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.

UP­DAT­ED: In sur­prise switch, Bris­tol-My­ers is sell­ing off block­buster Ote­zla, promis­ing to com­plete Cel­gene ac­qui­si­tion — just lat­er

Apart from revealing its checkpoint inhibitor Opdivo blew a big liver cancer study on Monday, Bristol-Myers Squibb said its plans to swallow Celgene will require the sale of blockbuster psoriasis treatment Otezla to keep the Federal Trade Commission (FTC) at bay.

The announcement — which has potentially delayed the completion of the takeover to early 2020 — irked investors, triggering the New York-based drugmaker’s shares to tumble Monday morning in premarket trading.

Celgene’s Otezla, approved in 2014 for psoriasis and psoriatic arthritis, is a rising star. It generated global sales of $1.6 billion last year, up from the nearly $1.3 billion in 2017. Apart from the partial overlap of Bristol-Myers injectable Orencia, the company’s rival oral TYK2 psoriasis drug is in late-stage development, after the firm posted encouraging mid-stage data on the drug, BMS-986165, last fall. With Monday’s decision, it appears Bristol-Myers is favoring its experimental drug, and discounting Otezla’s future.

The move blindsided some analysts. Credit Suisse’s Vamil Divan noted just days ago:

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Novotech CEO Dr. John Moller

Novotech CRO Award­ed Frost & Sul­li­van Best Biotech CRO Asia-Pa­cif­ic 2019

Known in the in­dus­try as the Asia-Pa­cif­ic CRO, Novotech is now lead CRO ser­vices provider for the grow­ing num­ber of in­ter­na­tion­al biotechs se­lect­ing the re­gion for their stud­ies.

Re­flect­ing this Asia-Pa­cif­ic growth, Novotech staff num­bers are up 20% since De­cem­ber 2018 to 600 in-house clin­i­cal re­search peo­ple across a full range of ser­vices, across the re­gion.

Novotech’s ca­pa­bil­i­ties have been rec­og­nized by an­a­lysts like Frost & Sul­li­van, most re­cent­ly with the pres­ti­gious Asia-Pa­cif­ic CRO Biotech of the year award for best prac­tices in clin­i­cal re­search for biotechs for the fifth year. See oth­er awards here.

Dean Hum. Nasdaq via YouTube

Gen­fit goes to Chi­na with a deal worth up to $228M for NASH drug

Fresh off the high of its Nas­daq IPO de­but, and the low of com­par­isons to Cymabay — whose NASH drug re­cent­ly stum­bled — Gen­fit on Mon­day un­veiled an up to $228 mil­lion deal with transpa­cif­ic biotech Terns Phar­ma­ceu­ti­cals to de­vel­op its flag­ship ex­per­i­men­tal liv­er drug — elafi­bra­nor — in Greater Chi­na.

The deal comes more than a week af­ter Gen­fit $GN­FT is­sued a fiery de­fense of its dual PPAR ag­o­nist elafi­bra­nor, when com­peti­tor Cymabay’s PPARδ ag­o­nist, se­ladel­par, fiz­zled in a snap­shot of da­ta from an on­go­ing mid-stage tri­al. The main goal at the end of 12 weeks was for se­ladel­par to in­duce a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in liv­er fat con­tent, but da­ta showed that pa­tients on the place­bo ac­tu­al­ly per­formed bet­ter.

Mike Grey. Mirum

In $86M IPO pitch, Mirum spells out plans to turn Shire dis­cards in­to or­phan liv­er drug suc­cess­es

Mike Grey doesn’t have any time to waste. Hav­ing re­gained con­trol of two liv­er dis­ease drugs from Shire and po­si­tioned them for piv­otal stud­ies — five years af­ter first hand­ing them off in a deal to sell Lu­me­na, where he was CEO — Grey is steer­ing Mirum straight in­to an IPO with a $86 mil­lion ask.

Not that Mirum has spent much of its $120 mil­lion Se­ries A cash since launch­ing last No­vem­ber. Ac­cord­ing to the S-1, the Cal­i­forn­ian biotech has burned through $23.3 mil­lion as of March, but ex­pects ex­pens­es to pick up once their clin­i­cal work gath­ers steam.

