Can­cer drugs among US goods spared from tar­iffs as Chi­na is­sues first ex­emp­tions in trade war

In its first move to spare cer­tain US im­ports from the trade war, Chi­na has of­fered some re­lief to can­cer drug­mak­ers.

Twelve drugs — most­ly chemother­a­py agents — fea­tured on the list of prod­ucts to be ex­empt­ed from re­tal­ia­to­ry tar­iffs un­til Sep­tem­ber 2020. They al­so be­long to the sub­group where tar­iffs al­ready col­lect­ed will be re­turned.

As­traZeneca’s EGFR in­hibitor Ires­sa ap­pears to be the on­ly non-chemo drug in the group. Here’s the list, trans­lat­ed from the Min­istry of Fi­nance’s orig­i­nal an­nounce­ment:

decitabine, flox­uri­dine, cy­clophos­phamide, gefi­tinib, capecitabine, raltitrexed, flu­dara­bine, tega­fur, cy­tara­bine hy­drochlo­ride, gem­c­itabine hy­drochlo­ride, ico­tinib hy­drochlo­ride, ifos­famide

Of­fi­cials told the state-owned Peo­ple Dai­ly that there were three main rea­sons be­hind the ex­emp­tions on these 16 class­es of prod­ucts — in­clud­ing fish feed and lu­bri­cants — which marks the first time the Chi­nese gov­ern­ment has done so since the trade war start­ed. It’s been dif­fi­cult to find al­ter­nate sources for these goods, and tar­iffs have been detri­men­tal to both in­di­vid­ual com­pa­nies and the re­lat­ed in­dus­tries.

Leon Wang As­traZeneca

While the ex­emp­tions sig­nal good­will from Bei­jing, it’s un­like­ly to have a big im­pact on phar­ma play­ers’ plans in the coun­try as they shift their fo­cus from old drugs near the end of their patent life to in­no­v­a­tive treat­ments, which are get­ting to mar­ket more quick­ly thanks to dra­mat­ic re­forms. Last Au­gust, the reg­u­la­to­ry body, now known as the Na­tion­al Med­ical Prod­ucts Ad­min­is­tra­tion, un­veiled a list of 48 for­eign drugs el­i­gi­ble for pri­or­i­ty re­view.

Days ago, As­traZeneca’s head of in­ter­na­tion­al mar­kets Leon Wang said in an in­ter­view with Bloomberg that he ex­pects nov­el ther­a­pies to make up 60% of the com­pa­ny’s Chi­na rev­enue by 2024. The fig­ure was 18% in 2018 by Bloomberg’s count. Mean­while, No­var­tis has a plan to sub­mit 50 new drug ap­provals by 2023.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Alaa Halawaa, executive director at Mubadala’s US venture group

The ven­ture crew at Mubadala are up­ping their biotech cre­ation game, tak­ing care­ful aim at a new fron­tier in drug de­vel­op­ment

It started with a cup of coffee and a slow burning desire to go early and long in the biotech creation business.

Wrapping up a 15-year discovery stint at Genentech back in the summer of 2021, Rami Hannoush was treated to a caffeine-fueled review of the latest work UCSF’s Jim Wells had been doing on protein degradation — one of the hottest fields in drug development.

“Jim and I have known each other for the past 15 years through Genentech collaborations. We met over coffee, and he was telling me about this concept of the company that he was thinking of,” says Hannoush. “And I got immediately intrigued by it because I knew that this could open up a big space in terms of adding a new modality in drug discovery that is desperately needed in pharma.”

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'Band­ing to­geth­er': 50 fe­male biotech ex­ec­u­tives lay out plans for board di­ver­si­ty, new com­pa­nies and men­tor­ing founders

Earlier this month, during the Silicon Valley Bank meltdown, Angie You recalled the speed with which female biotech CEOs were helping each other connect with bankers, get their wires through and assuage concerns during a financial implosion.

This past weekend, 50 of about 125 women who are part of that Slack group and a broader coalition self-dubbed the Biotech Sisterhood met in person in Cancun for the second rendition of an annual summit connecting female biotech CEOs. The attendance list doubled that of the inaugural gathering in Arizona 12 months ago.

