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.

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain drugs; 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.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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Seagen interim CEO Roger Dansey and Daiichi Sankyo CEO Sunao Manabe

Paving the way for Mer­ck­'s buy­out, Seagen los­es ar­bi­tra­tion dis­pute with Dai­ichi over ADC tech

As Seagen awaits a final buyout offer from Merck that could be in the territory of $40 billion, Seagen revealed Friday afternoon that it lost an arbitration dispute with Daiichi Sankyo relating to the companies’ 2008 collaboration around the use of antibody-drug conjugate (ADC) technology.

But that loss likely won’t matter much when it comes to Merck’s deal.

After breaking off its pact with Daiichi in mid-2015, the two companies battled over “linker” tech — a chemical bridge between an ADC’s antibody component and the cytotoxic payload — that Seagen claims Daiichi would improve upon and implement in its current generation of ADCs.

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Tony Coles, Cerevel CEO

Cerev­el takes the pub­lic of­fer­ing route, with a twist — rais­ing big mon­ey thanks to ri­val da­ta

As public biotechs seek to climb out of the bear market, a popular strategy to raise cash has been through public offerings on the heels of positive data. But one proposed raise Wednesday appeared to take advantage not of a company’s own data, but those from a competitor.

Cerevel Therapeutics plans to raise $250 million in a public offering and another $250 million in debt, the biotech announced Wednesday afternoon, even though it did not report any news on its pipeline. However, the move comes days after rival Karuna Therapeutics touted positive Phase III data in schizophrenia, a field where Cerevel is pursuing a similar program.

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House pass­es his­toric drug pric­ing re­forms, lin­ing up decades-in-the-mak­ing win for Biden and De­moc­rats

The US House of Representatives today voted along party lines (all Dems voted for it), 220-207 to pass new, wide-ranging legislation that will allow Medicare drug price negotiations for the first time ever, and cap seniors’ drug expenses to $2,000 per year and seniors’ insulin costs at $35 per month.

Setting up a major victory for President Joe Biden, representatives returned from their summer recess to pass the Inflation Reduction Act, even as many noted the bill would only modestly reduce inflation.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.