Frank Zhang isn’t go­ing back to Leg­end Biotech any time soon.

Sal­ly Wang

More than a month af­ter the Som­er­set, NJ-based com­pa­ny dis­closed that Zhang was placed un­der house ar­rest in Chi­na for a cus­toms in­ves­ti­ga­tion, it has in­stalled Ying Huang — its CFO and in­ter­im CEO since late Sep­tem­ber — as the per­ma­nent leader, while tap­ping board di­rec­tor Ye (Sal­ly) Wang as the chair­woman.

Zhang used to hold both of those ti­tles. In a state­ment, Leg­end said he re­mains on the board of di­rec­tors and of­fered his sup­port through a writ­ten proxy. There is no up­date on his sta­tus.

The shock­ing turn of events in Sep­tem­ber, Leg­end said, sur­round­ed sus­pect­ed vi­o­la­tions of im­port and ex­port reg­u­la­tions by Gen­Script. While Leg­end had al­ready been spun out from the Hong Kong-list­ed CRO and had its own Nas­daq list­ing by then, it re­mained a sub­sidiary and some of its staffers were for­mer Gen­Script em­ploy­ees. As part of their in­spec­tion of Gen­Script of­fices in Nan­jing and Zhen­jiang, Chi­na’s Cus­toms An­ti-Smug­gling De­part­ment al­so raid­ed Leg­end.

Ying Huang

Hav­ing risen from a vir­tu­al un­known to a star play­er part­nered with J&J — and rid­ing on that to a $424 mil­lion IPO ear­li­er this year — Leg­end’s shares took a beat­ing from the news. The in­ci­dent al­so cast a cloud on the US/Chi­na bio­phar­ma deal­mak­ing land­scape, where trans­paren­cy and clear ex­pec­ta­tions are crit­i­cal.

But Leg­end has vowed to en­sure that its pipeline of cell ther­a­pies will move ahead on time. The on­ly press re­lease it’s is­sued since Zhang was placed un­der house ar­rest fea­tured new da­ta from a piv­otal US study con­duct­ed with J&J, af­firm­ing the ef­fi­ca­cy of its BC­MA CAR-T with a 94% re­sponse rate and 55% com­plete re­sponse rate. (It al­so re­vealed that out of 97 pa­tients in the study, 10 died.)

The new ap­point­ments, in the same way, are all about “en­hanc­ing op­er­a­tional ex­e­cu­tion.”

Wang co-found­ed Gen­Script with Zhang in 2002, serv­ing as the chief op­er­at­ing of­fi­cer, pres­i­dent and board mem­ber at var­i­ous points. Huang, a sea­soned biotech an­a­lyst who came on board in Ju­ly 2019, helped lead Leg­end’s crossover round and IPO.

The duo will be over­see­ing an ex­pand­ed pipeline at Leg­end, which now fea­tures a Phase I al­lo­gene­ic can­di­date tar­get­ing BC­MA.

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.