Hong Kong ex­change picks up steam with two biotech IPOs from In­novent, Mi­cuRx

Amid the IPO fren­zy tak­ing place on the Nas­daq, the stock ex­change in Hong Kong has qui­et­ly caught up with two ap­pli­ca­tions at the end of last week — the third and fourth com­pa­nies to try the route since the city opened up to pre-rev­enue biotechs want­i­ng to list.

Michael Yu

The first can­di­date is In­novent Bi­o­log­ics, a 7-year-old biotech uni­corn long ru­mored to be an­gling for a pub­lic list­ing and hand­ed $150 mil­lion in a Se­ries E crossover round weeks ago. They were joined by fel­low Shang­hai-based drug­mak­er Mi­cuRx Phar­ma, which is look­ing for some help pow­er­ing through var­i­ous stud­ies for its drugs treat­ing mul­ti­ple drug re­sis­tant in­fec­tions.

In an un­usu­al chair­man’s let­ter that starts off the ap­pli­ca­tion doc­u­ment, In­novent founder and CEO Michael Yu re­flect­ed on the found­ing phi­los­o­phy of the com­pa­ny:

The re­al­i­ty is that there is a huge gap be­tween Chi­na’s bio­phar­ma­ceu­ti­cal in­dus­try and in­ter­na­tion­al stan­dards. Chi­na’s bio­phar­ma­ceu­ti­cal pro­duc­tion ca­pac­i­ty is less than one-fifti­eth of that of the Unit­ed States, and not even one-tenth of that of South Ko­rea. Among the top ten best-sell­ing drugs in the world, eight are bi­o­log­ics and five are mon­o­clon­al an­ti­body drugs, while Chi­na’s best­selling drugs are still most­ly chem­i­cal drugs and tra­di­tion­al Chi­nese med­i­cines. Im­port­ed drugs dom­i­nate Chi­na’s an­ti­body drug mar­ket, and for most Chi­nese pa­tients, these life-sav­ing drugs are of­ten un­af­ford­able and out of reach.

His an­swer to that need has now grown to a 510-strong com­pa­ny with a pipeline of 17 drugs, with sev­en in clin­i­cal de­vel­op­ment and four in Phase III tri­als.

Sin­til­imab, a PD-1 in­hibitor cur­rent­ly un­der pri­or­i­ty re­view in Chi­na, is the star here; In­novent is al­so look­ing to start ear­ly-stage tri­als of the drug in the US while us­ing it as a base for two oth­er as­sets they are co-de­vel­op­ing with Eli Lil­ly.

As is stan­dard in these ap­pli­ca­tions, In­novent redact­ed any­thing that could re­mote­ly give the IPO away, so we don’t know whether it is in­deed seek­ing $300 mil­lion to $500 mil­lion, as Reuters pre­vi­ous­ly re­port­ed. What we do know is that sin­til­imab, to­geth­er with three biosim­i­lars — go­ing af­ter block­busters like Avastin, Rit­ux­an and Hu­mi­ra — will claim most of the raise, from tri­als and reg­is­tra­tion fil­ings to com­mer­cial­iza­tion.

Great Biono For­tune, a coali­tion of In­novent em­ploy­ees, owns the largest chunk of stock at 10.22%, fol­lowed by Lil­ly Asia Ven­tures and F-Prime Cap­i­tal, which have 8.86% each.

Zhengyu Yuan

Mi­cuRx, mean­while, has kept its am­bi­tions tight­ly un­der wraps. CEO Zhengyu Yuan found­ed the com­pa­ny af­ter an R&D stint at Vi­curon (merged with Pfiz­er) with the help of then-col­league Mike Gordeev, now CSO.

The com­pa­ny, which has teams in both San Fran­cis­co and Shang­hai, closed a $15 mil­lion fi­nanc­ing last year to com­plete a Phase III for its lead oral an­tibi­ot­ic, con­te­zol­id (MRX-1). The bulk of the raise will go to­ward MRX-4, a pro­drug for­mu­la­tion of MRX-1 dubbed con­te­zol­id ace­fos­amil. While the drug is on­ly be­gin­ning hu­man stud­ies in Chi­na, it’s ready to roll with a Phase II in the US lat­er in the year. Mi­cuRx will al­so in­vest some cash in­to a pre­clin­i­cal polymicin an­tibi­ot­ic backed by CARB-X.

A BVCF sub­sidiary and Morn­ing­side are the largest share­hold­ers, con­trol­ling 29.12% and 26.50% re­spec­tive­ly.

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

President Trump walks past HHS secretary Alex Azar (Getty Images)

Azar falls in line un­der Trump again. Ex­perts say he's re­in­forc­ing a dark sig­nal sent to the FDA

In the latest incident where Alex Azar has steadfastly taken the side of President Donald Trump over that of the FDA, the HHS secretary was noncommittal this morning when asked if he supports the attempt by his subordinates at the FDA to strengthen guidelines for a vaccine EUA.