Suf­fer­ing No­var­tis part­ner Cona­tus is pack­ing it in on NASH af­ter a se­ries of un­for­tu­nate tri­al events

The NASH par­ty is over at No­var­tis-backed Cona­tus. And this time they’re turn­ing off the lights.

More than 2 years af­ter No­var­tis sur­prised the biotech in­vest­ment com­mu­ni­ty with its $50 mil­lion up­front and promise of R&D sup­port to part­ner with the lit­tle biotech on NASH — ig­nit­ing a light­ning strike for the share price — Cona­tus $CNAT is back with the lat­est bit­ter tale to tell about em­ri­c­as­an, which once in­spired con­fi­dence at the phar­ma gi­ant.

Fol­low­ing news of job cuts in Eu­ro­pean R&D ops, Sanofi con­firms it’s of­fer­ing US work­ers an 'ear­ly ex­it'

Ear­li­er in the week we learned that Sanofi was bring­ing out the bud­get ax to trim 466 R&D jobs in Eu­rope, re­tool­ing its ap­proach to car­dio as re­search chief John Reed beefed up their work in can­cer and gene ther­a­pies. And we’re end­ing the week with news that the phar­ma gi­ant has al­so been qui­et­ly re­duc­ing staff in the US, tar­get­ing hun­dreds of jobs as the com­pa­ny push­es vol­un­tary buy­outs with a fo­cus on R&D sup­port ser­vices.

Alex­ion wins pri­or­i­ty re­view for Ul­tomiris' aHUS in­di­ca­tion; FDA ex­pands ap­proval of Ver­tex's Symdeko

→ Alex­ion $ALXN has scored a speedy re­view for Ul­tomiris for pa­tients with atyp­i­cal he­molyt­ic ure­mic syn­drome (aHUS) af­ter post­ing pos­i­tive da­ta from a piv­otal study in Jan­u­ary. The drug is the rare dis­ease com­pa­ny’s shot at pro­tect­ing its block­buster blood dis­or­der fran­chise that is cur­rent­ly cen­tered around its flag­ship drug, Soliris, which is a com­ple­ment in­hibitor typ­i­cal­ly ad­min­is­tered every two weeks. Ul­tomiris has a sim­i­lar mech­a­nism of ac­tion but re­quires less-fre­quent dos­ing — every eight weeks. The de­ci­sion date has been set to Oc­to­ber 19. Late last year, Ul­tomiris se­cured ap­proval for noc­tur­nal he­mo­glo­bin­uria (PNH) pa­tients.

Bet­ter than Am­bi­en? Min­er­va soars on PhI­Ib up­date on sel­torex­ant for in­som­nia

A month af­ter roil­ing in­vestors with what skep­tics dis­missed as cher­ry pick­ing of its de­pres­sion da­ta, Min­er­va is back with a clean slate of da­ta from its Phase IIb in­som­nia tri­al.

In a de­tailed up­date, the Waltham, MA-based biotech said sel­torex­ant (MIN-202) hit both the pri­ma­ry and sev­er­al sec­ondary end­points, ef­fec­tive­ly im­prov­ing sleep in­duc­tion and pro­long­ing sleep du­ra­tion. In­ves­ti­ga­tors made a point to note that the ef­fects were con­sis­tent across the adult and el­der­ly pop­u­la­tions, with the lat­ter more prone to the sleep dis­or­der.

Gene ther­a­py biotech sees its stock rock­et high­er on promis­ing re­sults for rare cas­es of but­ter­fly dis­ease

Shares of Krys­tal Biotech took off this morn­ing $KRYS af­ter the lit­tle biotech re­port­ed promis­ing re­sults from its gene ther­a­py to treat a rare skin dis­ease called epi­der­mol­y­sis bul­losa.

Fo­cus­ing on an up­date with 4 new pa­tients, re­searchers spot­light­ed the suc­cess of KB103 in clos­ing some stub­born wounds. Krys­tal says that of 4 re­cur­ring and 2 chron­ic skin wounds treat­ed with the gene ther­a­py, the KB103 group saw the clo­sure of 5. The 6th — a chron­ic wound, de­fined as a wound that had re­mained open for more than 12 weeks — was par­tial­ly closed. That brings the to­tal so far to 8 treat­ed wounds, with 7 clo­sures.