SinoMab Bio­Science, Al­pham­ab On­col­o­gy make their way to the Hong Kong Stock Ex­change

While protests in Hong Kong are stretch­ing the lim­its of the re­gion’s econ­o­my, biotech­nol­o­gy com­pa­nies don’t ap­pear to be daunt­ed to list on the re­gion’s bourse.

Hong Kong-based SinoMab Bio­Science is look­ing to raise HK$1.75 bil­lion ($223 mil­lion) in a pub­lic of­fer­ing — while Souzou-based Al­pham­ab On­col­o­gy is gun­ning to raise up to $350 mil­lion in an IPO next month, ac­cord­ing to a Reuters re­port.

In April 2018, the Hong Kong Stock Ex­change (HKEX) re­laxed its list­ing rules to al­low pre-rev­enue biotechs with a mar­ket cap of at least HK$1.5 bil­lion ($190 mil­lion) to go pub­lic. On the first an­niver­sary of the new regime, nine biotechs (in­clud­ing 7 pre-rev­enue com­pa­nies) in­clud­ing As­cle­tis, Hua Med­i­cine and In­novent Bi­o­log­ics had raised about $4.1 bil­lion on the ex­change, ac­count­ing for rough­ly 11% of all IPO funds over the pe­ri­od.

SinoMab Bio­Science is fo­cused on im­muno­log­i­cal dis­eases. Its lead ex­per­i­men­tal drug, SM03, is a mon­o­clon­al an­ti­body that in­hibits CD22 and is be­ing de­vel­oped for use in rheuma­toid arthri­tis and oth­er im­muno­log­i­cal dis­eases such as sys­temic lu­pus ery­the­mato­sus and Sjö­gren’s syn­drome.

The com­pa­ny is of­fer­ing about 182 mil­lion shares glob­al­ly, of which 10% will be float­ed in Hong Kong at a price range be­tween HK$7.60 and HK$9.60 per share. The pub­lic of­fer­ing kicks off on Thurs­day, and the shares are sched­uled to list on No­vem­ber 12 un­der the sym­bol “SEHK.”

Mean­while, Reuters on Thurs­day re­port­ed that Al­pham­ab is look­ing to raise be­tween $250 mil­lion-$350 mil­lion by sell­ing down about a quar­ter of the com­pa­ny dur­ing the book-build­ing process, cit­ing two sources. This would give Al­pham­ab a mar­ket cap­i­tal­iza­tion of at least $1 bil­lion, the new agency re­port­ed.

The com­pa­ny in Ju­ly filed to make the leap on the HKEX, less than two months af­ter rais­ing $60 mil­lion — its sec­ond ven­ture round in a decade. It is de­vel­op­ing a slate of can­cer drugs, of which four are clin­i­cal stage. The lead­ers in its ar­se­nal are KN035, a sub­cu­ta­neous PD-L1 an­ti­body; KN046, which tar­gets both PD-L1 and CT­LA-4; and KN026, an an­ti-HER2 bis­pe­cif­ic an­ti­body.

Michel Younatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen scores a pri­or­i­ty re­view for its Alzheimer's drug ad­u­canum­ab, mov­ing one gi­ant leap for­ward in its con­tro­ver­sial quest

Biogen scored a big win at the FDA today as regulators accepted their application for the controversial Alzheimer’s drug aducanumab and gave it a priority review.

The PDUFA date is March 7, 2021.

Significantly, Biogen says it did not use its priority review voucher to win special treatment at the FDA. The agency handed that out gratis.

That’s the ideal scenario Biogen was looking for as disappointed analysts wondered aloud about the delayed application earlier in the year.

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Ryan Watts, Denali CEO

Bio­gen hands De­nali $1B-plus in cash, $1B-plus in mile­stones to part­ner on late-stage Parkin­son’s drug

Biogen is handing over more than a billion dollars cash to partner with the up-and-coming neurosciences crew at Denali on a new therapy for Parkinson’s. And the big biotech is ready to pile on more than a billion dollars more in milestones — if the alliance is a success.

For Biogen $BIIB, the move on Denali’s small molecule inhibitors of LRRK2 puts them in line to collaborate on a late-stage program for DNL151, which is scheduled to start next year.

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Alex­ion cre­ates new post for chief di­ver­si­ty of­fi­cer; Bar­ry Greene step­ping down at Al­ny­lam, Yvonne Green­street named as suc­ces­sor

Alexion has carved out a new position for chief diversity officer and filled it with an inside promotion.

