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.

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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Ed­i­tas and Cel­gene sub Juno are tack­ling hottest im­munother­a­py cells

As the first CRISPR-edited cancer patients watch their treatments unfold, one of the first CRISPR companies is rejigging a major oncology deal.

Editas Medicine is amending its long-running collaboration with Celgene and their subsidiary Juno Therapeutics. The new deal will expand the focus of their work to cover a subset of immune cells that have become an increasingly hot target for immunotherapy: gamma-delta cells.

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%.
The insider take at the agency includes a note on two new safety signals seen in the big cardio outcomes study of the omega-3 fatty acid drug that shocked many analysts with a solid set of efficacy data. There’s a key concern over whether the use of mineral oil in the placebo skewed LDL levels in such a way that tilted the data in Amarin’s favor.
The FDA overview was written by John Sharretts, the acting deputy director in the Division of Metabolism and Endocrinology Products. 
On the safety side, the internal review focused on a 3.1% versus 2.1% rate of adjudicated events of atrial fibrillation or atrial flutter requiring hospitalization. But they also say a-fib shouldn’t confound the benefit-safety of the drug — given the improvement on MACE — or prevent its use. And then there was also a higher rate of bleeding events in the drug arm.

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Prakash Raman. Flagship

Flag­ship woos No­var­tis top deal­mak­er Prakash Ra­man in move to get the BD ball rolling ear­ly

Flagship Pioneering likes to be ahead of its times — so far ahead, perhaps, that it is often challenging to find partners for their startups while the scientific scaffolding is underway. But Prakash Raman is here to change that.

Raman, who most recently headed up business development at the Novartis Institutes for BioMedical Research, became Flagship’s first chief business development officer two weeks ago. By acting as a “central resource” for the 100 companies in the venture fund’s portfolio, he hopes to help entrepreneurs and management teams strategize about dealmaking to capture value beyond the near-term validation of their platform technologies, Raman told Endpoints News.

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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Bill Haney, Skyhawk

Cel­gene ex­ecs shell out $92M cash for a pair of R&D deals that will fit per­fect­ly in their new home at Bris­tol-My­ers

With Bristol-Myers Squibb’s Celgene buyout all but complete, the BD teams are working in perfect synchrony now. The Celgene side is going back to Skyhawk, a darling of the crowd that set out to drug RNA, and they’re adding a suite of new programs that mesh perfectly with the new regime in charge.

Celgene is shelling out $80 million in a cash upfront to add oncology, immuno-oncology and autoimmune diseases to the initial roundup of neurological targets mapped early in Skyhawk’s existence.

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Reata's bar­dox­olone of­fers promise in pa­tients with rare kid­ney dis­or­der

After surprising Wall Street with positive data on its drug, omaveloxolone, in patients suffering from a notoriously hard-to-treat degenerative neuromuscular disorder last month, Reata Pharma on Monday unveiled pivotal results from a trial testing another drug, bardoxolone, in patients with a rare, genetic form of chronic kidney disease for which there exist no approved therapies.

Bardoxolone, like Reata’s other lead drug — omaveloxolone — is a small molecule engineered to bind to a gene called Keap1 to enhance the activity of the protein Nrf2 in order to defuse inflammation.

Am­gen ax­es 149 of its staff in Cam­bridge of­fice; Evotec, Mil­li­pore­Sig­ma en­ter re­search pact

→ Amgen has submitted a Worker Adjustment and Retraining Act (WARN) — a warning of impending mass layoffs 60 days in advance of the date — to the state of Massachusetts in the wake of the company’s exodus from the neurosciences R&D sector. David Reese, the company’s R&D chief, said at the time that the company is cutting ties in the field to focus on other undisclosed areas. In its WARN notice, the Cambridge-based company stated that 149 of its employees would be affected — among the total 180 being let go. The terminations will take effect on December 31, 2019.