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.

Susan Galbraith, AstraZeneca EVP, oncology R&D, at EUBIO22 (Rachel Kiki for Endpoints News)

Up­dat­ed: As­traZeneca jumps deep­er in­to cell ther­a­py 2.0 space with $320M biotech M&A

Right from the start, the execs at Neogene had some lofty goals in mind when they decided to try their hand at a cell therapy that could tackle solid tumors.

Its founders have helped hone a new approach that would pack in multiple neoantigen targets to create a personalized TCR treatment that would not just make the leap from blood to solid tumors, but do it with durability. And they managed to make their way rapidly to the clinic, unveiling their first Phase I program for advanced tumors just last May.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi and DN­Di aim to elim­i­nate sleep­ing sick­ness in Africa with promis­ing Ph II/III re­sults for new drug

The Drugs for Neglected Diseases initiative (DNDi) and Sanofi today said that their potential sleeping sickness treatment saw success rates of up to 95% from a Phase II/III study investigating the safety and efficacy of single-dose acoziborole.

The potentially transformative treatment for sleeping sickness would mainly be targeted at African countries, according to data published today in The Lancet Infectious Diseases medical journal. The clinical trial was led by DNDi and its partners in the Democratic Republic of the Congo (DRC) and Guinea, with the authors noting:

Lil­ly's Covid-19 mAb no longer au­tho­rized due to Omi­cron sub­vari­ants, FDA says

The FDA on Wednesday announced that Eli Lilly’s Covid-19 drug bebtelovimab is no longer authorized to treat Covid-19 because of the rising numbers of two new subvariants that the drug does not work against.

The Centers for Disease Control and Prevention last week published new estimates that the combined proportion of Covid-19 cases caused by the Omicron subvariants BQ.1 and BQ.1.1 are greater than 57% nationally, and already above 50% in all individual regions but one.

Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

Pharma advertisers on Twitter are done — at least for now. Ad spending among the previous top spenders flattened even further last week, according to the latest data from ad tracker Pathmatics, amid ongoing turmoil after billionaire boss Elon Musk’s takeover now one month ago.

Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Vi­a­tris with­draws ac­cel­er­at­ed ap­proval for top­i­cal an­timi­cro­bial 24 years lat­er

After 24 years without confirming clinical benefit, the FDA announced Tuesday morning that Viatris (formed via Mylan and Pfizer’s Upjohn) has decided to withdraw a topical antimicrobial agent, Sulfamylon (mafenide acetate), after the company said conducting a confirmatory study was not feasible.

Sulfamylon first won FDA’s accelerated nod in 1998 as a topical burn treatment, with the FDA noting that last December, Mylan told the agency that it wasn’t running the trial.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 153,800+ biopharma pros reading Endpoints daily — and it's free.

Emily Leproust, Twist Bioscience CEO

Twist Bio­science’s 'fac­to­ry of the fu­ture' in Ore­gon could de­liv­er with com­pet­i­tive pric­ing, SVB Se­cu­ri­ties says

The synthetic DNA manufacturer Twist Bioscience has given a peek behind the curtain to several analysts into its “factory of the future” as well as insight into the cost structure, workflow and technology at the site.

The 110,000-square-foot manufacturing site in the city of Wilsonville, OR, just south of Portland, which was announced back in 2020, will double Twist’s production capacity and bring around 400 jobs to the area.

Digital render of CPI's Medicines Manufacturing Innovation Centre in Glasgow, Scotland (Image: uk-cpi.com)

CPI opens the doors to a new $100M+ man­u­fac­tur­ing fa­cil­i­ty in Scot­land

A manufacturing site that has received interest and investments from large pharma companies and the UK government is opening its doors in Scotland.

The manufacturer CPI (Centre for Process Innovation) has opened a new £88 million ($105 million) “Medicines Manufacturing Innovation Centre” in Glasgow, Scotland, to accelerate the development of manufacturing tech and solve longstanding challenges in medicine development and manufacturing.

Lex­i­con slams FDA over hear­ing de­nial fol­low­ing a CRL for its SGLT2 in­hibitor can­di­date

Lexicon Pharmaceutical is not giving up on its Type I diabetes candidate, despite FDA’s repeated rejections. This week the company laid out is argument again for a hearing on sotagliflozin in response to the FDA’s most recent denial.

The issue goes back to March 2019 when the FDA made very clear to Lexicon and its now departed partner Sanofi that it would not approve their application for a potential Type I diabetes drug because it does not appear to be safe.