Uzair Qadeer will now be responsible for their “diversity, inclusion and belonging” strategy, looking to reshape the biotech’s corporate culture. A veteran of Deloitte and Bristol Myers Squibb, Qadeer was working on executive coaching and helping create the diversity program he now leads.

Covid-19 roundup: Pfiz­er teams with Gilead on remde­si­ivr; Japan, Brazil, Switzer­land, In­dia get vac­cines

Pfizer has joined the list companies helping Gilead manufacture remdesivir. The pharma giant announced today they signed a multi-year agreement to provide Gilead with contract manufacturing services at their McPherson, Kansas plant. The deal is part of a broad effort by Gilead to scale up the drug, the only currently authorized therapy for Covid-19, to 2 million doses this year.

That effort now includes 40 different companies on 3 continents, according to a press release the biotech put out yesterday, not including the generic drugmakers the company has allowed to produce the anti-viral for low and middle-income countries. Dozens of state governments, though, have said those efforts have not been extensive enough to keep up with demand and have called upon the federal government to sidestep Gielad’s patents and begin scaling the drug itself.  – Jason Mast

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President Trump (AP Images)

UP­DAT­ED: FDA takes the lead on defin­ing es­sen­tial un­der Trump's 'Buy Amer­i­can' ex­ec­u­tive or­der — as phar­ma warns of sup­ply chain dis­rup­tion

President Donald Trump has signed an executive order detailing how the federal government should help on-shore drug manufacturing — and the FDA will play a central role.

The agency now has three months to draw up the list of “essential medicines, medical countermeasures, and their critical inputs” that the US must have available at all times. Various departments and agencies are then directed to buy these drugs and their ingredients from American manufacturers.

In sur­pris­ing set­back, com­bo of Roche’s Tecen­triq and chemo fails to help pa­tients with triple-neg­a­tive breast can­cer

Roche broke ground last year when they secured the first FDA approval for a checkpoint therapy in triple-negative breast cancer, a notoriously difficult-to-treat indication that has been passed over by the wave of targeted therapies.

Now, though, doctors are puzzling over why a combination of drugs meant to make that therapy more potent instead appeared to make it less effective.

Roche said Thursday that in a Phase III trial, combining their PD-1/L1 checkpoint therapy Tecentriq with the chemotherapy paclitaxel, did not significantly improve progression-free survival for patients with locally advanced or metastatic triple-negative breast cancer over giving those patients chemotherapy alone. In fact, patients on the Tecentriq-chemo arm had lower overall survival than patients on chemo, although the drugmaker cautioned that the trial was not powered for that endpoint and the data were immature.

Sean Nolan and RA Session II

Less than 3 months af­ter launch, the AveX­is crew’s Taysha rais­es $95M Se­ries B. Is an IPO next?

The old AveXis team is moving quickly in Dallas.

Three months ago, they launched Taysha with $30 million in Series A funding and a pipeline of gene therapies out of UT Southwestern. Now, they’ve announced an oversubscribed $95 million Series B. And the biotech is declining all interview requests on the news, the kind of broad silence that can indicate an IPO is in the pipeline.

Biotechs, including those relatively fresh off launch, have been going public at a frenzy since the pandemic began. Investors have showed a willingness to put upwards of $200 million to companies that have yet to bring a drug into the clinic. Still, if Taysha were to go public in the near future, it would be perhaps the shortest path from launch to IPO in recent biotech memory.

Ben Dake (Source: Aerovate)

RA Cap­i­tal-backed Aerovate launch­es with $72.6M to treat PAH with a re­pur­posed can­cer med

The landmark cancer drug imatinib has been on the market since 2001, first sold by Novartis as Gleevec and in recent years as a generic. Now, a new Boston biotech is aiming to repurpose the drug as a treatment for pulmonary arterial hypertension.

Aerovate emerged from stealth Thursday and announced a $72.6 million Series A, which will be used to develop and run trials for its candidate AV-101 — a dry powder version of imatinib meant to be used with an inhaler. The company emerged from RA Capital’s incubator and funding was led by Sofinnova.

President Trump speaks with members of the media before boarding Marine One (AP Images)

'Oc­to­ber is com­ing,' and every­one still wants to know if a Covid-19 vac­cine will be whisked through the FDA ahead of the elec­tion

Right on the heels of a lengthy assurance from FDA commissioner Stephen Hahn that the agency will not rush through a quick approval for a Covid-19 vaccine, the President of the United States has some thoughts on timing he’d like to share.

In an exchange with Fox News’ Geraldo Rivera on Thursday, President Trump allowed that a vaccine could be ready to roll “sooner than the end of the year, could be much sooner.”

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