In­novent to seek $400M-plus on Hong Kong IPO, re­ports say; will it re­vive biotech's for­tunes on HKEX?

With a clear goal to lead the first biosim­i­lar wave in Chi­na while giv­ing a go at new drug in­no­va­tion, In­novent Bi­o­log­ics has been rais­ing im­pres­sive sums of cash in the past cou­ple of years, set­ting some do­mes­tic records along the way. And now, it’s look­ing poised to ride that mo­men­tum all the way to the top of Hong Kong’s stock ex­change.

Michael Yu

Re­ports are emerg­ing that the Shang­hai-based drug­mak­er, which is sched­uled to price its IPO on Oc­to­ber 23, aims to raise be­tween $400 mil­lion to $500 mil­lion. Reuters’ sources put the fig­ure at $422 mil­lion — pos­si­bly mak­ing it the biggest pub­lic de­but of any biotech since they have been al­lowed on­to Hong Kong’s mar­ket this April.

As­cle­tis pre­vi­ous­ly stood on top of that list — al­beit still a short one — at $400 mil­lion, and Hua Med­i­cine fol­lowed up with a $110.5 mil­lion raise. No­tably, Nas­daq-list­ed BeiGene bagged $903 mil­lion but it was through a sec­ondary list­ing.

Strong sup­port from cor­ner­stone in­vestors has boost­ed In­novent’s val­u­a­tion to around $2 bil­lion.

The group, com­pris­ing Sin­ga­pore sov­er­eign wealth fund Temasek, Se­quoia Cap­i­tal Chi­na, Shang­hai-based Green­woods In­vest­ment, Hong Kong-based as­set man­age­ment com­pa­ny Val­ue Part­ners and Amer­i­can fi­nan­cial ser­vices com­pa­ny Cap­i­tal Group, are ac­count­ing for 50% to 60% of the IPO, ac­cord­ing to Chi­nese source Xue­qiu Fi­nance.

Reuters added that In­novent has set a price range of $1.59 to $1.79 (HK$12.5-HK$14).

In its fil­ings, In­novent high­light­ed sin­til­imab — an Eli-Lil­ly part­nered PD-1 in­hibitor cur­rent­ly un­der pri­or­i­ty re­view in Chi­na — as the star of the pipeline. The new in­fu­sion of cash will con­tin­ue to fund the tri­als, reg­is­tra­tion and com­mer­cial­iza­tion leg­work for that and oth­er as­sets in the pipeline, in­clud­ing three block­buster copy­cats — biosim­i­lars of Avastin, Rit­ux­an and Hu­mi­ra.

As one of the ear­li­er biotech uni­corns in Chi­na, found­ed and helmed by Michael Yu, In­novent and its IPO plans have been fol­lowed close­ly. Giv­en the rocky ter­rain its pre­de­ces­sors have found them­selves in — As­cle­tis is now trad­ing at 43% of its de­but price — In­novent’s stock will sure­ly come un­der the spot­light once it goes live at the end of this month.

FDA commissioner Stephen Hahn at the White House (AP Images)

Un­der fire, FDA to is­sue stricter guid­ance for Covid-19 vac­cine EUA this week — re­port

The FDA has been insisting for months that a Covid-19 vaccine had to be at least 50% effective – a measure of transparency meant to shore public trust in the agency and in a vaccine that had been brought forward at record speed and record political pressure. But now, with concerns of a Trump-driven authorization arriving before the election, the agency may be raising the bar.

The FDA is set to release new guidance that would raise safety and efficacy requirements for a vaccine EUA above earlier guidance and above the criteria used for convalescent plasma or hydroxychloroquine, The Washington Post reported. Experts say this significantly lowers the odds of an approval before the election on November 3, which Trump has promised despite vocal concerns from public health officials.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Zai Lab hauls in $761M from Hong Kong IPO to push Ze­ju­la, more bud­ding can­di­dates in Chi­na — re­port

Zai Lab is set to net more than $761 million from its secondary listing in Hong Kong after pricing the IPO at $72.51 (HKD$562) — just a hair below its Nasdaq closing price on Monday, Bloomberg and Nikkei Asian Review reported.

