Shang­hai-based Ever­est Med­i­cines CEO has hit the com­pa­ny’s ex­it door.

Ker­ry Blan­chard has re­signed as the CEO and as a mem­ber of the board of di­rec­tors, ef­fec­tive im­me­di­ate­ly, Ever­est an­nounced Fri­day. Af­ter spend­ing near­ly 17 years at Eli Lil­ly where he rose to the rank of VP, Blan­chard spent three years as a top ex­ec­u­tive for oth­er phar­ma com­pa­nies in Chi­na, in­clud­ing a year-long stint at In­novent Bi­o­log­ics.

In 2020, Ever­est brought Blan­chard on as the CEO, and short­ly af­ter he led the com­pa­ny’s IPO, rais­ing HK$3.495 bil­lion ($440 mil­lion) to ad­vance its pipeline of dis­cov­ery drugs in on­col­o­gy, au­toim­mune dis­or­ders, car­dio-re­nal dis­eases and in­fec­tious dis­eases.

While Blan­chard will no longer serve as the CEO, he will re­main as an ad­vi­sor to the com­pa­ny for six months. Mean­while, the com­pa­ny is look­ing for his re­place­ment.

Wei Fu

“Fol­low­ing an ex­ten­sive search in the past few months, we are de­light­ed to have iden­ti­fied a fi­nal­ist among a short list of CEO can­di­dates, with a broad set of ex­per­tise across clin­i­cal de­vel­op­ment, reg­u­la­to­ry af­fairs and com­mer­cial­iza­tion,” said Wei Fu, Ever­est’s chair­man, in a press state­ment.

“We ex­pect to have the new CEO join Ever­est in the com­ing month,” he added.

In June 2022, Ever­est won ap­proval for Trodelvy for adult pa­tients with un­re­sectable lo­cal­ly ad­vanced or metasta­t­ic triple-neg­a­tive breast can­cer. This marked the com­pa­ny’s first ap­proval in its home coun­try.

Ever­est had orig­i­nal­ly ob­tained Trodelvy rights through a 2019 deal with Im­munomedics, which saw the for­mer shell out $65 mil­lion up­front and $60 mil­lion. The deal al­so came with up to $710 mil­lion in mile­stones head­ed Im­munomedics’ way — which was ac­quired by Gilead in late 2020.

How­ev­er, in Au­gust 2022, Ever­est sold Trodelvy’s Chi­na rights back to Gilead for a $280 mil­lion up­front pay­ment with an­oth­er $175 mil­lion in mile­stone pay­ments.

Ac­cord­ing to a fil­ing on the Hong Kong Ex­change, Ever­est said “the broad­er macro­eco­nom­ic and cap­i­tal mar­kets back­drop,” and “the busi­ness prospects, the in­vest­ment nec­es­sary and risks as­so­ci­at­ed with com­mer­cial­iz­ing” as rea­sons for sell­ing Trodelvy rights.

The com­pa­ny said the mon­ey from the deal would be used to lead to a stronger bal­ance sheet. The pro­ceeds would go to­wards build­ing its drug pipeline, strength­en­ing its drug dis­cov­ery ca­pa­bil­i­ties, and fo­cus­ing on the de­vel­op­ment of Ne­fe­con, a kid­ney dis­ease drug.

Mean­while, Gilead will al­so re­gain Trodelvy rights in Macau, Hong Kong, Tai­wan, South Ko­rea, Sin­ga­pore, In­done­sia, the Philip­pines, Viet­nam, Thai­land, Malaysia and Mon­go­lia.

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.

A handful of CDMOs have made changes at the top over the past few weeks, including Genezen and Curia.

That also includes Australian CDMO BioCina, which announced last week that Mark Womack would be taking the helm. Womack previously served as chief business officer at AGC Biologics, CEO of Indian manufacturer Stelis Biopharma and most recently, CEO at CDMO KBI Biopharma and Selexis SA.

BioCina completed the takeover of a Pfizer manufacturing facility in Adelaide in 2021 and is now prepping for wider growth. Endpoints News sat down with Womack to discuss his new role, plans for the future, and how to compete in the wider CDMO market. This interview has been edited for brevity and clarity.