In a first, HKEX re­ceives IPO pitch from lo­cal biotech look­ing to make it big in crowd­ed an­ti­bod­ies field

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.

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

Com­mu­ni­cat­ing the val­ue of pre­ci­sion med­i­cine

By Natasha Cowan, Content Marketing Manager at Blue Latitude Health.
Many stakeholders are confused by novel precision medicines, including patients and healthcare professionals. So, how can industry help them to navigate this complexity?

Precision medicine represents a new paradigm in healthcare. It embodies the shift from treating many patients with the same therapy, to having the tools to identify the best treatment for every patient.

Spe­cial re­port: Twen­ty ex­tra­or­di­nary women in bio­phar­ma R&D who worked their way to the top

What differentiates a woman leader in biopharma R&D from a man?

Not much, except there are fewer of them in senior posts. Data suggest women are not more risk-averse, family-oriented or less confident than their male counterparts — indeed the differences between the two sexes are negligible. But a glance at the top R&D positions in Big Pharma leaves little doubt that upward migration in the executive ranks of biopharma R&D is tough.

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GSK's asth­ma bi­o­log­ic Nu­cala scores in rare blood dis­or­der study

GlaxoSmithKline’s asthma drug Nucala, which received a resounding FDA rejection for use in chronic obstructive pulmonary disease (COPD) last year, has shown promise in a rare blood disorder.

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Mer­ck buys a fledg­ling neu­rode­gen­er­a­tive biotech spawned by an old GSK dis­cov­ery al­liance. What’s up with that?

Avalon Ventures chief Jay Lichter has a well-known yen for drug development programs picked up in academia. And what he found in Haoxing Xu’s lab at the University of Michigan pricked his interest enough to launch one of his umbrella biotechs in San Diego.
Xu’s work laid the foundation for Avalon to launch Calporta, which has been working on finding small molecule agonists of TRPML1 (transient receptor potential cation channel, mucolipin subfamily, member 1) for lysosomal storage disorders. And that pathway, they believe, points to new approaches on major market neurodegenerative diseases like Parkinson’s, ALS and Alzheimer’s.

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FDA slaps a hold on an AML tri­al as Mark­er scraps a fail­ing ovar­i­an can­cer pro­gram, sink­ing shares

The FDA has placed a hold on a Phase II AML trial from the small immuno-oncology biotech Marker Therapeutics. Marker disclosed the issue two weeks after responding to FDA concerns, adding it to the Q3 release Tuesday. The company also announced it was scrapping a Phase II ovarian cancer program it determined was unlikely to succeed.

The agency’s concern centers around two reagents used in manufacturing for their trial for acute myeloid leukemia patients who have received a stem cell transplant. The reagents are from third parties and not present in the final product, Marker said.

Eli Lil­ly-backed biotech grabs $100M to dis­patch an­ti­body-oligonu­cleotide con­ju­gates af­ter mus­cu­lar dy­s­tro­phy

Hold up your hand. Make a fist. Now open it. And again.

If you can do it fully and with ease, then the proteins in your hand are likely working properly. If you can’t then they may not be. In people with myotonic muscular dystrophy, something more atomic is going on.

In those folks, the problem is RNA. Certain base pairs repeat far beyond normal, up to 11,000 superfluous letters in some cases. The extended strands form “clumps.” Proteins misform and can’t function properly. They often allow one movement but not the reverse, a condition called myotonia that gives the dystrophy its name.

As­traZeneca sets stage for mar­ket­ing ap­pli­ca­tion with promis­ing piv­otal lu­pus drug da­ta

After fumbling in its first late-stage lupus study, AstraZeneca disclosed that a second pivotal trial testing its experimental drug, anifrolumab, had met the main goal, in August. Earlier this week, the British drugmaker broke out the numbers from its successful study.

Last year, anifrolumab failed to meet the main goal of diminishing disease activity in the 460-patient TULIP I study, a 52-week trial that tested two doses of the drug versus a placebo. But in the 373-patient TULIP II study, the higher dose (300 mg) was compared to patients given a placebo — patients in both arms were on baseline standard care.

FDA Vas­cepa re­view spot­lights new safe­ty sig­nals, pos­si­ble min­er­al oil spoil­er as Amarin hunts a block­buster ap­proval

An in-house FDA review of Amarin’s Vascepa raises a set of hurdles the biotech will have to clear if the biotech expects to get the long-awaited FDA approval that could set it on a path to superstar status. But it appears that Amarin has survived another potential setback without introducing a major new threat to its prospects.

The stakes don’t get much higher, with analysts saying a win this week for Amarin could lead to billions in new sales — provided the agency stamps it with an OK. And investors liked what they say in the FDA review this morning, bumping the stock $AMRN 17%.

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FDA puts Sol­id Bio’s lead gene ther­a­py pro­gram on hold — again — af­ter an­oth­er pa­tient is hurt by SGT-001

Solid Biosciences continues to be plagued by safety issues.

Close to 18 months after the gene therapy biotech was able to quickly shed an FDA hold on their lead Duchenne muscular dystrophy program for SGT-001, regulators have stepped back in to force another halt after another patient was hit hard by a set of serious adverse events remarkably similar to the first set.

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