A sto­ried Chi­nese phar­ma part­ner of Bris­tol My­ers, Am­gen — and avid biotech sup­port­er — plots HK IPO

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.

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.

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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Zhi Hong, Brii Biosciences CEO

Brii Bio­sciences stops man­u­fac­tur­ing Covid-19 an­ti­body com­bo, plans to with­draw EUA re­quest

Brii Biosciences said it will stop manufacturing its Covid-19 antibody combination, sold in China, and is working to withdraw its emergency use authorization request in the US, which it started in October 2021.

The Beijing and North Carolina biotech commercially launched the treatment in China last July but is now axing the work and reverting resources to other “high-priority programs,” per a Friday update. The focus now is namely hepatitis B viral infection, postpartum depression and major depressive disorders.

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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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Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to clinicaltrials.gov, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

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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 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.

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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