Frank Zhang (AP Images)

Leg­end Biotech has a new chair­woman and per­ma­nent CEO. But where is Frank Zhang?

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.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Lat­est on ul­tra-rare dis­ease ap­proval; Pos­i­tive, if mixed, signs for Bio­gen's ALS drug; Clay Sie­gall finds a new job; and more

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Over the last four years, we’ve honored 80 women whose extraordinary accomplishments have changed the game in biopharma R&D. You can now nominate someone to be highlighted in this year’s special report. Details are here.

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FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

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.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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Stuart Peltz, former PTC Therapeutics CEO

Stu­art Peltz re­signs as PTC Ther­a­peu­tics CEO af­ter 25 years

Stuart Peltz, the longtime CEO of PTC Therapeutics who’s led the rare disease drug developer since its founding 25 years ago, is stepping down.

Succeeding him in the top job is Matthew Klein, who joined PTC in 2019 and was promoted to chief operating officer in 2022. In a call with analysts, he said the CEO transition has been planned for “quite some time” — in fact, as part of it, he gave the company’s presentation at the JP Morgan healthcare conference earlier this year.

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Bet­ter Ther­a­peu­tics cuts 35% of staff while await­ing dig­i­tal ther­a­peu­tic 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.

FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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Mark Womack, BioCina CEO

Q&A: BioCi­na’s new CEO Mark Wom­ack on the CD­MO he says is 'worth trav­el­ing over'

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.

No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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