With a big cash as­sist from lo­cal of­fi­cials, BeiGene is build­ing a $330M bi­o­log­ics fa­cil­i­ty in Chi­na

Xi­aodong Wang, BeiGene

In the lat­est sign that Chi­na’s biotech in­dus­try is de­vel­op­ing at high speed, one of its most promi­nent biotechs is prepar­ing to break dirt on a $330 mil­lion bi­o­log­ics man­u­fac­tur­ing cen­ter in Guangzhou which will al­so pro­vide some di­rect sup­port for R&D ac­tiv­i­ties.

BeiGene struck a deal to build the fa­cil­i­ty in part­ner­ship with lo­cal de­vel­op­ment of­fi­cials who are kick­ing in close to half of the mon­ey. The biotech will part­ner with Guangzhou GET Tech­nol­o­gy De­vel­op­ment Co., which is con­tribut­ing $150 mil­lion in cash and con­vert­ible loans for the joint ven­ture. BeiGene will pro­vide $30 mil­lion of the cost and the rest will be cov­ered by loans.

Ac­cord­ing to the an­nounce­ment, the JV plans to fi­nance clin­i­cal-stage drug R&D as well.

“This joint ven­ture will en­able BeiGene to keep pace with a grow­ing de­mand for the de­vel­op­ment and use of bi­o­log­ics in Chi­na and glob­al mar­kets,” com­ment­ed Xi­aodong Wang, the co-founder and chair­man of the sci­en­tif­ic ad­vi­so­ry board of BeiGene.

BeiGene, trad­ing on Nas­daq as {BGNE}, has been grow­ing fast, with a spe­cial fo­cus on on­col­o­gy, a big field in Chi­na. The biotech has built a staff of more than 200 work­ing on four can­cer ther­a­pies. The lead drug is a BTK in­hibitor now in the clin­ic, with a PD-1 drug com­ing up be­hind, along with a PARP in­hibitor. And it’s work­ing in part­ner­ship with Mer­ck KGaA.

The Chi­nese gov­ern­ment is play­ing a big role in fos­ter­ing its biotechs. Chi-Med, which has a re­search staff based in Shang­hai, has been get­ting a gov­ern­ment sub­sidy to help pay for the work it’s do­ing on new can­cer drugs, ac­cord­ing to CEO Chris­t­ian Hogg. And Chi-Med is now prep­ping its first new drug ap­pli­ca­tion to Chi­na’s FDA, test­ing the coun­try’s com­mit­ment to fos­ter­ing more home-grown ther­a­pies.

Guangzhou of­fi­cials sound like they’re all in, hop­ing to see their biotech hub near Hong Kong grow around this new project.

“We at­tach great im­por­tance to this project and be­lieve that the suc­cess­ful in­tro­duc­tion of BeiGene Bi­o­log­ics will trans­form Guangzhou De­vel­op­ment Dis­trict in­to a cen­ter for the in­no­v­a­tive bio­phar­ma­ceu­ti­cal in­dus­try, pro­mote the de­vel­op­ment of the biotech­nol­o­gy in­dus­try in the re­gion, and pro­vide a pow­er­ful dri­ving force for eco­nom­ic trans­for­ma­tion and up­grade. The gov­ern­ment will pro­vide strong sup­port in fund­ing, man­age­ment ser­vice, and cre­at­ing a good busi­ness en­vi­ron­ment,” com­ment­ed the ad­min­is­tra­tive com­mit­tee of Guangzhou Mu­nic­i­pal Gov­ern­ment and Guangzhou De­vel­op­ment Dis­trict.

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

FDA commissioner Stephen Hahn at the White House (AP Images)

Un­der fire, FDA to is­sue stricter guid­ance for Covid-19 vac­cine EUA this week — re­port

The FDA has been insisting for months that a Covid-19 vaccine had to be at least 50% effective – a measure of transparency meant to shore public trust in the agency and in a vaccine that had been brought forward at record speed and record political pressure. But now, with concerns of a Trump-driven authorization arriving before the election, the agency may be raising the bar.

