Nine list­ings and $3.8B lat­er, HKEX cel­e­brates one-year biotech an­niver­sary with $194M CRO IPO

So how is Hong Kong stock ex­change’s biotech board do­ing one year af­ter reg­u­la­tors opened up the list­ing regime to pre-rev­enue com­pa­nies in the field?

De­pends on how you look at it.

Charles Li

While on­ly nine biotech com­pa­nies — in­clud­ing one CRO gi­ant — have joined the HKEX this way in the past year, col­lec­tive­ly they have raised $3.8 bil­lion. By IPO pro­ceeds, that makes Hong Kong the sec­ond largest pub­lic biotech hub world­wide af­ter the leader Nas­daq, ac­cord­ing to Re­fini­tiv da­ta cit­ed by the lo­cal South Chi­na Morn­ing Post.

In a sign of the buoy­ant times, the drug dis­cov­ery spe­cial­ists at Vi­va Biotech are re­port­ed­ly eye­ing $150 mil­lion to $194 mil­lion (be­tween HK$1.18 bil­lion and HK$1.52 bil­lion) in their pub­lic de­but. The com­pa­ny first filed last Ju­ly.

Like fel­low CRO WuXi AppTec, Vi­va is mak­ing its pitch to in­vestors with rev­enue on its hands. The Shang­hai-based com­pa­ny is half-in­cu­ba­tor and half-con­tract busi­ness, of­fer­ing both “eq­ui­ty for ser­vice” and “cash for ser­vice” mod­els to US and Chi­nese bio­phar­mas look­ing for out­sourc­ing part­ners. The list­ing is ex­pect­ed to both ex­pand their port­fo­lio — 21 star­tups at last count — and boost their man­u­fac­tur­ing ca­pa­bil­i­ties.

“In gen­er­al, for each of our in­cu­ba­tion projects un­der the EFS mod­el, we plan to con­tribute an av­er­age of US$1.5 mil­lion in cash or via drug dis­cov­ery ser­vices we pro­vide, with an aim to ex­it 50% of our eq­ui­ty/eco­nom­ic in­ter­est in 2.5 years af­ter in­vest­ment and the re­main­ing in­ter­est in 5.5 years af­ter in­vest­ment,” the com­pa­ny wrote in a fil­ing.

Sinopharm Cap­i­tal and two funds con­trolled by Shen­zhen GT­JA In­vest­ment Group came in as the cor­ner­stone in­vestors for the IPO, sub­scrib­ing for a com­bined 26% of the whole of­fer­ing, Caix­in re­port­ed.

The stock is sched­uled to de­but on May 9. Un­til then, the key ques­tion re­mains: Will it per­form more like the ear­ly pur­vey­ors like As­cle­tis, Hua Med­i­cine and BeiGene — all yet to re­cov­er from tur­bu­lence — or rel­a­tive new­com­ers like In­novent, CStone or even CanSi­no (now up more than 70% from IPO price)?

Over­all, though, HKEX chief Charles (Xi­ao­jia) Li would ar­gue they are mak­ing good progress.

“Far from be­ing dis­ap­point­ing, we are very pleased with the ear­ly de­vel­op­ment of our biotech and weight­ed vot­ing rights chap­ters in Hong Kong,” he wrote to the SCMP.

A New Fron­tier: The In­ner Ear

What happens when a successful biotech venture capitalist is unexpectedly diagnosed with a chronic, life-disrupting vertigo disorder? Innovation in neurotology.

That venture capitalist was Jay Lichter, Ph.D., and after learning there was no FDA-approved drug treatment for his condition, Ménière’s disease, he decided to create a company to bring drug development to neurotology. Otonomy was founded in 2008 and is dedicated to finding new drug treatments for the hugely underserved community living with balance and hearing disorders. Helping patients like Jay has been the driving force behind Otonomy, a company heading into a transformative 2020 with three clinical trial readouts: Phase 3 in Ménière’s disease, Phase 2 in tinnitus, and Phase 1/2 in hearing loss. These catalysts, together with others in the field, highlight the emerging opportunity in neurotology.
Otonomy is leading the way in neurotology
Neurotology, or the treatment of inner ear neurological disorders, is a large and untapped market for drug developers: one in eight individuals in the U.S. have moderate-to-severe hearing loss, tinnitus or vertigo disorders such as Ménière’s disease.1 With no FDA-approved drug treatments available for these conditions, the burden on patients—including social anxiety, lower quality of life, reduced work productivity, and higher rates of depression—can be significant.2, 3, 4

Joe Jimenez, Getty

Ex-No­var­tis CEO Joe Jimenez is tak­ing an­oth­er crack at open­ing a new chap­ter in his ca­reer — and that in­cludes a new board seat and a $250M start­up

Joe Jimenez is back.

