Is HKEX ready to re­turn to biotech busi­ness? In­no­Care tests wa­ters with hopes to fetch $257M in IPO

The Covid-19 out­break may have forced In­no­Care Phar­ma to post­pone in­vestor meet­ings ahead of its pub­lic de­but on the Hong Kong Stock Ex­change, but it hasn’t stopped the biotech from car­ry­ing on with an IPO that could bring in $257 mil­lion (HKD1.993 bil­lion) at the mid­point.

Jas­mine Cui

The re­al test be­gins to­day. In­vestors now have five days to file their share ap­pli­ca­tions be­fore the fi­nal ex­pect­ed price is de­ter­mined next Mon­day and an­nounced next Fri­day. Trad­ing is ex­pect­ed to com­mence the week af­ter.

Hav­ing can­celled plans to meet po­ten­tial in­vestors face-to-face, In­no­Care re­port­ed­ly host­ed vir­tu­al talks to gauge in­ter­est in its of­fer­ing.

Re­cep­tion to In­no­Care’s float will il­lus­trate whether biotech IPOs in Hong Kong are in­deed, as in­de­pen­dent in­vestor Brad Lon­car puts it, “get­ting back in gear.” Days ago Im­munotech Bio­pharm al­so sub­mit­ted an ap­pli­ca­tion to list, pre­sum­ably be­cause their orig­i­nal fil­ing from last Sep­tem­ber has lapsed.

There’s no sign that the epi­dem­ic caused by SARS-CoV-2, which ap­pears to be dy­ing down in Chi­na even as it rav­ages the world, would im­pact its day-to-day op­er­a­tions just yet, the com­pa­ny added in an up­dat­ed fil­ing.

To min­i­mize the im­pact of the COVID-19 out­break, we have al­so im­ple­ment­ed com­pa­ny-wide self-pro­tec­tion poli­cies for em­ploy­ees to ei­ther work re­mote­ly or on­site with pro­tec­tive masks and san­i­ti­za­tion. We cur­rent­ly do not an­tic­i­pate any ma­te­r­i­al de­vi­a­tion from our com­mer­cial­iza­tion plans, as such plans are based up­on CDE ap­proval time­line and noth­ing has come to our at­ten­tion at this stage that the CDE re­view process is ex­pe­ri­enc­ing de­lays.

Yigong Shi

Cen­tered around can­cer and au­toim­mune drugs — with an eye to be first- or best-in-class — their pitch is rem­i­nis­cent of a num­ber of up-and-com­ing biotech star­tups in Chi­na. But with Mer­ck vet Jas­mine Cui as CEO and pres­ti­gious aca­d­e­m­ic Yigong Shi as pres­i­dent of the sci­en­tif­ic ad­vi­so­ry board, In­no­Care is bet­ting that they can do it bet­ter than most.

Cui im­port­ed most of her core team, as well as a port­fo­lio of as­sets, from Bio­Duro, a drug dis­cov­ery ser­vices com­pa­ny owned by PPD, where she was first re­cruit­ed as CSO then pro­mot­ed to CEO. But with the ex­cep­tion of the lead drug, ore­labru­ti­nib, the oth­er drug can­di­dates were all dis­cov­ered in-house, the com­pa­ny wrote in its fil­ing.

In four years the dis­cov­ery team has swelled to 100 staffers, plus 60 re­spon­si­ble for clin­i­cal de­vel­op­ment.

Ren­bin Zhao

With ore­labru­ti­nib, a BTK in­hibitor, In­no­Care is en­ter­ing a space dom­i­nat­ed by gi­ants. While J&J and Ab­b­Vie cur­rent­ly mar­ket the on­ly such drug in Chi­na (Im­bru­vi­ca), As­traZeneca’s Calquence and BeiGene’s Brukin­sa are both in bet­ter po­si­tions to catch up with reg­u­la­to­ry ap­provals in the US and else­where.

Soon af­ter In­no­Care first filed an IPO ap­pli­ca­tion in Hong Kong, the Na­tion­al Med­ical Prod­uct Ad­min­is­tra­tion ac­cept­ed an NDA for ore­labru­ti­nib in re­lapsed/re­frac­to­ry chron­ic lym­pho­cyt­ic leukemia or small lym­pho­cyt­ic lym­phoma (CLL/SLL). In re­cent days, reg­u­la­tors al­so added the R/R man­tle cell lym­phoma (MCL) in­di­ca­tion to the queue.

Half of the pro­ceeds will go to­ward the ore­labru­ti­nib pro­gram, the com­pa­ny wrote, bol­ster­ing every­thing from clin­i­cal tri­als to a com­mer­cial man­u­fac­tur­ing fa­cil­i­ty in Guangzhou to a field team com­pris­ing 80 to 90 sales reps.

Cui and Ren­bin Zhao, In­no­Care’s ex­ec­u­tive di­rec­tor of bi­ol­o­gy and clin­i­cal de­vel­op­ment strat­e­gy, each hold large chunks of the stock — which would stand at 8.85% and 12.07% post-IPO even if the over-al­lot­ment op­tion is ful­ly ex­er­cised. Hebert Chan, a found­ing part­ner of Ad­van­tech Cap­i­tal, would be in for 12.52% in that sce­nario. Oth­er share­hold­ers in­clude Sin­ga­pore’s sov­er­eign wealth fund GIC (9.26%), Vi­vo Cap­i­tal (6.60%), TMF (10.59%) and LVC En­ti­ties (9.38%).

