As­cle­tis reaps record $400M from Hong Kong in­vestors in the ex­change's first-ever pre-rev­enue biotech list­ing

The first pre-rev­enue biotech to list on Hong Kong’s stock ex­change has land­ed. And its suc­cess will like­ly spur plen­ty of more such of­fer­ings in search of a big pay­off.

As­cle­tis has raised $400 mil­lion by sell­ing 224 mil­lion new shares at around $1.78 (HK$14) — right in the mid­dle of its an­tic­i­pat­ed HK$12 to HK$16 range, Reuters re­port­ed. It’s sched­uled to be­gin trad­ing on Au­gust 1, less than three months af­ter it first filed for the IPO.

GIC, Sin­ga­pore’s sov­er­eign wealth fund, signed on to be the cor­ner­stone in­vestor and com­mit­ted $75 mil­lion for around 19% of the IPO shares. The rest — which in turn ac­counts for about 20% of As­cle­tis’ en­larged share cap­i­tal — was all snapped up in an over­sub­scribed fren­zy.

Jinzi Wu

Found­ed by ex-GSK ex­ec Jinzi Wu 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.

Be­ing the first biotech to test the new list­ing rules wasn’t easy. Wu pre­vi­ous­ly said that As­cle­tis faced “some chal­lenges” in nail­ing down the com­pa­ny’s val­u­a­tion.

The smooth tra­jec­to­ry of As­cle­tis’ IPO like­ly paves the way for the six oth­er biotechs and one CRO — from Hua Med­i­cine to Stealth Bio­Ther­a­peu­tics — that’s of­fered their own IPO pitch.

It’s al­so a mile­stone for HKEX, which has been an­gling to be­come an IPO des­ti­na­tion for biotech up­starts, es­pe­cial­ly the kind that’s been pop­ping up in main­land Chi­na the past decade.

Just a few days ago, word came out that the list­ing com­mit­tee is dis­cussing a sec­ondary list­ing with BeiGene $BGNE — the Bei­jing-based, Cel­gene-part­nered biotech whose Nas­daq list­ing (and im­mense suc­cess) had been seen as an im­pe­tus for Hong Kong to change its rules.

In its fil­ing, BeiGene wrote that it be­lieves it’s “well po­si­tioned to cap­ture the sig­nif­i­cant mar­ket op­por­tu­ni­ties in Chi­na” with its core as­sets zanubru­ti­nib, tislelizum­ab and pami­parib, all of which would ben­e­fit from the raise, from clin­i­cal tri­als to reg­is­tra­tion and com­mer­cial­iza­tion in both Chi­na and the US.

But the star to­day is As­cle­tis. The past year has brought a rush of biotech de­buts in the US, with Ru­bius claim­ing the largest biotech IPO so far on Nas­daq — rais­ing $241 mil­lion — while De­nali scored $250 mil­lion in late 2017. Now As­cle­tis, a com­pa­ny not well known out­side of Chi­na, has left those top per­form­ers in the dust, in­clud­ing Ax­o­vant, which held the record for the biggest biotech IPO.

With the fresh in­fu­sion of cash, Wu and his team can now car­ry on with the planned R&D and com­mer­cial­iza­tion of core prod­ucts, as well as in-li­cens­ing more drugs.

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 Ju­ly He are still the largest share­hold­ers of the com­pa­ny at the mo­ment, own­ing over 60% of the shares.

Com­mu­ni­cat­ing the val­ue of pre­ci­sion med­i­cine

By Natasha Cowan, Content Marketing Manager at Blue Latitude Health.
Many stakeholders are confused by novel precision medicines, including patients and healthcare professionals. So, how can industry help them to navigate this complexity?

Precision medicine represents a new paradigm in healthcare. It embodies the shift from treating many patients with the same therapy, to having the tools to identify the best treatment for every patient.

(Image: Associated Press)

Amarin emerges from an ex­pert pan­el re­view with a clear en­dorse­ment for Vas­cepa and high odds of suc­cess when the FDA weighs in for­mal­ly

Several FDA experts who gathered Thursday to consider the landmark approval of Vascepa to reduce cardio events in an at-risk population voiced their unease about various aspects of the efficacy and safety data, or ultimately the population it should be used to treat. But the overwhelming belief that the data pointed to the drug’s benefit and clearly outweighed risks carried the day for Amarin.

The panel voted unanimously (16 to 0) to support the company’s positive data presentation — backing an OK for expanding the label to include reducing cardio risk. The vote points Amarin $AMRN down a short path to a formal decision by the FDA, with the odds heavily in its favor. Chances are the rest of the questions about the future of this drug will be hashed out in the label’s small print.