A pioneer in bringing Western drugs to China, co-founder and CEO Samantha Du has more than tripled Zai Lab’s market cap in the three years it’s been public in the US. The HKEX listing is designed to fund R&D and commercialization for the current portfolio while fueling new in-licensing pacts, the biotech wrote in a filing.

Samit Hirawat (Bristol Myers Squibb)

Af­ter bruis­ing re­jec­tion, blue­bird and Bris­tol My­ers Squibb land ide-cel pri­or­i­ty re­view. But will it mat­ter for the CVR?

With the clock all but up, the FDA accepted and handed priority review to Bristol Myers Squibb and bluebird bio’s BCMA CAR-T, keeping a narrow window open for Celgene investors to still cash in on the $9 CVR from the $63 billion Celgene merger.

The acceptance comes five months after the two companies weres slammed with a surprise refuse-to-file that threatened to foreclose the CVR entirely. Today’s acceptance sets the FDA decision date for March 27, 2021 – or precisely 4 days before the CVR deadline of March 31. Given the breakthrough designation and strong pivotal data — 81.5% response rate, 35.2% complete response rate — priority review was largely expected.

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Blueprint CEO Jeff Albers (file photo)

Blue­print plots re­turn to FDA with new Ay­vak­it da­ta in rare con­di­tion — and the an­a­lysts cheer

Over a decade after launch, Blueprint Medicines nabbed the first approval for their first drug earlier this year. Now, as they move forward with a Roche-partnered global launch, they’re touting data that could push them into more patients.

The Jeff Albers-led Cambridge biotech released their full pivotal data for Ayvakit in patients with advanced systemic mastocytosis. In one 53-person study, they showed that 76% of patients responded to the drug, 36% had complete responses and that on average their responses lasted for just over 3 years. A smaller, 32-patient study had a 75% response rate and most were still responding after 10.4 months, the last follow-up.

President Donald Trump (via AP Images)

Signs of an 'Oc­to­ber Vac­cine Sur­prise' alarm ca­reer sci­en­tists. HHS con­tin­ues to claim Azar “will de­fer com­plete­ly to the FDA"

President Donald Trump, who seems intent on announcing a Covid-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the FDA and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Trump — who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA — will take matters into his own hands, running roughshod over the usual regulatory process.

#ES­MO20: Push­ing in­to front­line, Mer­ck and Bris­tol My­ers duke it out with new slate of GI can­cer da­ta

Having worked in parallel for years to move their respective PD-1 inhibitors up to the first-line treatment of gastrointestinal cancers, Merck and Bristol Myers Squibb finally have the data at ESMO for a showdown.

Comparing KEYNOTE-590 and CheckMate-649, of course, comes with the usual caveats. But a side-by-side look at the overall survival numbers also offer some perspective on a new frontier for the reigning checkpoint rivals, both of whom are claiming to have achieved a first.

Norbert Bischofberger, Kronos CEO

Three more biotechs look to jump on­to Nas­daq amid IPO boom, in­clud­ing Nor­bert Bischof­berg­er's Kro­nos

Three drug developers announced plans to go public on Friday, a sign that the IPO window for biopharma is wide open.

First up is Daly City, CA-based Spruce Biosciences. They filed for an $86 million IPO to develop their pipeline for classic congenital adrenal hyperplasia (CAH). Currently, only steroids are available to treat the condition, which affects the adrenal glands above the kidneys. Spruce’s tildacerfont, a non-steroidal option, is in a Phase IIb trial in adults with classic CAH and poor disease control. The company expects a topline readout here in the next 12 to 15 months. The small molecule is also in a Phase IIb study in adults with classic CAH and good disease control. Spruce expects topline data here in the first half of 2022.

Frank Zhang (AP Images)

UP­DAT­ED: Rocked by cus­toms in­ves­ti­ga­tion, Leg­end's CFO takes over as CEO Frank Zhang placed un­der house ar­rest

When Frank Zhang stepped down from GenScript — the contract research group he’s run for 18 years — to take up the CEO post at its CAR-T focused spinout Legend Biotech, he assured analysts that he was in for the long haul.

Just 49 days later, though, he’s been forced to hand back the title.

In a dramatic turn of events, Legend disclosed that Zhang is under house arrest in China as part of a customs investigation involving GenScript. While he remains the chairman, CFO Ying Huang has been tapped to double as interim CEO.

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