Photo: Amber Tong, Endpoints News

In a bid to get to Chi­nese pa­tients faster, Shang­hai's I-Mab plans $100M Nas­daq IPO

Aim­ing to be the next Chi­nese com­pa­ny to list on Nas­daq af­ter Zai Lab’s de­but two years ago, the Shang­hai drug de­vel­op­er I-Mab is gun­ning for a $100 mil­lion IPO.

The com­pa­ny — which has raised more than $400 mil­lion in the last three years — has a shrewd strat­e­gy for bi­o­log­ic de­vel­op­ment: it first con­ducts its proof-of-con­cept tri­als in the Unit­ed States and works to­wards get­ting FDA clear­ance for in-hu­man stud­ies.  The da­ta gen­er­at­ed are then used to ad­vance clin­i­cal de­vel­op­ment in Chi­na. Even­tu­al­ly, af­ter the ex­per­i­men­tal drug has been clin­i­cal­ly val­i­dat­ed in the Unit­ed States, the com­pa­ny re­tains Chi­nese rights for fur­ther de­vel­op­ment and com­mer­cial­iza­tion — while re­tain­ing the op­tion to out-li­cense glob­al­ly.

I-Mab’s ap­proach could al­low Chi­nese pa­tients to ac­cess treat­ments con­cur­rent­ly or soon af­ter their mar­ket ap­provals else­where, par­tic­u­lar­ly since Chi­nese of­fi­cials have carved out a path­way for the fast-track ap­proval of drugs sup­port­ed by sol­id over­seas clin­i­cal da­ta and grant­ed pri­or­i­ty re­views. Zai Lab, which has ac­quired a slate of late-stage and com­mer­cial prod­ucts to quick­ly build its port­fo­lio, has ben­e­fit­ed from these Chi­nese re­forms.

I-Mab, mean­while, has a slate of ten clin­i­cal and pre­clin­i­cal bi­o­log­ics for au­toim­mune dis­ease and can­cer, which is on the rise in Chi­na due to pol­lu­tion and lofty rates of smok­ing. Growth in Chi­na’s bi­o­log­ics mar­ket has sur­passed the glob­al bi­o­log­ics mar­ket and is ex­pect­ed to reach $189.4 bil­lion in sales by 2030, I-Mab said, cit­ing a Frost & Sul­li­van re­port.

The com­pa­ny’s glob­al port­fo­lio hous­es mon­o­clon­al an­ti­bod­ies and bi-spe­cif­ic an­ti­bod­ies. Three drugs: TJM2, TJC4 and TJD5 are in phase 1 tri­als in the Unit­ed States — and ap­pli­ca­tions to test TJC4 and TJD5 in hu­mans was grant­ed by Chi­na’s Na­tion­al Med­ical Prod­ucts Ad­min­is­tra­tion (NM­PA) ear­li­er this year.

In its Chi­na port­fo­lio, the com­pa­ny has five home-grown in­ves­ti­ga­tion­al drugs that are in or ready for phase II or phase III tri­als in Chi­na, hav­ing met the re­lat­ed pre-set safe­ty and pre­lim­i­nary ef­fi­ca­cy end­points in ear­ly or mid-stage stud­ies in Eu­rope or the Unit­ed States. TJ202 is in two piv­otal tri­als test­ing its use in mul­ti­ple myelo­ma in Tai­wan, while the NM­PA has en­dorsed test­ing the drug for the same in­di­ca­tions in hu­mans in Chi­na. Da­ta on TJ101 is be­ing com­piled for an ap­pli­ca­tion to test in a reg­is­tra­tional tri­al in Chi­na. For enobli­tuzum­ab, an IND is be­ing prepped for 2020 for a mid-stage tri­al or a piv­otal tri­al. Al­to­geth­er, the com­pa­ny is vy­ing to sub­mit a slate of mar­ket­ing ap­pli­ca­tions come 2021.

The com­pa­ny was es­tab­lished in June 2016 and has inked a num­ber of col­lab­o­ra­tions, in­clud­ing Mor­phoSys, Genex­ine, Macro­Gen­ics, and Fer­ring. It in­tends to list on the Nas­daq with the sym­bol $IMAB.

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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