The FDA is set to release new guidance that would raise safety and efficacy requirements for a vaccine EUA above earlier guidance and above the criteria used for convalescent plasma or hydroxychloroquine, The Washington Post reported. Experts say this significantly lowers the odds of an approval before the election on November 3, which Trump has promised despite vocal concerns from public health officials.

#ES­MO20: Push­ing in­to front­line, Mer­ck and Bris­tol My­ers duke it out with new slate of GI can­cer da­ta

Having worked in parallel for years to move their respective PD-1 inhibitors up to the first-line treatment of gastrointestinal cancers, Merck and Bristol Myers Squibb finally have the data at ESMO for a showdown.

Comparing KEYNOTE-590 and CheckMate-649, of course, comes with the usual caveats. But a side-by-side look at the overall survival numbers also offer some perspective on a new frontier for the reigning checkpoint rivals, both of whom are claiming to have achieved a first.

Samit Hirawat (Bristol Myers Squibb)

Af­ter bruis­ing re­jec­tion, blue­bird and Bris­tol My­ers Squibb land ide-cel pri­or­i­ty re­view. But will it mat­ter for the CVR?

With the clock all but up, the FDA accepted and handed priority review to Bristol Myers Squibb and bluebird bio’s BCMA CAR-T, keeping a narrow window open for Celgene investors to still cash in on the $9 CVR from the $63 billion Celgene merger.

The acceptance comes five months after the two companies weres slammed with a surprise refuse-to-file that threatened to foreclose the CVR entirely. Today’s acceptance sets the FDA decision date for March 27, 2021 – or precisely 4 days before the CVR deadline of March 31. Given the breakthrough designation and strong pivotal data — 81.5% response rate, 35.2% complete response rate — priority review was largely expected.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,400+ biopharma pros reading Endpoints daily — and it's free.

Zai Lab hauls in $761M from Hong Kong IPO to push Ze­ju­la, more bud­ding can­di­dates in Chi­na — re­port

Zai Lab is set to net more than $761 million from its secondary listing in Hong Kong after pricing the IPO at $72.51 (HKD$562) — just a hair below its Nasdaq closing price on Monday, Bloomberg and Nikkei Asian Review reported.

A pioneer in bringing Western drugs to China, co-founder and CEO Samantha Du has more than tripled Zai Lab’s market cap in the three years it’s been public in the US. The HKEX listing is designed to fund R&D and commercialization for the current portfolio while fueling new in-licensing pacts, the biotech wrote in a filing.

Tae Han Kim, Samsung Biologics CEO (SeongJoon Cho/Bloomberg via Getty Images)

Sam­sung Bi­o­log­ics nets $330M+ deal from As­traZeneca ahead of 'Su­per Plan­t' con­struc­tion

Just a few weeks after announcing plans to construct a $2 billion “Super Plant,” Samsung Biologics is keeping its foot on the gas.

The Korean CDMO has inked a $330.8 million manufacturing contract with AstraZeneca, the companies announced Monday evening, providing the British drugmaker the ability to expand production capabilities in the Asia market. Per terms of the deal, the partnership could be increased to $545.6 million.

Blueprint CEO Jeff Albers (file photo)

Blue­print plots re­turn to FDA with new Ay­vak­it da­ta in rare con­di­tion — and the an­a­lysts cheer

Over a decade after launch, Blueprint Medicines nabbed the first approval for their first drug earlier this year. Now, as they move forward with a Roche-partnered global launch, they’re touting data that could push them into more patients.

The Jeff Albers-led Cambridge biotech released their full pivotal data for Ayvakit in patients with advanced systemic mastocytosis. In one 53-person study, they showed that 76% of patients responded to the drug, 36% had complete responses and that on average their responses lasted for just over 3 years. A smaller, 32-patient study had a 75% response rate and most were still responding after 10.4 months, the last follow-up.

President Donald Trump (via AP Images)

Signs of an 'Oc­to­ber Vac­cine Sur­prise' alarm ca­reer sci­en­tists. HHS con­tin­ues to claim Azar “will de­fer com­plete­ly to the FDA"

President Donald Trump, who seems intent on announcing a Covid-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the FDA and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Trump — who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA — will take matters into his own hands, running roughshod over the usual regulatory process.