FiercePharmaAsia—Astellas' $3B gene therapy bet; China's PD-1 coverage; Hanmi-Rapt I-O deal

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Astellas, the China reimbursement drug list, Hanmi and Brii made our news this week. (Google)

Due to the Thanksgiving holiday, we're bringing you two weeks of biopharma movement in this issue. Astellas is marching into gene therapy with a $3 billion buyout of Audentes Therapeutics. Only one PD-1 inhibitor won coverage in China after the latest round of price negotiations—and the price cut is alarming for Keytruda and Opdivo. Hanmi Pharma has grabbed South Korea and greater China rights to Rapt Therapeutics’ lead cancer program for potentially $118 million. And more.

1. Astellas inks $3B Audentes buyout to expand in gene therapy

Astellas is betting $3 billion on gene therapy via an acquisition of Audentes Therapeutics. The target biotech’s lead candidate, X-linked myotubular myopathy gene therapy AT132, is set for regulatory filings in the U.S. and Europe next year. The question marks over the commercial potential of AT132 didn’t stop the Japanese pharma from paying a whopping 110% premium for the biotech.

2. China gives Merck, BMS cold shoulder on reimbursement list as PD-1 battle enters new phase

Drugmakers cut prices by an average 60.7% in the latest round for China’s National Reimbursement Drug List. In the closely watched PD-1 realm, neither Merck & Co.’s Keytruda nor Bristol-Myers Squibb’s Opdivo won coverage. Tyvyt, co-developed by domestic firm Innovent Biologics and Eli Lilly, was the only PD-1 added to the list, after agreeing to a price cut of 64% for the small indication of classical Hodgkin lymphoma.

3. Rapt edges into Asia with Hanmi I-O deal worth up to $118M

Hanmi Pharmaceutical is gaining South Korea and greater China rights to Rapt Therapeutics’ lead cancer program, a CCR4 antagonist dubbed FLX475. In addition to the $10 million upfront fee, Hanmi has committed altogether $108 million tied to potential development and commercial milestones in exchange for a “keystone” in its immuno-oncology portfolio.

4. Brii Biosciences nabs Icon, GSK veteran to lead new focus on neuroscience

Brii Biosciences, which up until now has focused on antibiotics and anti-infectives, is pushing into new therapeutic territory. It has tapped John Kraus, M.D., Ph.D., a veteran of Icon and GlaxoSmithKline, to lead its neuroscience efforts. The company, a bridge biotech between China and the U.S., says central nervous system disorders pose a big opportunity in China mainland as its population ages.

5. Takeda eyes Alunbrig earlier lung cancer use as 2-year data trounce Pfizer’s Xalkori

After 25 months of treatment, Takeda’s Alunbrig cut the risk of disease progression by 51% compared with Pfizer’s Xalkori in ALK inhibitor-naïve non-small cell lung cancer, as assessed by an independent review committee. The company plans to use the data for approvals to follow Novartis’ Zykadia and Roche’s Alecensa into front-line use.

6. SK Biopharmaceuticals, fresh off an FDA nod, preps for $850M IPO in January: report

SK Life Science plots 2020 launch for now-approved seizure drug Xcopri

South Korea’s SK Biopharmaceuticals is planning a January IPO to raise about $850 million, the Financial Times reported. The news came on the heels of an FDA approval for the company’s Xcopri to treat partial-onset seizures in adults. The firm’s U.S. subsidiary is planning to launch the med next year with 100 to 125 sales reps.

7. Takeda's dengue vaccine efficacy slips between 12- and 18-month analyses

In a new 18-month data analysis from a massive study of Takeda’s dengue vaccine candidate TAK-003, the shot was 73.3% effective overall, down from 80% at the 12-month point. Results from dengue serotype 3 raised concerns, as the shot was only 49% effective in that group at 18 months, a result Takeda said was “statistically inconclusive but suggests a lack of efficacy.”

8. HLB defends itself in row over 'Best of ESMO 2019' claim

A statement from HLB saying its rivoceranib’s phase 3 Angel study was “selected” by the European Society for Medical Oncology congress as “The Best of ESMO 2019” shot up the company’s stock but also caused controversy. A spokesperson for ESMO, responding to questions from Bloomberg, said there was no “Best of ESMO 2019” award.

And a few more:

Japan's Kyowa Kirin reorganizes quality responsibilities 

Tokyo's Heartseed reaps $26M to test its stem cell injections for heart failure

Biocon gets FDA approval to produce pegfilgrastim in India