Bil­lion-dol­lar biosim mak­er mulls $500M Hong Kong IPO

A Chi­nese biosim­i­lar mak­er val­ued at $1.5 bil­lion might be the first to list its stock on Hong Kong’s ex­change un­der new rules al­low­ing star­tups and biotechs to go pub­lic.

The com­pa­ny, called Shang­hai Hen­lius Biotech, could do an IPO rais­ing $500 mil­lion as ear­ly as the sec­ond half of this year, ac­cord­ing to un­named sources in­ter­viewed by Bloomberg.

A list­ing like this could be a first for Hong Kong’s stock ex­change. Un­til re­cent­ly, Hong Kong did not al­low pre-rev­enue and pre-prof­it com­pa­nies to list, as they were a per­ceived risk to in­vestors. But this cut out the bulk of biotechs op­er­at­ing in the red while de­vel­op­ing drugs. The strict rules led Chi­nese biotech com­pa­nies like BeiGene to raise cap­i­tal in the US. On the Nas­daq, BeiGene’s stock has grown near­ly 310% over the past two years, bring­ing its mar­ket cap up to $6.3 bil­lion. Not bad for a com­pa­ny with bare­ly any rev­enue, and none from prod­uct sales as of their lat­est 10-K.

New rules an­nounced in De­cem­ber (and tak­ing ef­fect this year), how­ev­er, al­low com­pa­nies that haven’t earned rev­enue or prof­it to ap­ply for IPOs in Hong Kong — as long as they’re val­ued at HK$1.5 bil­lion (US$192 mil­lion). The com­pa­nies must meet some cri­te­ria first, like be­ing at least two-years old and hav­ing some patents.

“Biotech was cho­sen as the ini­tial fo­cus in widen­ing mar­ket ac­cess for ear­ly stage com­pa­nies as the sec­tor tends to be strict­ly reg­u­lat­ed un­der a regime that sets ex­ter­nal mile­stones on de­vel­op­ment progress,” the Hong Kong stock ex­change wrote in a state­ment to the South Chi­na Morn­ing Post.

Since the new rules were an­nounced, about two dozen tech star­tups and biotech com­pa­nies have made in­quiries di­rect­ly through the ex­change or have en­gaged in­vest­ment banks and pro­fes­sion­al con­sul­tants to ask about rais­ing cap­i­tal in Hong Kong, SCMP re­ports.

Shang­hai Hen­lius makes mon­o­clon­al an­ti­body biosim­i­lar drugs, in­clud­ing a copy­cat of Roche’s can­cer ther­a­py Rit­ux­an that got pri­or­i­ty re­view last month. The com­pa­ny is a joint ven­ture launched by Shang­hai Fo­s­un Phar­ma­ceu­ti­cal and Hen­lius Bio­phar­ma­ceu­ti­cals in 2009. It raised $140 mil­lion last month from in­vestors in­clud­ing Ja­cob­son Phar­ma Corp. in a deal valu­ing the com­pa­ny at more than $1.5 bil­lion.

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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

Take­da swoops in to buy lit­tle biotech part­ner and its celi­ac drug poised to 'change stan­dard of care'

Having spent three years carefully grooming PvP Biologics and its drug for celiac disease, Takeda is happy enough with the proof-of-concept data to buy it all.

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Will a 'risk-of­f' mind­set has­ten cell ther­a­py M&A? Io­vance surges on buy­out chat­ter

Is it time for some cell therapy M&A?

Investors of Iovance Biotherapeutics certainly thought so, sending its stock $IOVA up as much as 40% after Bloomberg reported that the cancer-focused biotech is talking to potential buyers.

While 2019 saw a number of high-profile gene therapy company takeovers — led by Roche’s $4.3 billion bid of Spark as Astellas went for Audentes, Biogen snapped up Nightstar and Vertex absorbed Exonics — large players appeared to prefer partnering on the cell therapy front, particularly when it comes to cancer. Hal Barron put his weight behind Rick Klausner’s startup as he rebuilt GlaxoSmithKline’s cancer pipeline. Takeda turned to MD Anderson to license their natural killer cell therapy.

Bio­gen touts new ev­i­dence from the gene ther­a­py com­pa­ny it wa­gered $800M on

A year ago, Biogen made a big bet on a small gene therapy company. Now they have new evidence one of their therapies could work.

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One less ri­val for Im­muno­vant, as Alex­ion aban­dons FcRn in­hibitor

Less than one year after Alexion parted with $25 million upfront to secure access to a second anti-FcRn asset, it is abandoning the experimental drug. The discontinuation, disclosed at the SVB Leerink Global Healthcare Conference in New York during a fireside chat, bodes well for rival Immunovant.

The drug (ABY-039), partnered for development with Sweden’s Affibody, was forsaken on the basis of early-stage data that was not viewed favorably, Baird and SVB Leerink analysts noted.

Mi­cro­bio­me Q&A: New study maps the vagi­na's 'op­ti­mal mi­cro­bio­ta' — and its im­pli­ca­tions for bio­phar­ma

The widely-held notion that the “optimal” vaginal microbiota is dominated by one strain of lactic-acid producing bacteria has now been challenged in a new paper, published in Nature Communications on Wednesday, which used advanced gene sequencing methods to map out the most comprehensive gene catalog of the human vaginal microbiome.

Things have changed in the more than 50 years since the concept of vaginal microbiota transplants was proposed and subsequently tainted by a Texas-based gynecologist who transplanted the vaginal fluid of women who had bacterial vaginosis into healthy females, suspecting he had isolated the bacteria responsible for the condition.

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Clin­i­cal tri­al spon­sors have to dis­close decade’s worth of un­re­leased da­ta, fed­er­al judge rules

A decade’s worth of unreleased trial data may soon see the light of day.

A New York federal judge ruled this week that the FDA and the NIH have for years misinterpreted a law that would require companies, universities and other clinical trial sponsors to release trial data from studies completed between 2007 and 2017. The ruling covers drugs and medical devices that were experimental when the study was completed but have since been approved, potentially putting hundreds of sponsors out of compliance if they don’t put their results on

Laurie Glimcher and Ansbert Gadicke (Justin Knight, Dana-Farber Cancer Institute)

Ty­ing ba­sic sci­ence to spin­outs, Dana-Far­ber de­buts sis­ter funds to­tal­ing $126M with MPM Cap­i­tal

As one of the most prestigious cancer institutes in the US, Dana-Farber has enjoyed considerable support for its entrepreneurial pursuits, spinning out about 30 companies in the past 12 years.

“Now where we’ve always struggled — where every cancer center struggled — is support of basic science,” Barrett Rollins, chief scientific officer emeritus, told Endpoints News.

And then two of its trustees had an idea. What if they tied philanthropy to investment in Dana-Farber startups, requiring a donation to basic science as a condition for accessing its brightest biotech venture ideas?

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Theft vic­tim or da­ta bul­ly? IQVIA ex­changes blows with small ri­val it says de­stroyed ev­i­dence in le­gal fight

Three years into their legal battle, the plot around health information giant IQVIA and Veeva’s dispute over reference data and software managing those data continues to thicken.

Just a week after IQVIA filed a motion for default judgment in their trade theft suit with salacious allegations that Veeva intentionally deleted evidence that would prove they stole information from the data giant, Veeva said it’s expanding its antitrust counterclaims to put an end to IQVIA’s “long history of abusing its monopoly position.”

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