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Rohan Palekar, 89bio CEO

89bio’s PhII da­ta add to quick suc­ces­sion of NASH read­outs as field seeks turn­around

89bio said its drug was better than placebo at lessening fibrosis without worsening nonalcoholic steatohepatitis, or NASH, in two of three dose groups.

The San Francisco biotech said it thinks the Phase IIb data pave the way for a potential Phase III, following in the footsteps of another biotech in its drug class, Akero Therapeutics. To fund a late-stage study, CEO Rohan Palekar told Endpoints News 89bio “would need to raise additional capital,” with the company having about $188 million at the end of last year.

Flare Therapeutics biochemists Yong Li (L) and Valerie Vivat

A $123M Flare will get Third Rock on­col­o­gy biotech in­to the clin­ic this year

Flare Therapeutics will start its first human trial this year with an investigational urothelial cancer drug after pulling together a $123 million Series B from Big Pharmas, VCs and its incubator, Third Rock Ventures.

Launched in 2021 on the idea that a biotech could finally succeed at drugging the much-sought-after but stubborn transcription factor, Flare Therapeutics said Wednesday it is now primed for the clinic after closing its large financing haul earlier this year. The raise is a relatively stark figure in a tough startup financing environment but further buoys the upbeat signals coming out of other Third Rock biotechs in recent weeks, including the $200 million CARGO Therapeutics and $100 million Rapport Therapeutics rounds.

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Francesco Marincola, newly-appointed Sonata Therapeutics CSO

Kite's head of re­search leaves for Flag­ship start­up Sonata

Another leader is departing Kite Pharma, and will to spend the “last part” of his career exploring how cancer evades the immune system.

Kite’s senior VP and global head of cell therapy research Francesco Marincola left the Gilead CAR-T unit last week for Sonata Therapeutics. Flagship last May unveiled the startup, which was pieced together from two fledgling biotechs Inzen and Cygnal Therapeutics. As CSO, Marincola will lead Sonata’s push to reprogram cancer cells to make them more immunogenic.

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FDA in­di­cates will­ing­ness to ap­prove Bio­gen ALS drug de­spite failed PhI­II study

Ahead of Wednesday’s advisory committee hearing to discuss Biogen’s ALS drug tofersen, the FDA appeared open to approving the drug, newly released briefing documents show.

Citing the need for flexibility in a devastating disease like ALS, regulators signaled a willingness to consider greenlighting tofersen based on its effect on a certain protein associated with ALS despite a failed pivotal trial. The documents come after regulatory flexibility was part of the same rationale the agency expressed when approving an ALS drug last September from Amylyx Pharmaceuticals, indicating the FDA’s openness to approving new treatments for the disease.

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Roche and Lil­ly team up to de­vel­op blood test to de­tect ear­ly signs of Alzheimer's

Eli Lilly is teaming up with Roche to help develop a blood test to detect early signs of Alzheimer’s disease and determine whether a patient should go for further confirmatory testing.

Roche’s Elecsys Amyloid Plasma Panel (EAPP) measures pTau 181 protein assay and APOE E4 assay in human blood plasma – elevations in pTau 181 are present in the early stages of Alzheimer’s, while the presence of APO E4 is the most common genetic risk factor for the disease.

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NIH re­jects an­oth­er at­tempt to 'march-in' on Astel­las' prostate can­cer drug over ex­ces­sive price

The National Institutes of Health has again declined to use so-called “march-in” rights to lower the price of Astellas and Pfizer’s prostate cancer drug Xtandi despite being invented at UCLA with grants from the US Army and NIH.

“Given the remaining patent life and the lengthy administrative process involved for a march-in proceeding, NIH does not believe that use of the march-in authority would be an effective means of lowering the price of the drug,” NIH told prostate cancer patients Robert Sachs and Clare Love, in a letter shared with Endpoints News. The institutes’ analyses found Xtandi “to be widely available to the public,” an indication that there was not a pressing need for the US to act.