Tasly Bio­phar­ma pitch­es long-await­ed IPO — will it trig­ger an­oth­er $1B gold rush on HKEX?

In the run up to the Hong Kong stock ex­change’s an­tic­i­pat­ed rule change — open­ing the door for Chi­nese pre-rev­enue biotechs to go pub­lic clos­er to home — more than a year ago, Tasly Bio­phar­ma was one of the big play­ers whose ru­mored in­ter­est helped stoke en­thu­si­asm for the new list­ing venue. The com­pa­ny has since kept the drum­roll rum­bling in the back­ground, rais­ing a pre-IPO round and con­vinc­ing part­ner Trans­gene to swap own­er­ship in a joint ven­ture for eq­ui­ty. Now the oth­er shoe has fi­nal­ly dropped as ex­ecs out­line plans for a pipeline dom­i­nat­ed by car­dio­vas­cu­lar drugs.

Kai­jing Yan Tasly

As is stan­dard prac­tice, Tasly did not pin a fig­ure on their pitch, though pre­vi­ous re­ports have sug­gest­ed goals around $1 bil­lion — the amount that Han­soh Phar­ma, an­oth­er do­mes­tic pow­er­house, has fetched in its re­cent IPO.

For­mer­ly known as Shang­hai Tasly, the com­pa­ny was launched in 2001 when its par­ent de­cid­ed to lever­age its well-known Chi­nese med­i­cine brand and en­trenched mar­ket po­si­tion for a piv­ot to the mod­ern phar­ma busi­ness.

And un­like some of its biotech peers on the HKEX, Tasly is a rev­enue-book­ing op­er­a­tion. Thanks to a re­com­bi­nant hu­man ki­nase prod­uct — dubbed pro-UK, ap­proved in 2011 for blood-clot in­duced heart at­tacks — it made around $35 mil­lion (RMB 240 mil­lion) last year.

Tasly clear­ly sees po­ten­tial in the mar­ket. In ad­di­tion to en­vi­sion­ing pro-UK as a block­buster throm­bolyt­ic drug in Chi­na, it’s al­so lined up two more drugs with the same mech­a­nism of ac­tion as its late-stage fa­vorites. B1140, in Phase III, is de­signed to treat acute is­chemic stroke; B1448, mean­while, is un­der Phase II test­ing for acute pul­monary em­bolism.

But Tasly’s team of 96 re­searchers are not lim­it­ing them­selves to the car­dio space.

On­col­o­gy/au­toim­mune and al­i­men­ta­ry tract/me­tab­o­lism rep­re­sent the two oth­er big ar­eas it would like to fo­cus on. And in the IPO fil­ing Tasly high­light­ed SY101, an EGFR-tar­get­ed drug, which they are po­si­tion­ing for col­orec­tal can­cer. Er­bitux and Avastin are the on­ly bi­o­log­ics on the mar­ket for this in­di­ca­tion, they point out, and their Phase I drug ap­pears com­pet­i­tive on both ef­fi­ca­cy and safe­ty fronts.

The rest of the pipeline casts a wide net, with tar­gets rang­ing from he­pati­tis B and type 2 di­a­betes to NASH and non-Hodgkin lym­phoma. Some of these projects, in­clud­ing SY101, are de­vel­oped at Tasly’s Shang­hai Saiyuan and Trans­gene Tasly sub­sidiaries.

Kai­jing Yan, the son of Tasly founder Xi­jun Yan, has large­ly tak­en over the fam­i­ly busi­ness, which con­trols the biotech com­pa­ny via a 90%-plus stake. Trans­gene, Pudong Sci­ence and Tech­nol­o­gy and promi­nent VC group Al­ly Bridge each claims a sin­gle-dig­it per­cent­age of shares.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 64,800+ biopharma pros reading Endpoints daily — and it's free.

The lat­est Cin­derel­la sto­ry in on­col­o­gy ends with a sud­den rout as up­dat­ed da­ta dis­play spooks in­vestors

NextCure’s turn as the Cinderella of cancer-focused biotechs was short-lived.
Just a few days after its shares $NXTC zoomed up more than 250% on some very early stage results in a SITC abstract, a more complete analysis over the weekend spiked the hype and left investors in high dudgeon as the stock price collapsed back towards earth Monday.
The focus at NextCure is centered on NC318, an antibody that is intended to shut down the immunosuppressive Siglec-15 — or S-15 — target. After adding a small group of patients to the readout, investigators circled 2 clinical responses, a complete and partial response, along with 4 stable disease cases in non-small cell lung cancer.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 64,800+ biopharma pros reading Endpoints daily — and it's free.