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What does $62B buy you these days? A lot, says Take­da ex­ecs as the phar­ma play­er promis­es a block­buster R&D fu­ture

First comes the $62 billion buyout. Then comes the asset auction and reorganization to pay down debt. Now comes the detailed pledge of a bigger, brighter future in drug development.

That’s where Takeda finds itself on R&D day today, about 11 months after closing on their Shire acquisition. R&D chief Andy Plump is joining CEO Christophe Weber and other top members of the team to outline a new set of priorities in the greatly expanded pipeline at Takeda, which has jumped into the top ranks of the world’s pharma giants in the wake of the Shire deal.

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BeiGene CEO John Oyler at an Endpoints event in Shanghai, October 2018 (Credit: Endpoints News/PharmCube)

UP­DAT­ED: Chi­na's BeiGene scores first-ever FDA ap­proval — but can they carve up J&J's block­buster fran­chise?

Weeks after Amgen took a $2.7 billion stake in BeiGene, the Beijing-based biotech has secured its first-ever FDA approval for zanubrutinib, a BTK inhibitor, months ahead of schedule.

BeiGene’s drug, branded as Brukinsa, has secured accelerated approval for adult patients with mantle cell lymphoma (MCL) — a typically aggressive, rare, form of blood cancer — who have received at least one prior therapy.

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Spe­cial re­port: Twen­ty ex­tra­or­di­nary women in bio­phar­ma R&D who worked their way to the top

What differentiates a woman leader in biopharma R&D from a man?

Not much, except there are fewer of them in senior posts. Data suggest women are not more risk-averse, family-oriented or less confident than their male counterparts — indeed the differences between the two sexes are negligible. But a glance at the top R&D positions in Big Pharma leaves little doubt that upward migration in the executive ranks of biopharma R&D is tough.

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GSK's asth­ma bi­o­log­ic Nu­cala scores in rare blood dis­or­der study

GlaxoSmithKline’s asthma drug Nucala, which received a resounding FDA rejection for use in chronic obstructive pulmonary disease (COPD) last year, has shown promise in a rare blood disorder.

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Mer­ck buys a fledg­ling neu­rode­gen­er­a­tive biotech spawned by an old GSK dis­cov­ery al­liance. What’s up with that?

Avalon Ventures chief Jay Lichter has a well-known yen for drug development programs picked up in academia. And what he found in Haoxing Xu’s lab at the University of Michigan pricked his interest enough to launch one of his umbrella biotechs in San Diego.

Xu’s work laid the foundation for Avalon to launch Calporta, which has been working on finding small molecule agonists of TRPML1 (transient receptor potential cation channel, mucolipin subfamily, member 1) for lysosomal storage disorders. And that pathway, they believe, points to new approaches on major market neurodegenerative diseases like Parkinson’s, ALS and Alzheimer’s.

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Carson Block. Muddy Waters via YouTube

Shorts ga­lore: Mud­dy Wa­ters sees slide for Pep­tiDream, tweets con­cerns about Fi­bro­Gen's new da­ta

The short seller Muddy Waters is taking aim at Japan’s most profitable biotech, projecting a slide for a company that has skyrocketed over the last four years. Meanwhile, the firm tweeted out an analysis accusing FibroGen of manipulating data to obscure safety concerns in their latest reveal, although some investors seem satisfied by the biotech’s explanation.

Muddy Waters shorted PeptiDream, a Japanese biotech-for-hire that leveraged its peptide library into partnerships with some of the world’s largest pharmaceutical companies, a 50% profit margin and $6 billion valuation. The firm noted that despite its esteem, PeptiDream has failed to bring a drug to market 13 years after its 2006 launch (although this is not especially rare for biotech).

Pin­cer move­ment: Cal­i­for­nia biotech gets $35M to suf­fo­cate can­cer in co­or­di­nat­ed at­tack

Having served in Afghanistan, the navy veteran leading California-based EpicentRx wants to leave no patient behind with his arsenal of anti-cancer drugs. On Thursday, the company was given a $35 million boost to further its mission.

The injection of funds will be used to shepherd its late-stage CD47 drug, RRx-001, to the FDA for marketing, and its oncolytic virus program into the clinic.

RRx-001, engineered as an agent that makes tumor cells more sensitive to therapy, is in a Phase III trial in combination with chemotherapy for use in third-line and beyond small cell lung cancer (SCLC). The drug has been granted orphan drug designation from FDA for SCLC, neuroendocrine cancer and glioblastoma.