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.

Il­lus­tra­tion: Sky­scrap­ers in Hong Kong. Shut­ter­stock

Pi­o­neer­ing Click Chem­istry in Hu­mans

Reimagining cancer treatments

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, which is nearly one in six deaths. Recently, we have seen incredible advances in novel cancer therapies such as immune checkpoint inhibitors, cell therapies, and antibody-drug conjugates that have revamped cancer care and improved survival rates for patients.

Despite this significant progress in therapeutic targeting, why are we still seeing such a high mortality rate? The reason is that promising therapies are often limited by their therapeutic index, which is a measure of the effective dose of a drug, relative to its safety. If we could broaden the therapeutic indices of currently available medicines, it would revolutionize cancer treatments. We are still on the quest to find the ultimate cancer medicine – highly effective in several cancer types, safe, and precisely targeted to the tumor site.

Justin Klee (L) and Joshua Cohen, Amylyx co-CEOs (Cody O'Loughlin/The New York Times; courtesy Amylyx)

Ad­vo­cates, ex­perts cry foul over Amy­lyx's new ALS drug, cit­ing is­sues with price, PhI­II com­mit­ment

Not 24 hours after earning the first ALS drug approval in five years, Amylyx Pharmaceuticals’ Relyvrio is already drawing scrutiny. And it’s coming from multiple fronts.

In an investor call Friday morning, Amylyx revealed that it would charge about $158,000 per year, a price point that immediately drew backlash from ALS advocates and some outside observers. The cost reveal had been highly anticipated in the immediate hours after Thursday evening’s approval, though Amylyx only teased Relyvrio would cost less than previously approved drugs.

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Land­mark Amy­lyx OK spurs de­bate; Some... pos­i­tive? Alzheimer's da­ta; Can­cer tri­al bot­tle­neck; Sanofi's CRISPR bet; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

After brief stops in Paris and Boston, John Carroll and the Endpoints crew are staying on the road in October with their return for a live/streaming EUBIO22 in London. The hybrid event fireside chats and panels on mRNA, oncology and the crazy public market. We hope you can join him there.

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Joshua Cohen (L) and Justin Klee, Amylyx co-CEOs

Up­dat­ed: Af­ter long and wind­ing road, FDA ap­proves Amy­lyx's ALS drug in vic­to­ry for pa­tients and ad­vo­ca­cy groups

For just the third time in its 116-year history, the FDA has approved a new treatment for Lou Gehrig’s disease, or ALS.

US regulators gave the thumbs-up to the drug, known as Relyvrio, in a massive win for patients and their families. The approval, given to Boston-area biotech Amylyx Pharmaceuticals, comes after two years of long and contentious debates over the drug’s effectiveness between advocacy groups and FDA scientists, following the readout of a mid-stage clinical trial in September 2020.

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Nooman Haque, head of life sciences and healthcare at Silicon Valley Bank, and John Carroll

I’m head­ed to Lon­don soon for #EU­BIO22. Care to join me?

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

Hui Shao, YS Biopharma president and CEO (L) and Yi Zhang, founder and chairman

Chi­na’s Yisheng­Bio is go­ing to Nas­daq, mak­ing the tran­si­tion via $230M SPAC ma­neu­ver

After attempting to make it on the HKEX last year, a Chinese biopharma is finally taking the once-flashy SPAC route to get on the Nasdaq.

YishengBio — which will be renamed YS Biopharma, per a Thursday statement — will be combining with Hong Kong-based Summit Healthcare Acquisition Corp, currently listed on Nasdaq under the ticker $SMIH after launching on the stock exchange last year. If everything goes to plan, the merger will be finished in Q1 next year.

#AAO22: J&J’s first look at com­mon eye dis­ease port­fo­lio pads the case for PhII of gene ther­a­py

CHICAGO — While the later-stage drug developers in the geographic atrophy field are near the finish line, Johnson & Johnson’s Janssen is taking a more deliberate route, with a treatment that it hopes to be a one-time fix.

The Big Pharma will take its Hemera Biosciences-acquired gene therapy into a Phase II study later this year in patients with GA, a common form of age-related macular degeneration that impacts about five million people worldwide. To get there, Janssen touted early-stage safety data at the American Academy of Ophthalmology annual conference Saturday morning, half a day after competitors Apellis and Iveric Bio revealed their own more-detailed Phase III analyses.

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George Church (courtesy EnPlusOne BioSciences)

George Church, Wyss sci­en­tists and North­pond chal­lenge con­ven­tion­al RNA man­u­fac­tur­ing with new biotech

RNA medicine has been at the forefront for the past few years, with the first RNA silencing therapy approved in 2018, and mRNA Covid vaccines following after. But flying under the radar has been the process of actually making RNA for these treatments.

That’s what Daniel Wiegand and Jonathan Rittichier have been working on in George Church’s lab for the past six years.

Friday morning, they unveiled EnPlusOne Biosciences, a biotech built on their RNA synthesis platform. Wiegand will serve as the Watertown, MA-based biotech’s CEO, and Rittichier will be CSO. And no different from his other startups, Church will be acting as scientific advisor. Its fourth co-founder, Dan Ahlstedt, joined through a Harvard Business School program, and will be COO.

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Up­dat­ed: Al­ny­lam re­in­forces APOL­LO-B patisir­an da­ta be­fore head­ing to the FDA

Weeks after uncorking some mostly positive data for patisiran in transthyretin-mediated (ATTR) amyloidosis with cardiomyopathy, Alnylam is bolstering its package with new exploratory and subgroup data before shipping it off to regulators.

The RNAi drug maintained “generally consistent” benefits in efficacy and quality of life across several prespecified subgroups at month 12, Alnylam announced on Friday afternoon, including age, baseline tafamidis use, ATTR amyloidosis type, baseline six-minute walk test score and others.

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