including one that “Covid in schools is thriving.” At the time, UK regulators had not yet cleared the vaccine for the 5 to 11 age group, though the vaccine did have a positive opinion from the EMA’s human medicines committee.

Sanofi's new headquarters, La Maison Sanofi, in Paris (Credit: Luc Boegly)

Sanofi wel­comes 500 staffers to new Paris HQ af­ter €30M ren­o­va­tion

When Paul Hudson took the helm at Sanofi back in 2019, he promised to reinvent the pharma giant — including its Paris headquarters. This week, the company set up shop in new “state-of-the-art” digs.

La Maison Sanofi, as the new HQ is called, is officially open for business, Hudson announced on Monday. The 9,000-square-meter (just under 97,000-square-foot) space accommodates 500 employees across the company’s government and global support functions teams, including finance, HR, legal and corporate affairs — and it was built with environmental sustainability and hybrid work in mind.

Sta­da to place $50M+ in­vest­ment in a new fa­cil­i­ty in Ro­ma­nia

While Romania may conjure up images of vast mountain ranges and tales of medieval kings, one generic manufacturer has broken ground on a new facility there.

German pharma company Stada said Monday that it has placed a €50 million ($51.9 million) investment into a 100,000 square-meter (1.08 million square-foot) site in Turda, Romania, a city in the Southeast of the country. According to a Stada spokesperson in an email to Endpoints News, the company has developed only 281,500 square feet of the site so far.

Rachael Rollins (Charles Krupa/AP Images)

US seeks jail time for co-CEO of New Eng­land com­pound­ing cen­ter af­ter dead­ly 2012 fun­gal out­break

The US attorney for the district of Massachusetts late last week called on the state’s district court to sentence the former co-owner of the now-defunct New England Compounding Center to 18 months of jail time for his role in the center’s quality deviations that led to more than 100 people dead from a fungal meningitis outbreak.

Gregory Conigliaro was convicted of conspiring with more than a dozen others at NECC to deceive the FDA and misrepresent the fact that the center was only dispensing drugs pursuant to patient-specific prescriptions.

FDA tells Catal­ent to fix is­sues at two man­u­fac­tur­ing sites on its own

The CDMO Catalent will have to fix issues at two manufacturing plants in the US and Europe that were subject to inspections by the FDA this summer, giving the company room to correct the issues without facing further regulatory action.

The FDA gave Catalent a “voluntary action indicated” response to two inspections at the contract manufacturer’s site in Bloomington, IN, and Brussels, Belgium. Fixing the issues on its own is a preferable outcome to facing an “official action indicated” response, meaning that an official warning would be sent out or a sit-down with the FDA would be required.

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Merck targets vaccine-hesitant parents in its latest 'Why Vaccines' campaign. (Image: Shutterstock)

Mer­ck­'s lat­est 'Why Vac­ci­nes' cam­paign seeks to bet­ter in­form vac­cine-hes­i­tant moms

From Hollywood couple endorsements to targeted equity efforts, Merck has been pushing the value of vaccinations, especially since the Covid-19 pandemic disruption. Now the pharma is turning to a new target — vaccine-hesitant parents, and moms in particular.

Merck’s “Why Vaccines” latest social media and digital campaign spotlights real-life new moms who have questions about vaccinating their children.

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