A hefty phar­ma IPO is com­ing to Hong Kong.

Sim­cere isn’t one of the group of pre-rev­enue biotechs tak­ing ad­van­tage of Hong Kong’s 2-year-old new rules that opened up the stock ex­change. A clos­er coun­ter­part would be Han­soh, which reaped a $1 bil­lion wind­fall from its HKEX de­but a year ago: a sto­ried pow­er­house com­pa­ny that bags siz­able rev­enue from a slate of old­er gener­ic drugs. (Co­in­ci­den­tal­ly, both com­pa­nies have head­quar­ters in the province of Jiang­su.)

Jin­sheng Ren

Even those who are not fa­mil­iar with the com­pa­ny would in­stant­ly rec­og­nize its part­ners: Over the years, Sim­cere has inked col­lab­o­ra­tions with Bris­tol My­ers Squibb and Am­gen, where it would de­vel­op and pro­mote their drugs in Chi­na.

But it’s 2020 and old­er or me-too drugs — even when cou­pled with a for­mi­da­ble sales force — aren’t go­ing to cut it.

Jin­sheng Ren, the com­pa­ny’s founder, chair­man and CEO, saw the tide turn­ing by 2013. That year, he led a con­sor­tium to take Sim­cere pri­vate af­ter six years list­ed on the NYSE. At the same time, he made “in­no­va­tion” a key theme, in­cu­bat­ing new do­mes­tic star­tups while buy­ing in­to glob­al ven­ture funds such as MPM Cap­i­tal and Al­ly Bridge Group.

With a Hong Kong sub­sidiary set up in 2015, Sim­cere was ru­mored to be seek­ing a $1 bil­lion raise as ear­ly as 2016, al­though it nev­er did ma­te­ri­al­ize.

More re­cent­ly, it di­rect­ly ac­quired mi­nor­i­ty in­ter­ests in cell ther­a­py biotech TCR­Cure and di­ag­nos­tics play­er 3D Med­i­cines, as well as clinch­ing a pro­mo­tion deal for Al­pham­ab’s sub­cu­ta­neous PD-L1 in­hibitor.

With a new man­u­fac­tur­ing plant — its fifth — for mon­o­clon­al an­ti­bod­ies and oth­er bi­o­log­ics slat­ed to come on­line in June, Sim­cere sees CAR-T and oth­er cell ther­a­pies as its new fron­tier. The R&D cen­ter in Boston, es­tab­lished in late 2019, will take the lead on these ad­vanced tech­nolo­gies.

Look for more deals, too, ex­ecs wrote in the S-1:

In par­tic­u­lar, we plan to fo­cus on procur­ing drug can­di­dates that have ini­ti­at­ed Phase II/III clin­i­cal tri­als or rev­o­lu­tion­ary tech­nolo­gies and drug can­di­dates that are still in ear­ly stage for com­mer­cial­iza­tion in Chi­na.

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.

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.