Gaxin Xia

Shang­hai biotech tack­ling kid­ney dis­ease gets an­oth­er round of cash

Four months af­ter a se­cre­tive Shang­hai biotech pulled in $60 mil­lion for a Se­ries B round, it’s re­turn­ing to the fore with a lit­tle more cash.

Ale­bund Phar­ma­ceu­ti­cals closed a $54.5 mil­lion round it’s de­scrib­ing as “Se­ries B+,” the com­pa­ny an­nounced Mon­day evening, aim­ing to fur­ther ad­vance its kid­ney dis­ease pro­grams. Funds will go to­ward two clin­i­cal as­sets as well as the con­struc­tion of a man­u­fac­tur­ing site, Ale­bund said in a re­lease.

“The B+ fi­nanc­ing round once again shows glob­al in­vestors’ strong be­lief in Ale­bund’s ca­pa­bil­i­ties to de­vel­op nov­el kid­ney dis­ease drugs,” CEO Gavin Xia said in a state­ment. “We are very grate­ful to the new and ex­ist­ing in­vestors who sup­port us to main­tain our lead­ing po­si­tion in re­nal ther­a­py in­no­va­tion and to pro­vide glob­al re­nal pa­tients with safe and ef­fec­tive ther­a­pies soon.”

The new round was led by 3H Health In­vest­ment, Loy­al Val­ley Cap­i­tal and Morn­ing­side Ven­tures, fol­lowed by Yuan­Bio Ven­ture Cap­i­tal, Oc­ta­gon Cap­i­tal, Veri­tion Fund Man­age­ment and HT Cap­i­tal. Old­er in­vestors in­clud­ing Lil­ly Asia Ven­tures, Quan Cap­i­tal, 3E Bioven­tures Cap­i­tal and Sher­pa Health­care Part­ners al­so par­tic­i­pat­ed.

End­points News has reached out to the com­pa­ny for com­ment.

Jin Tian

Much like with the Se­ries B an­nounce­ment, few de­tails emerged about the biotech in its an­nounce­ment, but it boast­ed of be­ing the first Chi­nese phar­ma­ceu­ti­cal com­pa­ny sole­ly fo­cus­ing on kid­ney dis­ease. Both of Ale­bund’s two clin­i­cal pro­grams are seek­ing to treat hy­per­phos­phatemia among the broad­er chron­ic kid­ney dis­ease pop­u­la­tion, with one in Phase II de­vel­op­ment.

That lead pro­gram is at­tempt­ing to treat the dis­ease with an old pro­gram orig­i­nal­ly de­vel­oped by the small South Dako­ta-based biotech Vi­dasym, ac­cord­ing to the clin­i­cal­tri­ reg­istry. Per a 2016 pa­per in the British Jour­nal of Phar­ma­col­o­gy, the pro­gram is de­rived from aca­cia tree sap and de­signed to bind to phos­phate in the blood with min­i­mal side ef­fects.

Jin Tian, who is a clin­i­cal con­sul­tant at Vi­dasym, is al­so co-founder and CMO of Ale­bund. Ale­bund hopes to launch a piv­otal Phase III study next year.

The CKD field in Chi­na has not made as many ad­vances in re­cent years as on­col­o­gy, and Ale­bund is os­ten­si­bly work­ing to fill that gap. Fi­bro­Gen did score an ap­proval for its ane­mia drug rox­adu­s­tat in Chi­na back in 2018 and in the EU last month, but the FDA re­ject­ed the com­pa­ny’s pitch to sell it in the US just a month ago.

Clar­i­fi­ca­tion: This ar­ti­cle has been up­dat­ed to clar­i­fy Jin Tian’s role at Vi­dasym. He is a clin­i­cal con­sul­tant, not the leader of clin­i­cal stud­ies. 

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His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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No­var­tis re­ports two pa­tient deaths af­ter treat­ment with Zol­gens­ma

Two children with spinal muscular atrophy have died after receiving Novartis’ Zolgensma, a gene therapy designed as a one-time treatment for the rare fatal disease.

The deaths, which resulted from acute liver failure, occurred in Russia and Kazakhstan, Novartis confirmed in a statement to Endpoints News. Having notified health authorities across all the markets where Zolgensma is available, it will update the drug label “to specify that fatal acute liver failure has been reported,” a spokesperson wrote.

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House pass­es his­toric drug pric­ing re­forms, lin­ing up decades-in-the-mak­ing win for Biden and De­moc­rats

The US House of Representatives today voted along party lines (all Dems voted for it), 220-207 to pass new, wide-ranging legislation that will allow Medicare drug price negotiations for the first time ever, and cap seniors’ drug expenses to $2,000 per year and seniors’ insulin costs at $35 per month.

Setting up a major victory for President Joe Biden, representatives returned from their summer recess to pass the Inflation Reduction Act, even as many noted the bill would only modestly reduce inflation.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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