Set to be the first pre-rev­enue biotech to list in Hong Kong, As­cle­tis lays out pri­or­i­ties in IPO ap­pli­ca­tion

As­cle­tis is get­ting the ball rolling on the first pre-rev­enue biotech IPO in Hong Kong.

Hangzhou-based As­cle­tis, whose in-house he­pati­tis C drug is on the brink of ap­proval, has ap­plied to list on the stock ex­change of Hong Kong. If it goes through, the bulk of the cash will go to­ward four core prod­ucts, which are in NDA, Phase III, Phase II, and Phase I stages re­spec­tive­ly.

Wu Jinzi

Found­ed by ex-GSK ex­ec Wu Jinzi in 2011, As­cle­tis has a rep­u­ta­tion in Chi­na for be­ing the first do­mes­tic com­pa­ny to de­vel­op a hep C cure. The drug, Gano­vo, is ex­pect­ed to be ap­proved in Q3 of 2018. The team plans to fol­low that up with an­oth­er HCV treat­ment, ravi­dasvir (in-li­censed from Roche), along with HIV drug ASC09, and liv­er can­cer ther­a­py HASC06.

In a heav­i­ly redact­ed ap­pli­ca­tion proof (not to be con­fused with a prospec­tus), the biotech broke down how it plans to use the undis­closed amount of fund­ing:

  • 30% for R&D of core prod­uct pipeline
  • 25% for com­mer­cial­iza­tion of Gano­vo and ravi­dasvir
  • 15% to in-li­cense new drug can­di­dates, to be iden­ti­fied lat­er
  • 10% for R&D of ASC21, an HCV drug from Medi­vir
  • 10% to two in-house ear­ly-stage pro­grams in HBV and NASH
  • 10% for gen­er­al pur­pos­es

Two pre­vi­ous rounds of fi­nanc­ing had brought a col­lec­tive $155 mil­lion in­to As­cle­tis’ ac­counts. Among their back­ers: C-Bridge Cap­i­tal, Qian­Hai Eq­ui­ty In­vest­ment FOF, Gold­man Sachs, and Tasly Phar­ma­ceu­ti­cal. Wu and his wife are the largest share­hold­ers of the com­pa­ny at the mo­ment, own­ing over 60% of the shares.

While the com­pa­ny is still run­ning in the red, it be­gan to ag­gres­sive­ly build up its com­mer­cial­iza­tion team as ear­ly as 2016, which now boasts of 145 mem­bers ready to reach out to hun­dreds of hos­pi­tals once Gano­vo gets the green light. As a whole, As­cle­tis, which start­ed out in 2011 with eight staffers, now has 256 em­ploy­ees.

Now that the ap­pli­ca­tion is in, reg­u­la­tors will be­gin vet­ting the list­ing in a process that could take up to 12 weeks. Just a few days ago, HKEX an­nounced that they will be helped in this process by a pan­el of 13 biotech pro­fes­sion­als, fea­tur­ing names like Zai Lab founder Saman­tha Du and promi­nent VC Jonathan Wang of Or­biMed Asia.

Mor­gan Stan­ley, Gold­man Sachs, and CMS are act­ing as joint spon­sors.

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.

President Donald Trump (via AP Images)

Signs of an 'Oc­to­ber Vac­cine Sur­prise' alarm ca­reer sci­en­tists

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)

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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UP­DAT­ED: Two wild weeks for Grail end in $8B Il­lu­mi­na buy­out

Grail’s whirlwind two weeks have ended in the wealthy arms of its former founder and benefactors.

Illumina has shelled out $8 billion to reacquire the closely-watched liquid biopsy startup they spun out just 5 years ago and sold off much of its shares just 3 years ago. The deal comes nearly two weeks after the well-heeled startup filed for a potentially massive IPO — one that was disrupted just a week later when Bloomberg reported that Illumina was in talks to buy their former spinout for up to $8 billion.

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Roche vaults to the front of the NL­RP3 clin­i­cal race, pay­ing $448M up­front to bag In­fla­zome

Roche is going all in on NLRP3.

The pharma giant is putting down $448 million (€380 million) upfront to snatch Novartis-backed Inflazome, which makes it a clinical player in the space overnight.

Dublin and Cambridge, UK-based Inflazome is the second NLRP3-focused biotech Roche has acquired in less than two years, and although no numbers were disclosed in the Jecure buyout, this is almost certainly a much larger deal.

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Anthony Fauci (AP Images)

A press of­fi­cer at An­tho­ny Fau­ci’s NI­AID was un­masked as a hard-right Covid troll. He just re­tired to­day

William B Crews had been a public affairs specialist at the NIH’s National Institute of Allergy and Infectious Diseases.

That ended today when he informed the agency of his decision to retire, after he was identified as the managing editor at RedState, a prominent Trump loyalist website.

Crews’ RedState duties are performed under the alias streiff. While enjoying the benefits of pseudonymity, he disparaged and worked against NIAID with an incendiary level of rhetoric in the midst of a pandemic.

#ES­MO20: Bris­tol My­ers marks Op­di­vo's sec­ond ad­ju­vant win — eye­ing a stan­dard of care gap

Moving into earlier and earlier treatment lines, Bristol Myers Squibb is reporting that adjuvant treatment with Opdivo has doubled the time that esophageal or gastroesophageal junction cancer patients stay free of disease.

With the CheckMate-577 data at ESMO, CMO Samit Hirawat said, the company believes it can change the treatment paradigm.

While a quarter to 30% of patients typically achieve a complete response following chemoradiation therapy and surgery, the rest do not, said Ronan Kelly of Baylor University Medical Center. The recurrence rate is also high within the first year, Hirawat added.