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.

Op­ti­miz­ing Cell and Gene Ther­a­py De­vel­op­ment and Pro­duc­tion: How Tech­nol­o­gy Providers Like Corn­ing Life Sci­ences are Spurring In­no­va­tion

Remarkable advances in cell and gene therapy over the last decade offer unprecedented therapeutic promise and bring new hope for many patients facing diseases once thought incurable. However, for cell and gene therapies to reach their full potential, researchers, manufacturers, life science companies, and academics will need to work together to solve the significant challenges facing the industry.

Pfiz­er, Sarep­ta and two oth­ers sug­gest Duchenne drug safe­ty is­sues tied to "class ef­fect"

Since the first experimental Duchenne gene therapy programs came about, the space has proven rife with safety issues and patient deaths in clinical trials. Pfizer and three biotechs now think they’ve found a reason why.

The four companies suggested there may be a “class effect” causing the adverse events in Duchenne gene therapies, they wrote in a new study. They specifically highlighted how side effects in five patients across three trials, who all showed muscle weakness with cardiac involvement, were “strikingly similar.”

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Pre­sent­ing a live End­points News event: Man­ag­ing a biotech in tur­bu­lent times

Biotech is one of the smartest, best educated industries on the planet. PhDs abound. We’ve had a long enough track record to see a new generation of savvy, experienced execs coming together to run startups.

And in these times, they are being tested as never before.

Biotech is going through quite a rough patch right now. For 2 years, practically anyone with a decent resume and some half-baked ideas on biotech could start a company and get it funded. The pandemic made it easy in many ways to pull off an IPO, with traditional road shows shut down in exchange for a series of quick Zoom meetings. Generalist investors flocked as the numbers raised soared into the stratosphere.

Martin Shkreli (Dennis Van Tine/MediaPunch/IPX)

In­fa­mous biotech ex­ec Mar­tin Shkre­li gets out of prison, hits the street

Martin Shkreli, the infamous biotech CEO who made headlines for his jeering assault on a legion of critics in and out of Congress, is back on the streets after 4 years inside a federal penitentiary.

Shkreli’s attorney put out a statement Wednesday afternoon saying that the “pharma bro” had been transferred to a halfway house in New York with a few more months to go under federal custody, slated to end September 14. Attorney Benjamin Brafman acknowledged the release and vowed that he and Shkreli are keeping quiet.

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De­spite fed­er­al ef­forts to di­ver­si­fy clin­i­cal tri­als, progress re­mains 'stag­nan­t' — re­port

While calls to diversify clinical trials have grown louder in recent years — gaining support from federal agencies such as the FDA and NIH — progress has largely stalled, according to a new report from the National Academies of Sciences, Engineering and Medicine.

Swaths of patients in racial and ethnic minority groups, as well as LGBTQIA+, pregnant and older adult populations continue to be left out of clinical trials. While some advances have been made in the last 30 years — women now account for roughly half of clinical trial participants — growth in other areas remains stagnant, according to the report, which was mandated by Congress and sponsored by the NIH.

Paul Chaplin, Bavarian Nordic president and CEO

Bavar­i­an Nordic se­cures BAR­DA con­tract for small­pox vac­cine

It seems that smallpox vaccination production is weighing on the mind of the US government. And manufacturer Bavarian Nordic is the latest company to benefit.

Just a few days after Emergent, a company that has made government contracts its lifeblood, acquired the exclusive rights to Tembexa from Chimerix, with a $225 million cash payment and an expected BARDA contract, the agency has offered a contract for smallpox vaccine production.

Frank Pallone (D-NJ), House Energy and Commerce Committee chair (Kevin Dietsch/Pool via AP Images)

House com­mit­tee unan­i­mous­ly ad­vances FDA user fee leg­is­la­tion with ac­cel­er­at­ed ap­proval tweaks

The House Energy and Commerce Committee on Wednesday offered a rare show of bipartisan support for a bill that would provide the FDA with user fees for the next five years.

The committee voted 55-0 to advance the quinquennial user fee bill to the full House floor, which if approved, will allow the FDA to use biopharma funds to hire new reviewers, and hit new marks as outlined in the user fee deals that the FDA and biopharma companies forged over the past several years.

Lina Khan, FTC chair (Saul Loeb/Pool via AP)

New FTC com­mis­sion­er could turn the tide for an in­ves­ti­ga­tion in­to PBMs

The Senate last week voted along party lines, 51-50, with Vice President Kamala Harris casting the tie-breaker, to make President Biden appointee Alvaro Bedoya the deciding vote on a split 2-2 Federal Trade Commission.

The addition of Bedoya to the FTC could not only spell more trouble for biopharma M&A activity, as he may align with his Democrat partners to break the FTC ties, but it may also mean that FTC Chair Lina Khan has what she needs to move forward on a study around the pharma middlemen known as pharmacy benefit managers.

Henrietta Lacks

UP­DAT­ED: Fed­er­al judge weighs mo­tion to dis­miss HeLa law­suit against Ther­mo Fish­er

The story of Henrietta Lacks’ immortal cell line and her family’s fight for justice caught the attention of national media outlets and Hollywood years ago. Now, the case faces an uncertain fate as a Baltimore federal judge considers tossing the case.

After a hearing on Tuesday, Judge Deborah Boardman is weighing Thermo Fisher’s motion to dismiss the claims against it on the grounds that the statute of limitations has passed, and the continuing harm doctrine does not apply. Boardman is grappling with the “extraordinarily unique facts” of the case, according to Maryland Matters, which first reported the news.