A Hong Kong-based an­ti­body mak­er has filed for an IPO on the HKEX, mark­ing the first tru­ly home­grown com­pa­ny to take ad­van­tage of new rules that al­low pre-rev­enue biotechs to list on the stock ex­change.

Shawn Le­ung HK­IB

Founder and CEO Shawn Le­ung calls SinoMab an in­dus­try pi­o­neer in the re­gion, hav­ing start­ed out in 2002 with sup­port from Morn­ing­side — at a time the city’s lead­ers ap­peared more in­ter­est­ed in “ra­tio­nal­iza­tion” of Chi­nese med­i­cine. Le­ung, an Ox­ford-ed­u­cat­ed lo­cal who trained in the US first as a post­doc then at Im­munomedics, came up with his own frame­work for hu­man­iz­ing an­ti­bod­ies. That formed the ba­sis of SinoMab’s cur­rent pipeline, which com­pris­es a lead an­ti-CD22 drug, a BTK in­hibitor, and four oth­er pre­clin­i­cal mAbs.

With SM03, SinoMab is tar­get­ing some of the biggest in­di­ca­tions in im­munol­o­gy: rheuma­toid arthri­tis (PhI­II), sys­temic lu­pus ery­the­mato­sus (PhI) and Sjö­gren’s syn­drome (IND), in ad­di­tion to non-Hodgkin’s lym­phoma (PhII).

While Le­ung has kept the com­pa­ny’s head­quar­ters in Hong Kong’s Sci­ence Park, he’s al­so ex­pand­ed SinoMab’s foot­print, with an of­fice in Shen­zhen, a pro­duc­tion plant in Hainan and a sub­sidiary in Aus­tralia to fa­cil­i­tate clin­i­cal tri­als.

“In fu­ture, we ex­pect to lean more to­wards Chi­na be­cause we are in­creas­ing­ly see­ing that that is where the tal­ent, the mar­ket and the mon­ey are,” he said in a 2017 in­ter­view with Phar­ma Board­room. “As we are look­ing to po­si­tion our­selves for mar­ket ap­proval, we are cur­rent­ly in­vest­ing in a new man­u­fac­tur­ing plant in Chi­na and we need chan­nels to source the mon­ey for that. An ex­pand­ed pres­ence in Chi­na will al­so help us ex­pand our port­fo­lio and gain more col­lab­o­ra­tion, both lo­cal­ly and glob­al­ly.”

Le­ung, who’s al­so a mem­ber of the HKEX’s biotech ad­vi­so­ry board, adds that Hong Kong, nev­er­the­less, re­tains a cru­cial edge with re­gards to in­tel­lec­tu­al prop­er­ty:

This is not some­thing that com­pa­nies nec­es­sar­i­ly want to do in Chi­na; if an em­ploy­ee de­cides to leave with valu­able da­ta, the sheer phys­i­cal size and pop­u­la­tion den­si­ty of Chi­na mean that he can eas­i­ly dis­ap­pear with­out a trace. In Hong Kong, the in­fra­struc­ture is trust­wor­thy and ro­bust. The biotech com­mu­ni­ty is al­so rather close-knit. This is why no mat­ter how SinoMab grows in the fu­ture, pro­to­type R&D will al­ways be done here and we will on­ly go to Chi­na for the scale-up.

Those would be key sell­ing points for Hong Kong to con­tin­ue com­pet­ing with oth­er biotech hubs in Chi­na — most no­tably Shang­hai, which re­cent­ly opened up its own biotech board.

Open­ing up the stock mar­ket to biotech is go­ing to build up an en­tire biotech ecosys­tem around it. The im­pli­ca­tions go way be­yond the stock mar­ket. There will be dozens of R&D fo­cused com­pa­nies in the com­ing years as a re­sult of it.

— Brad Lon­car (@brad­lon­car) Ju­ly 8, 2019

SinoMab has ac­cu­mu­lat­ed a num­ber of Chi­nese in­vestors af­ter five ven­ture rounds. Aside from the 21.7% Le­ung holds via Skytech Tech­nol­o­gy, there are three oth­er big share­hold­ers: Forbes Cap­i­tal So­lu­tions claims 24.21%, Hainan Haiyao con­trols 18.45%, and Apri­cot has a 25.83% stake pri­or to the IPO.

So­cial im­age: Shut­ter­stock

Biohaven is at risk of making a habit of disappointing its investors. 

Late Friday the biotech $BHVN reported that the FDA had rejected its application for riluzole, an old drug that they had made over into a sublingual formulation that dissolves under the tongue. According to Biohaven, the FDA had a problem with the active ingredient used in a bioequivalence study back in 2017, which they got from the Canadian drugmaker Apotex.

Let the long battle for biosimilars in the cancer space begin.

Amgen has launched its Avastin and Herceptin copycats — licensed from the predecessors of Allergan — almost two years after the FDA had stamped its approval on Mvasi (bevacizumab-awwb) and three months after the Kanjinti OK (trastuzumab-anns). While the biotech had been fielding biosimilars in Europe, this marks their first foray in the US — and the first oncology biosimilars in the country.

→ On the same day it announced a $17.5 million Series C, life sciences and health data company Seer unveiled that it had lured former FDA commissioner and ex-CMS administrator Mark McClellan on to its board. “Mark’s deep understanding of the health care ecosystem and visionary insights on policy reform will be crucial in informing our thinking as we work to bring our liquid biopsy and life sciences products to market,” said Seer chief and founder Omid Farokhzad in a statement.

Gilead CEO Daniel O’Day’s new task hunting up a CSO for the company isn’t stopping the industry’s dominant antiviral player from doing pipeline deals.

The big biotech today snapped up 3 preclinical antiviral programs from pharma giant Novartis, with drugs promising to treat human rhinovirus, influenza and herpes viruses. We don’t know what the upfront is, but the back end has $291 million in milestones baked in.