Chi­nese reg­u­la­tors on Fri­day signed off on the sec­ond ap­proval for Hutchmed’s on­col­o­gy drug su­r­u­fa­tinib af­ter a suc­cess­ful Phase III tri­al.

Known com­mer­cial­ly as Su­lan­da in Chi­na, the drug re­cent­ly ap­proved for ad­vanced pan­cre­at­ic neu­roen­docrine tu­mors al­so won ap­proval in Chi­na 7 months ago for the treat­ment of non-pan­cre­at­ic neu­roen­docrine tu­mors.

Hutchmed CEO Chris­t­ian Hogg said in a state­ment, “Since its launch in Jan­u­ary this year, pa­tients with ep­NETs have ben­e­fit­ed from treat­ment with su­r­u­fa­tinib through its unique mode of ac­tion by both in­hibit­ing an­gio­gen­e­sis and pro­mot­ing the body’s im­mune re­sponse against tu­mor cells.”

Hutchmed re­cent­ly filed for a $603 mil­lion IPO in Hong Kong, which will serve as a home­com­ing for the com­pa­ny as it has been list­ed on the Nas­daq since 2016. The com­pa­ny is cur­rent­ly await­ing FDA re­view of su­r­u­fa­tinib, which was filed in May. Hutchmed was the first Chi­nese com­pa­ny to bring an in-house on­col­o­gy drug to mar­ket in that coun­try with fruquin­tinib, which was ap­proved as a third-line ther­a­py for metasta­t­ic CRC. — Josh Sul­li­van

SCO­TUS de­nies Amarin’s last bid to save patent

The Supreme Court has shot down Amarin’s last bid to win back its patents on what would have been a block­buster heart drug.

The court de­nied the Irish drug­mak­er’s re­quest to re­view an ap­peal’s court de­ci­sion that found key patents over its fish oil-based drug were in­valid. That rul­ing, com­ing near­ly a year af­ter the com­pa­ny showed their omega-3 tablets could pre­vent heart at­tacks and strokes, had turned what could have been an in­stant block­buster in­to a mod­est com­mer­cial prod­uct that, in the US, would have to com­pete with gener­ic com­peti­tors.

The ap­peals court rul­ing up­held a low­er court de­ci­sion from March 2020 that found that, al­though ri­val drug­mak­ers would in­fringe on sev­er­al claims in Amarin’s patents by mar­ket­ing gener­ics, those claims were “ob­vi­ous” and in­valid. — Ja­son Mast

Chi­na gives third OK to BeiGene’s BTK in­hibitor

BeiGene is stack­ing up the Chi­nese ap­provals for Brukin­sa.

The Na­tion­al Med­ical Prod­ucts Ad­min­is­tra­tion has cleared the BTK in­hibitor for pa­tients with Walden­ström’s macroglob­u­line­mia who have re­ceived at least one pri­or ther­a­py, now the third B-cell ma­lig­nan­cy it’s ap­proved to treat.

The biotech tout­ed car­dio­vas­cu­lar safe­ty ad­van­tages on top of “deep and durable re­spons­es.” Even though it failed to beat J&J and Ab­b­Vie’s Im­bru­vi­ca on com­plete re­sponse rates in the head-to-head AS­PEN tri­al in­volv­ing 229 pa­tients, reg­u­la­tors de­cid­ed last Oc­to­ber that the low­er rate of side ef­fects (plus oth­er signs of ef­fi­ca­cy) were enough to war­rant a pri­or­i­ty re­view.

“Brukin­sa was specif­i­cal­ly de­signed by BeiGene sci­en­tists to lim­it off-tar­get ef­fects seen with first-gen­er­a­tion BTK in­hibitors and we have built a broad clin­i­cal de­vel­op­ment pro­gram to as­sess clin­i­cal ben­e­fit, in­clud­ing the head-to-head AS­PEN tri­al,” Jane Huang, BeiGene’s CMO in hema­tol­ogy, said in a state­ment.

Out­side of Chi­na, the FDA has ap­proved Brukin­sa for man­tle cell lym­phoma, while BeiGene is look­ing to carve out mar­ket share from Im­bru­vi­ca on oth­er fronts like re­lapsed/re­frac­to­ry CLL or small lym­pho­cyt­ic lym­phoma. — Am­ber Tong

Rafael Phar­ma­ceu­ti­cals gears for merg­er

A late-stage on­col­o­gy play­er is look­ing to back­flip on­to the New York Stock Ex­change, as Rafael Phar­ma­ceu­ti­cals makes plans to merge with Rafael Hold­ings $RFL.

The com­pa­nies shared the news of their im­pend­ing merg­er on Mon­day morn­ing. Rafael’s lead can­di­date de­vimi­s­tat, de­signed to tar­get can­cer meta­bol­ic path­ways, is cur­rent­ly in Phase III tri­als for metasta­t­ic pan­cre­at­ic can­cer and re­lapsed or re­frac­to­ry acute myeloid leukemia.

CEO Ameet Mallik, for­mer ex­ec­u­tive VP and head of No­var­tis’ US on­col­o­gy busi­ness, is ex­pect­ed to steer the com­pa­ny to Phase III read­outs in metasta­t­ic pan­cre­at­ic can­cer at the end of this year, ac­cord­ing to a state­ment. The drug has re­ceived fast-track des­ig­na­tion for that in­di­ca­tion, as well as AML.

“I am tru­ly ex­cit­ed to lead the Com­pa­ny at this piv­otal time as we ad­vance de­vimi­s­tat, a pipeline in a mol­e­cule, through two Phase 3 reg­is­tra­tional clin­i­cal tri­als and sev­er­al Phase 1 and Phase 2 clin­i­cal tri­al pro­grams in ad­di­tion­al in­di­ca­tions,” he said. — Nicole De­Feud­is

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

The EU is reportedly working toward a centralized procurement deal for smallpox vaccines to tackle the rising number of cases of monkeypox, according to sources who spoke to the Financial Times.

Andrea Ammon, director of Europe’s CDC, told the FT that the European Commission is “definitely looking at what can be done centrally” and central procurement is “one of the options that are looked at but of course countries are also” looking into bilateral avenues.

More than 500 stakeholders sent comments to the FTC on whether the commission should look further into pharma middlemen, known as PBMs, with many of the commenters calling for more federal oversight.

Similar to the critical open comment period in a deadlocked FTC session last February, pharmacies and pharmacy groups are continuing to call out the lack of transparency among the top 3 PBMs, which control about 80% of the market.