Te­va spin­out rais­es $85M in IPO; No­var­tis beefs up gener­ics unit with $440M deal

→ After Teva spinout 89bio recently announced that its IPO was being held up, the company is back in the game offering 5,304,687 shares at a price of $16 per share. The company has raised $84.9 million IPO in gross proceeds and will be listed under the ticker symbol $ETNB. BofA Securities, SVB Leerink and RBC Capital Markets are the joint book-running managers for the offering. Oppenheimer & Co is the co-manager for the offering.
→ Looking to amp up its presence in Japan’s hospitals, Novartis has struck a deal to buy out Aspen’s portfolio of generics in the world’s third largest healthcare market. The pharma giant is paying $440 million for Aspen’s Japanese subsidiary.
→ Novartis said tropifexor, a non-bile acid FXR agonist, has scored on several key biomarkers of NASH in a Phase IIb trial, including reductions in hepatic fat, alanine aminotransferase and body weight compared to a placebo at 12 weeks.

Break­through sta­tus and promise of a speedy re­view ar­rives for Op­di­vo/Yer­voy com­bi­na­tion as Bris­tol-My­ers bites at Bay­er

Its frontline and single-agent aspirations have been set back, but Bristol-Myers Squibb just took a big step forward in its efforts to apply its checkpoint inhibitor Opdivo to liver cancer. The FDA has granted breakthrough status and priority review to a combination, second-line treatment.

The designation is for Opdivo (nivolumab) in combination with Yervoy (ipilimumab),  for treating advanced hepatocellular carcinoma (HCC), the most common form of liver cancer. The PD-L1 drug was already approved as a single-agent, second-line treatment for HCC. A PDUFA date was set for March 10, 2020 — just 4 months from now.

Third time un­lucky: Lipocine's lat­est quest to mar­ket their oral testos­terone drug snubbed again by FDA

Lipocine’s latest attempt at securing approval for its oral testosterone drug has fizzled yet again.

The Utah-based drug developer on Monday said the FDA has spurned its marketing application, indicating that some efficacy data on the drug, Tlando, was not up to scratch to treat male hypogonadism, a condition characterized by low production of the hormone testosterone, which is responsible for maintaining muscle bulk, bone growth, and sexual function.

UP­DAT­ED: De­cry­ing 'ar­bi­trary and capri­cious' ac­tion, Re­genxBio sues FDA over clin­i­cal holds on gene ther­a­py

When RegenxBio disclosed that the FDA had placed a partial clinical hold on one of its lead gene therapies, execs outlined several customary next steps: continuing assessment and monitoring, delaying a related IND filing, and working with the FDA to address the matter.

As it turned out, they were planning something much less mundane. Two days after announcing the hold in its Q3 update, RegenxBio filed a lawsuit seeking to set it aside, the FDA Law Blog noted.

Roche's SMA chal­lenge to Bio­gen's Spin­raza fran­chise looms larg­er with piv­otal win

Roche has just landed a crucial advance in scoring a come-from-behind win on the spinal muscular atrophy field, giving Novartis and Biogen a run for their money.

The update was brief, but Roche said risdiplam hit the primary endpoint in the placebo-controlled pivotal SUNFISH trial, meeting the threshold for change from baseline in the Motor Function Measure 32 (MFM-32) scale after one year of treatment. The results, which is the second, confirmatory portion of a two-part study, involved 180 patients with type 2 or 3 spinal muscular atrophy between 2 and 25 years old.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 64,800+ biopharma pros reading Endpoints daily — and it's free.

Roche steers Gazy­va in­to a new PhI­II pro­gram af­ter com­bo shows promise in lu­pus nephri­tis study

Roche is working on putting together a late-stage study for its monoclonal antibody Gazyva in patients with severe kidney disease associated with lupus after a combination approach helped patients in a mid-stage study.

The 125-patient NOBILITY trial evaluated Gazyva, combined with standard-of-care treatment mycophenolate mofetil or mycophenolic acid and corticosteroids, versus standard treatment alone. The combo met the main goal of inducing a statistically superior complete renal response (CRR) of 40% at week 76, versus 18% in patients given standard treatment, Roche said.