Just a few days af­ter Ab­b­Vie went all in on a Covid-19 an­ti­body, its part­ner has of­fi­cial­ly wrapped its IPO.

Jing­song Wang

List­ing on the Hong Kong Stock Ex­change, Har­bour Bio­Med has raised $221 mil­lion with help from nine cor­ner­stone in­vestors: Black­Rock Fund, HBM Health­care, Hill­house Cap­i­tal, Hud­son Bay Cap­i­tal, Oc­ta­gon In­vest­ments, An­lan Fund, Leg­end Cap­i­tal, Or­biMed and 3W Cap­i­tal.

The new in­jec­tion adds to over $300 mil­lion the com­pa­ny — which has of­fices in both Suzhou, Chi­na and Cam­bridge, MA — has ac­crued in four years.

With a fo­cus on im­munol­o­gy and on­col­o­gy, Har­bour Bio­Med has said it will main­ly in­vest the pro­ceeds on three an­chor as­sets: ba­to­climab, the an­ti­body hit­ting the neona­tal Fc re­cep­tor for a range of au­toim­mune and in­flam­ma­to­ry dis­or­ders; tan­fan­er­cept, a TNF-α drug for dry eye dis­ease; and HBM4003, a CT­LA4 in­hibitor.

The first two are in reg­is­tra­tional tri­als while the third is just en­ter­ing the clin­ic.

But the biggest val­i­da­tion of its an­ti­body dis­cov­ery plat­form might have come ear­li­er this year with 47D11, a pro­gram orig­i­nal­ly de­vel­oped for SARS-CoV-1. Since it tar­gets a re­gion on the spike pro­tein that’s con­served on SARS-CoV-2, CEO Jing­song Wang told End­points News, Har­bour Bio­Med, the Nether­lands’ Utrecht Uni­ver­si­ty and Eras­mus Med­ical Cen­ter worked to­geth­er to test it pre­clin­i­cal­ly for the new coro­n­avirus.

Ab­b­Vie jumped on board in June, help­ing boot up a small Phase I tri­al in the US that start­ed just last week. On Mon­day the phar­ma gi­ant ex­er­cised its op­tion to li­cense the whole pro­gram for de­vel­op­ment and com­mer­cial­iza­tion.

The fate of the pro­gram will test Har­bour’s promis­es to de­liv­er glob­al­ly com­pet­i­tive next-gen an­ti­body drugs — many of which are aimed at the same tar­gets as es­tab­lished ther­a­pies — through a com­bi­na­tion of li­cens­ing and in-house re­search.

As Congress considers whether to adopt sweeping new legislation to lower prescription drug prices across the board, the Kaiser Family Foundation is out with a new report on Monday showing how a more targeted approach on a subset of drugs might be a more efficient way to save government funds.

“This analysis shows that Medicare Part D and Part B spending is highly concentrated among a relatively small share of covered drugs, mainly those without generic or biosimilar competitors,” wrote Juliette Cubanski, deputy director of the program on Medicare policy at KFF, and Tricia Neuman, SVP of KFF. “Focusing drug price negotiation or reference pricing on a subset of drugs that account for a disproportionate share of spending would be an efficient use of administrative resources, though it would also leave some potential savings on the table.”

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It was another busy week in the biotech IPO market as the second quarter continues to churn out significant investment into the sector.

Recursion led the way with a $436 million raise on Friday, pricing its IPO at $18, the high end of its range. Our own John Carroll went in depth on that raise over the weekend. Also on Friday, preclinical cancer biotech Biomea Fusion debuted with a $153 million raise priced at its own high end of $17 per share. The two companies helped push the combined IPO raise for 2021 to nearly $5.5 billion.

It’s always a surprise when a court has to step in to tell the FDA that it erred in performing one of its main duties: classifying whether a medical product is drug or a device.

But that’s what the US Court of Appeals for the District of Columbia did on Friday, making clear to the world’s top drug regulator that Genus Medical Technologies’ contrast agent barium sulfate (also known as Vanilla SilQ) should not be considered a drug, as the FDA had said, but a medical device.

Seagen is riding the wave of two new priority reviews straight to the FDA.

The Bothell, WA-based biotech and their partners at Astellas announced Monday that two supplemental BLAs for Padcev had been accepted by US regulators. FDA has set Aug. 17 as the PDUFA date for the reviews.

“With our recent regulatory submissions, we intend to provide the highest level of clinical evidence supporting Padcev use — overall survival data from a randomized Phase III trial — and expand availability in multiple countries where there is unmet medical need,” said Astellas oncology chief Andrew Krivoshik.