How about a $477M biotech IPO amid Hong Kong protests? Hen­lius will find out

A third month of protests in Hong Kong is not stop­ping Shang­hai Hen­lius Biotech’s push to get list­ed on its stock ex­change.

The $477 mil­lion IPO bid marks the first big test for HKEX’s nascent biotech cor­ner since the city be­came en­gulfed in po­lit­i­cal tur­moil over a now with­drawn ex­tra­di­tion bill and sub­se­quent po­lice bru­tal­i­ty. Bloomberg has pre­vi­ous­ly re­port­ed that the com­pa­ny was eye­ing as much as $600 mil­lion.

While sev­er­al biotech play­ers — in­clud­ing Al­pham­ab, SinoMab and Tasly Bio­phar­ma — have sent in IPO ap­pli­ca­tions over the sum­mer, the last raise hap­pened in ear­ly June just days be­fore a mil­lion-strong march kicked off the on­go­ing un­rest. Han­soh, a fast-grow­ing phar­ma pow­er­house, har­nessed a $1 bil­lion wind­fall.

Hen­lius could be look­ing at a val­u­a­tion be­tween $3 bil­lion to $3.5 bil­lion, Reuters re­port­ed. Ac­cord­ing to a term sheet re­viewed by the newswire, four cor­ner­stone in­vestors have put down $140 mil­lion, in­clud­ing a $90 mil­lion con­tri­bu­tion from Qatar In­vest­ment Au­thor­i­ty.

Hen­lius is al­so float­ing its pub­lic de­but just as the HKEX made a sur­prise pro­pos­al to merge with the Lon­don Stock Ex­change for £30 bil­lion ($36.6 bil­lion).

“They are clear­ly push­ing to be­come the pre­mier ex­change out­side the US and it is seem­ing more cred­i­ble,” a chief in­vest­ment of­fi­cer with a US as­set man­ag­er told the Fi­nan­cial Times.

When the Hong Kong bourse first opened its doors to pre-rev­enue biotechs last year in an ap­par­ent ef­fort to be­come the Nas­daq for Chi­nese drug de­vel­op­ers, Hen­lius quick­ly sur­faced as an ear­ly be­liev­er that could be in­ter­est­ed in an IPO. Con­ceived as a joint ven­ture of Fo­s­un and Hen­lius to fo­cus ini­tial­ly on biosim­i­lars, the team has se­cured ap­proval to mar­ket a MabThera/Rit­ux­an copy­cat in Chi­na, with knock­offs of Her­ceptin and Hu­mi­ra to fol­low.

Hen­lius first knocked on HKEX doors last De­cem­ber but their fil­ing has since lapsed. They re­filed the IPO in Ju­ly.

Grow­ing ac­cep­tance of ac­cel­er­at­ed path­ways for nov­el treat­ments: but does reg­u­la­to­ry ap­proval lead to com­mer­cial suc­cess?

By Mwango Kashoki, MD, MPH, Vice President-Technical, and Richard Macaulay, Senior Director, of Parexel Regulatory & Access

In recent years, we’ve seen a significant uptake in the use of regulatory options by companies looking to accelerate the journey of life-saving drugs to market. In 2018, 73% of the novel drugs approved by the U.S. Federal Drug Administration (FDA) were designated under one or more expedited development program categories (Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval).ᶦ

Bi­cy­cle Ther­a­peu­tics takes Roche's Genen­tech on an up to $2B im­muno-on­col­o­gy ride

Bicycle Therapeutics — which is developing a new class of chemically synthesized drugs designed to be pharmacologically as active as biologics, yet manufactured as small molecules —  has scored another big partner: Roche’s Genentech.

The transatlantic biotech, which was created in 2009 and made its public debut a decade later, gets $30 million upfront and a meaty $1.7 billion in potential milestone payments in an early discovery immuno-oncology collaboration with Genentech.

When drug val­ue as­sess­ment meets re­al-world ev­i­dence: ICER en­lists Ae­tion in pric­ing eval­u­a­tion

In a union of two of the hottest trends in the US biopharma world, ICER is teaming up with a high-profile company to integrate real-world evidence in their assessment of treatment value.

The drug pricing watchdog — formally the Institute for Clinical and Economic Review — said it will utilize Aetion’s evidence platform in “select upcoming assessments” and their new 24-month re-evaluations of drugs granted accelerated approval by the FDA.

