Tap­ping a biotech boom, Chi­na gene edit­ing CRO Bio­cy­to­gen bags $65M round for glob­al ex­pan­sion

Mon­ey is flow­ing in and out of Chi­na, and it’s touch­ing every part of the ecosys­tem. To­day, a Chi­nese CRO spe­cial­iz­ing in an­i­mal mod­els for gene edit­ing and tar­get­ing spread the word that it has reaped a $65 mil­lion Se­ries C round led by do­mes­tic in­vestors.

Bio­cy­to­gen says the pro­ceeds will go to­ward open­ing up mar­kets both in Chi­na and over­seas, prod­uct R&D, fa­cil­i­ty con­struc­tion and tal­ent re­cruit­ment. CMB In­ter­na­tion­al Cap­i­tal Cor­po­ra­tion, the fi­nan­cial arm of Chi­na Mer­chants Bank, led the round, with sup­port from ex­ist­ing in­vestors like SDIC Ven­ture Cap­i­tal Man­age­ment (Se­ries B lead), 3E Bioven­tures, Cowin Cap­i­tal and Oriza Hold­ings.

Yuelei Shen

CEO Yuelei Shen found­ed the com­pa­ny’s Bei­jing head­quar­ters in 2009 af­ter test­ing out the con­cept in Mass­a­chu­setts, where he earned a med­ical de­gree. Since then, he has start­ed a sec­ond lo­ca­tion in Jiang­su and grown the team to 600 staffers, lock­ing in aca­d­e­m­ic and in­dus­try clients like the Uni­ver­si­ty of Ox­ford and J&J.

“In the com­ing five years, glob­al R&D ex­pen­di­ture will con­tin­ue to rise, and the phar­ma CRO in­dus­try will be a di­rect ben­e­fi­cia­ry of that,” said CMB man­ag­ing di­rec­tor Kex­i­ang Zhou in a state­ment. “As part of that glob­al ef­fort, the CRO in­dus­try in Chi­na will keep de­vel­op­ing rapid­ly. The ro­bust de­vel­op­ment of drug R&D in Chi­na will al­so con­tribute to its rise. Bio­cy­to­gen has a sol­id foun­da­tion as an in­te­grat­ed bi­o­log­ics CRO, and we are very hap­py to sup­port their next step.”

As a sup­pli­er of im­mun­od­e­fi­cient and im­mune check­point hu­man­ized mice, Bio­cy­to­gen has ben­e­fit­ed from the tail­wind of im­muno-on­col­o­gy world­wide. Its plat­form is built up­on two sys­tems: one sys­tem de­rived from CRISPR/Cas9 and an­oth­er vec­tor con­struc­tion tech­nol­o­gy fo­cused on em­bry­on­ic stem cells.

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

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.

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.

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.

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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.

Francesco De Rubertis

Medicx­i's David Grainger and Francesco De Ru­ber­tis pump €200M in­to six com­pa­nies and what they say is a first-of-its kind fund

In what they’re billing as a first for biotech, David Grainger, Francesco De Rubertis and their team at Medicxi have put down €200 million to sweep up stakes in six companies from their predecessor VC and pump new money into them.

Medicxi didn’t disclose which companies it was investing in but the portfolio draws from Index Ventures Life VI, one of the last funds the Medicxi team launched while they were still part of the multinational, tech-focused VC firm Index Ventures. That team kept advising Index on their life sciences portfolio even after they spun out to form their own firm in the middle of 2016.

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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.

#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.