Appearing on NBC’s Today Show, the HHS secretary muddied the waters, stating that the guidance that matters is the one that is “actually already out there.”

CDC’s Robert Redfield, NIAID’s Anthony Fauci, Admiral Brett Giroir at HHS, and FDA’s Stephen Hahn prepare to testify at a House hearing on June 23 (Getty)

'Ex­treme­ly po­lit­i­cal' — Trump neuters FDA's at­tempt to strength­en vac­cine EUA

Stephen Hahn went before a Senate committee Wednesday and declared he’s fighting. “Every one of the decisions we have reached has been made by career FDA scientists based on science and data, not politics,” he exclaimed, adding that “FDA will not permit any pressure from anyone to change that. I will fight for science.”

A few hours later, he was undermined by President Donald Trump when a reporter asked if he was okay with stricter vaccine guidelines that the FDA was said to be cooking up. “That has to be approved by the White House. We may or may not approve it. That sounds like a political move,” he decided.

On­ly five months af­ter a Se­ries A launch, Taysha goes pub­lic with $157M IPO

As has been the trend in 2020, Taysha Gene Therapies has become the latest biotech to make a quick ascent from a small, privately-funded company to enjoying its very own Nasdaq ticker.

The Dallas-based biotech raised $157 million for its IPO after pricing shares at $20 apiece Thursday, the high-point of its expected range. Initially pegging $100 million in financing, Taysha offered a little less than 8 million shares and will trade under the $TSHA symbol.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,500+ biopharma pros reading Endpoints daily — and it's free.

New York governor Andrew Cuomo (AP Images)

An­drew Cuo­mo says New York will un­der­take its own vac­cine re­view process, and wouldn’t rec­om­mend trust­ing the fed­er­al gov­ern­ment

The concerns keep mounting over President Donald Trump’s politicization of the FDA and other federal agencies guiding the development of a safe and effective vaccine. And today, the telegenic New York governor Andrew Cuomo appeared to introduce even more politics into the matter — latest in an ongoing series of incidents that have cast the proudly independent FDA in starkly political terms.

During his daily press conference Cuomo said that the state will review any coronavirus vaccines approved by the federal government, citing a lack of trust of the Trump administration. The announcement comes one day after Trump accused the FDA of making an “extremely political” move in proposing stricter vaccine guidance.

Covid-19 roundup: Op­er­a­tion Warp Speed's 7th vac­cine is live at­ten­u­at­ed; Small biotech touts big suc­cess where gi­ants have failed

Operation Warp Speed is stacking its vaccine portfolio with a “TBD” new candidate: a live attenuated vaccine that can be administered in a single dose, potentially as an oral formulation rather than an injection.

Sound familiar?

That could be because the unannounced candidate appears to match the profile of an inoculation being developed by Merck, according to Bloomberg, which first reported the development based on a presentation by Moncef Slaoui.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,500+ biopharma pros reading Endpoints daily — and it's free.

David Berry (Flagship)

Flag­ship's next big tech­no­log­i­cal bet? The cloud

Earlier this month, Flagship announced their big bet on the software half the industry is talking about, launching the AI and machine learning startup. Now, they and a couple other investors are gambling $100 million on a software that much of the public generally thinks of as a cool, IT afterthought: cloud computing.

The idea, says founder and Flagship partner David Berry, is one of scale: The sheer magnitude of biological data that you can store on cloud technology is unprecedented. And that size, when leveraged properly, can allow you to ask questions and form insights that are similarly unprecedented.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,500+ biopharma pros reading Endpoints daily — and it's free.

PhII Alzheimer's fail­ure deals new blow to Roche, AC Im­mune — but the tau hy­poth­e­sis is far from dead

The leading anti-tau antibody has failed its first Phase II testing, casting a shadow on a popular target (just trailing amyloid beta) for Alzheimer’s disease.

Roche and AC Immune are quick to acknowledge disappointment in the topline readout, which suggested that semorinemab did not reduce cognitive decline among patients with early Alzheimer’s disease, who are either just starting to have symptoms or have mild manifestations.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,500+ biopharma pros reading Endpoints daily — and it's free.

Covid-19 roundup: J&J be­gins piv­otal Phase III tri­al for vac­cine; Con­tro­ver­sial hu­man chal­lenge tri­als to be­gin in Lon­don — re­port

Johnson & Johnson announced it’s beginning a pivotal Phase III trial for its Covid-19 candidate, JNJ-78436735 — the first single-dose vaccine in this stage.

The Phase III trial, dubbed ENSEMBLE, will enroll 60,000 patients worldwide, making it the largest Phase III study of a Covid-19 vaccine to date. J&J said the candidate achieved positive interim results in a Phase I/IIa study, which will be published “imminently.” There’s a possibility that the first batches will be ready for potential emergency use in early 2021, according to the company.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,500+ biopharma pros reading Endpoints daily — and it's free.