The ex-CEO of Novartis has taken a board seat on Century Therapeutics, the Versant and Bayer-backed startup focused on coming up with a brand new twist on cell therapies for cancer — a field where Jimenez made his mark backing the first personalized CAR-T approved for use.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 70,700+ biopharma pros reading Endpoints daily — and it's free.

Credit: Shutterstock

Can we make the an­tibi­ot­ic mar­ket great again?

The standard for-profit model in drug development is straightforward. Spend millions, even billions, to develop a medicine from scratch. The return on investment (and ideally a tidy profit) comes via volume and/or price, depending on the disease. But the string of big pharma exits and slew of biotech bankruptcies indicate that the model is sorely flawed when it comes to antibiotics.

The industry players contributing to the arsenal of antimicrobials are fast dwindling, and the pipeline for new antibiotics is embarrassingly sparse, the WHO has warned. Drugmakers are enticed by greener pastures, compared to the long, arduous and expensive path to antibiotic approval that offers little financial gain as treatments are typically priced cheaply, and often lose potency over time as microbes grow resistant to them.

The FTC and New York state ac­cuse Mar­tin Shkre­li of run­ning a drug mo­nop­oly. They plan to squash it — and per­ma­nent­ly ex­ile him

Pharma bro Martin Shkreli was jailed, publicly pilloried and forced to confront some lawmakers in Washington riled by his move to take an old generic and move the price from $17.50 per pill to $750. But through 4 years of controversy and public revulsion, his company never backed away from the price — left uncontrolled by a laissez faire federal policy on a drug’s cost.

Now the FTC and the state of New York plan to pry his fingers off the drug once and for all and open it up to some cheap competition. And their lawsuit is asking that Shkreli — with several years left on his prison sentence — be banned permanently from the pharma industry.

Amber Saltzman (Ohana)

Flag­ship's first ven­ture of 2020 is out, and it's all about sperm

A couple years ago, Amber Salzman got a call as she was returning East full-time after a two-year stint running a gene therapy company in California.

It was from someone at Flagship Pioneering, the deep-pocketed biotech venture firm. They had a new company with a new way of thinking about sperm. It had been incubating for over a year, and now they wanted her to run it.

“It exactly fit,” Salzman told Endpoints News. “I just thought I had to do something.”

Pfiz­er ax­es 6 ear­ly to late-stage can­cer stud­ies from the pipeline — with one oth­er cut for sick­le cell dis­ease

Pfizer trimmed a group of 3 R&D programs using their PD-L1 Bavencio — partnered with Merck KGaA — in their latest pipeline cull.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 70,700+ biopharma pros reading Endpoints daily — and it's free.

UP­DAT­ED: In­cyte scores much need­ed PhI­II suc­cess — and of course it’s de­liv­ered by rux­oli­tinib

Incyte’s efforts to breathe a second life into ruxolitinib — its JAK inhibitor sold in pill form as Jakafi — has been greeted with clear, if preliminary and unsurprising, Phase III success.

Topline data from the TRuE-AD2 cements ruxolitinib’s foundational importance for Incyte, and gives analysts hope that there might yet be room for growth in a pipeline that’s suffered multiple R&D setbacks.

Stephen Hahn, AP

The FDA un­veils a new reg­u­la­to­ry frame­work to speed along gene ther­a­pies, re­ward­ing the lead­ing play­ers

Bioregnum Opinion Column by John Carroll

The emphasis at the FDA over the past 5 years or so has been on assisting drug developers as much as they can to speed up regulatory reviews and push more drugs into the market. And they are now crafting a final set of regulations aimed at flagging through a whole new generation of gene therapies in clinical testing at a rapid clip.

In a set of 6 prospective guidances posted on the FDA web site Tuesday morning, FDA commissioner Stephen Hahn committed the agency to staying flexible in handing out designations that are critical to gaining early approvals for drugs that claim to be once-and-done but don’t have anything close to the data needed to prove it.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Mike Bloomberg (AP IMAGES)

Mike Bloomberg joins a grow­ing cho­rus of De­mo­c­ra­t­ic pres­i­den­tial can­di­dates threat­en­ing to go af­ter drug patents

As the mayor of New York City, Mike Bloomberg had a few modest ideas about lowering prescription drug prices in the Big Apple that gained little traction. Now on the campaign trail on a faint hope of clinching the Democratic presidential nomination, the billionaire has some bigger plans — including one that would alter the patent system central to the biopharma business.

In a barebones drug pricing plan posted on Monday, Bloomberg came out blasting President Donald Trump for failing to deliver his promise to lower drug prices, and then making misleading claims about them. The price of over 3,000 drugs still increased at a rate five times higher than inflation in the first six months of 2019, he wrote.