So­cial: AP Im­ages

Tesla and SpaceX founder Elon Musk gestures to the audience after being recognized by President Trump following the successful launch of a Falcon 9 rocket at the Kennedy Space Center. (via Getty Images)

Tes­la chief Elon Musk teams up with Covid-19 play­er Cure­Vac to build 'R­NA mi­cro­fac­to­ries'

Elon Musk has joined the global tech crusade now underway to revolutionize vaccine manufacturing — now aimed at delivering billions of doses of a new mRNA vaccine to fight Covid-19. And he’s cutting right to the front.

In a late-night tweet Wednesday, the Tesla chief announced:

Tesla, as a side project, is building RNA microfactories for CureVac & possibly others.

That’s not a lot to go on. But the tweet comes a year after Tesla’s German division in Grohmann and CureVac filed a patent on a “bioreactor for RNA in vitro transcription, a method for RNA in vitro transcription, a module for transcribing DNA into RNA and an automated apparatus for RNA manufacturing.” CureVac, in the meantime, has discussed a variety of plans to build microfactories that can speed up the whole process for a global supply chain.

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George Yancopoulos (Regeneron)

UP­DAT­ED: Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

Typically, the commencement speech at Yorktown Central School District in Westchester — like most high schools — is an opportunity to encourage students to face the future with confidence and hope. Regeneron president and co-founder George Yancopoulos, though, went a different route.

In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

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Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

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Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

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Now that Boehringer Ingelheim’s bet on contract manufacturing in China has paid off, the German drugmaker is anteing up more to get into the research game.

Boehringer has set aside $507.9 million (€451 million) for a new External Innovation Hub to be built in Shanghai over five years. The site will become one of its “strategic pillars” as the team strives to get 71 approvals — either for new products or indications — by 2030, said Felix Gutsche, president and CEO of Boehringer Ingelheim China.

Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

Seven months after Astellas shelled out $3 billion to acquire the gene therapy player Audentes, the biotech company’s lead program has been put on hold following the death of 2 patients taking a high dose of their treatment. And there was another serious adverse event recorded in the study as well, with a total of 3 “older” patients in the study affected.

The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

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Vas Narasimhan, Novartis CEO (Patrick Straub/​EPA-EFE/​Shutterstock)

No­var­tis pays $678M for kick­back scheme as Vas Narasimhan tries to dis­tance phar­ma gi­ant from shady be­hav­ior

Novartis has reached another large settlement to resolve misconduct allegations, agreeing to pay more than $678 million to settle claims that it had spent hundreds of millions of dollars on lavish dinners, so-called speaking fees and expensive alcohol “that were nothing more than bribes” to get doctors to prescribe Novartis medications.

The top-shelf alcohol and lavish meals included a $3,250 per person night at Nobu in Dallas, a $672-per person dinner at Washington DC’s Smith & Wollensky and a $314 per person meal at Sushi Roku in Pasadena, according to the Justice Department complaint. There were at least 7 trips to Hooters and fishing trips in Alaska and off the Florida coast. Each of these events were supposed to be “speaker programs” where doctors educated other doctors on a drug, but the DOJ alleged many were “bogus” wine-and-dine events where the drug was barely mentioned, if at all.  (“Nobody presented slides on the fishing trips,” the complaint says.)

No­vavax snags Ben Machielse for CMC and pro­motes a trio of staffers; Mar­ty Du­vall lands an­oth­er CEO post at On­copep­tides

Novavax has been making waves recently by securing a $384 million commitment from CEPI to cover R&D and manufacturing for its Covid-19 vaccine while also spending $167 million on a 150,000 square-foot facility. The Maryland biotech continues to shore up its leadership team as well, bringing in Ben Machielse as their EVP of CMC just a couple weeks after nabbing AstraZeneca vet Filip Dubrovsky as their new CMO. Machielse was president and CEO of Vtesse from 2014-17, and before that, he also spent more than 11 years at MedImmune and was EVP of operations for the back half of his tenure.

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Dan Gold, MEI Pharma CEO

De­vel­op­ment part­ners at MEI, Helsinn dump a high-risk PhI­II AML study af­ter con­clud­ing it would fail sur­vival goal

Four years after Switzerland’s Helsinn put $25 million of cash on the table for an upfront and near-term milestone to take MEI Pharma’s drug pracinostat into a long-running Phase III trial for acute myeloid leukemia, the partners are walking away from a clinical pileup.

The drug — an HDAC inhibitor — failed to pass muster during a futility analysis, as researchers concluded that pracinostat combined with azacitidine wasn’t going to outperform the control group in the pivotal.

No­var­tis los­es biosim­i­lar ap­peal as court up­holds a 31-year mo­nop­oly by Am­gen's En­brel

A new court ruling has strengthened Amgen’s grip on the IP estate around Enbrel, keeping biosimilars of the autoimmune and inflammatory drug at bay until 2029.

Novartis, the patent challenger, isn’t throwing in the towel yet. In a statement noting the failed appeal, its generics division Sandoz noted its reviewing options, “including potential appeal to US Supreme Court.”

It’s been almost four years since the FDA approved Erelzi, Sandoz’s copycat version of Enbrel. While sales of the Pfizer-partnered drug in the US — the market Amgen is in charge of — have dipped slightly during that time, it remains a solid megablockbuster with 2019 revenue slightly above $5 billion.