First US Covid-19 tri­als set to get un­der­way in Ne­bras­ka and Wash­ing­ton, backed by NIH

The first US clinical trials on the novel coronavirus are scheduled to get underway next month at the University of Nebraska Medical Center, where American passengers were taken after being evacuated from the Diamond Princess cruise ship, and at the Kaiser Permanente Washington Health Research Institute. Both trials are sponsored by the NIH’s National Institute for Allergy and Infectious Diseases, which has led the US’s medical response to the outbreak.

Anthony Fauci (AP Images)

UP­DAT­ED: NIH-part­nered Mod­er­na ships off its PhI-ready coro­n­avirus vac­cine can­di­date to a sea of un­cer­tain­ty

Off it goes.

Moderna has shipped the first batch of its mRNA vaccine against SARS-CoV-2 from its manufacturing facility in Norwood, Massachusetts, to the National Institute of Allergy and Infectious Diseases in Bethesda, Maryland, for a pioneering Phase I study.

It’s a hectic race against time. In the 42 days since Moderna selected the sequence they would use to develop their vaccine — a record time, no less — the number of confirmed cases around the world has surged astronomically from a few dozen to over 80,000, per WHO and Johns Hopkins estimates.

The candidate that they came up with, mRNA-1273, encodes for a prefusion stabilized form of the spike protein, which gives the virus its crown shape and plays a key role in transmission. The Coalition for Epidemic Preparedness Innovations, the Oslo-based group better known as CEPI, funded the manufacture of this batch.

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Sanofi out­lines big API plans as coro­n­avirus out­break re­port­ed­ly threat­ens short­age of 150 drugs

As the world becomes increasingly dependant on Asia for the ingredients of its medicines, Sanofi sees business to be done in Europe.

The French drugmaker said it’s creating the world’s second largest active pharmaceutical ingredients (API) manufacturer by spinning out its six current sites into a standalone company: Brindisi (Italy), Frankfurt Chemistry (Germany), Haverhill (UK), St Aubin les Elbeuf (France), Újpest (Hungary) and Vertolaye (France). They have mapped out €1 billion in expected sales by 2022 and 3,100 employees for the new operations headquartered in France.

Mallinck­rodt, once the na­tion’s largest oxy­codone pro­duc­er, an­nounces ten­ta­tive $1.6B set­tle­ment

Three years after it first paid out fines for its role in the US opioid abuse epidemic, Mallinckrodt has announced an agreement-in-principle that will see the company pay out $1.6 billion and place its generics unit in bankruptcy.

The tentative deal would settle hundreds of lawsuits from state and local governments over Mallinckrodt’s role in the epidemic, while also helping address the company’s increasingly mountainous debt. Although Purdue Pharma has drawn the bulk of both public and legal acrimony for opioid sales, documents made public earlier this year showed that Mallinckrodt subsidiary SpecGx, along with the generic subsidiaries of Teva and Endo Pharmaceuticals, accounted for the vast majority of the 76 billion opioid pills distributed from 2006 to 2012. Mallinckrodt was at the top of that list.

UP­DAT­ED: NGM Bio takes leap for­ward in crowd­ed NASH field

South San Francisco-based NGM Bio may have underwhelmed with its interim analysis of a key cohort from a mid-stage NASH study last fall — but stellar topline data unveiled on Monday showed the compound induced significant signs of antifibrotic activity, NASH resolution and liver fat reduction, sending the company’s stock soaring.

There are an estimated 50+ companies focused on developing drugs for non-alcoholic steatohepatitis, or NASH, a common liver disease that has long flummoxed researchers. The first wave of NASH drug developers struggled with efficacy as well as safety — and companies big and small have crashed and burned.

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UP­DAT­ED: No­var­tis' plans to wres­tle Eylea mar­ket share take a hit as Beovu is linked to safe­ty con­cerns

While Regeneron’s flagship eye therapy Eylea hurtles towards a patent cliff, the sales of its main rival — Novartis’ Beovu — could be tainted by safety concerns.

On Sunday night, Chicago-based American Society of Retina Specialists (ASRS) issued a note to members about 14 cases of retinal vasculitis (including 11 cases of occlusive retinal vasculitis) — a sight-threatening inflammatory eye condition that involves the retinal vessels — across 46,000 injections administered since Beovu’s launch in November 2019, Wall Street analysts reported.

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