Fol­low­ing foot­steps of chart-top­ping Chi­nese coun­ter­parts, Al­pham­ab On­col­o­gy files IPO at HKEX

Less than two months af­ter rais­ing $60 mil­lion — its sec­ond ven­ture round in a decade — Al­pham­ab is mak­ing the hop for the pub­lic mar­kets.

In its IPO fil­ing with the Hong Kong stock ex­change, the Suzhou-based com­pa­ny de­scribes in more de­tail a game plan it sketched out in May: Beat down a di­rect path to mar­ket for its two lead bis­pecifics by run­ning mul­ti­ple par­al­lel clin­i­cal pro­grams, while prep­ping for the po­ten­tial com­mer­cial­iza­tion of its sub­cu­ta­neous PD-L1 and ad­vanc­ing an­oth­er CT­LA-4-based im­muno­sup­pres­sant.

Ting Xu Al­pham­ab

The HKEX might not have at­tract­ed near­ly as many biotech ap­pli­cants as the Nas­daq amid con­tin­ued con­cerns about tur­bu­lence, but it has de­liv­ered some hefty for­tunes for the few that made it. Of the top 10 bio­phar­ma IPOs from Jan­u­ary to June 2019, as com­piled by GEN, half are list­ed on the HKEX.

Han­soh, a phar­ma con­glom­er­ate that pulled its first fil­ing late last year to bring a few more VCs in­to the fold, topped the chart with $1 bil­lion in pro­ceeds.

Al­pham­ab is bet­ting that this buoy­ant tide will al­so float its boat. It had been prepar­ing for the IPO as soon as Hong Kong fi­nan­cial reg­u­la­tors green­light­ed rule amend­ments to al­low list­ings of pre-rev­enue biotechs, spin­ning out Al­pham­ab On­col­o­gy from the rest of the biotech pipeline.

With KN046, which tar­gets both PD-L1 and CT­LA-4, Al­pham­ab is look­ing at non-small cell lung can­cer, triple-neg­a­tive breast can­cer and esophageal squa­mous-cell car­ci­no­ma; KN026 is de­signed to treat HER2 ex­press­ing sol­id tu­mors by hit­ting two epi­topes of the re­cep­tor.

The plan al­so calls for the con­struc­tion of new man­u­fac­tur­ing and R&D sites in their home city.

Founder and CEO Ting Xu, who al­so chairs some of the oth­er sub­sidiaries un­der Suzhou Al­pham­ab, holds al­most half of the on­col­o­gy biotech via Rubymab. His close af­fil­i­ates, Xit­ian Zhang and Chuanx­i­ao Xue, are each in for around 10% while Ad­van­tech, PAG Growth and New Pavil­lion rep­re­sent the biggest in­sti­tu­tion­al back­ers at rough­ly 6% each.

So­cial im­age: Shut­ter­stock

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In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

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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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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.

Tony Coles, Cerevel CEO

Cerev­el takes the pub­lic of­fer­ing route, with a twist — rais­ing big mon­ey thanks to ri­val da­ta

As public biotechs seek to climb out of the bear market, a popular strategy to raise cash has been through public offerings on the heels of positive data. But one proposed raise Wednesday appeared to take advantage not of a company’s own data, but those from a competitor.

Cerevel Therapeutics plans to raise $250 million in a public offering and another $250 million in debt, the biotech announced Wednesday afternoon, even though it did not report any news on its pipeline. However, the move comes days after rival Karuna Therapeutics touted positive Phase III data in schizophrenia, a field where Cerevel is pursuing a similar program.

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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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Ab­bott pumps $450M+ in­to new Ire­land-based man­u­fac­tur­ing site project and hir­ing spree

As Ireland continues to see more investments and building projects from pharma companies, another contender is looking to place more investment in the Emerald Isle.

According to a report from The Irish Times on Friday, Abbott Laboratories is investing €440 million, or about $451 million, to build a new manufacturing plant in Kilkenny, located in the country’s southeast, to make more of its glucose monitors.

Tony Coles, Cerevel CEO

Cerev­el's Tony Coles is still count­ing his mon­ey as a ri­val's boost helps fu­el a po­ten­tial $609M wind­fall

These days in biotech, you never want to miss a chance to raise money for public companies. As much money as possible.

That survival strategy was in full view over the last 24 hours as Cerevel $CERE announced a major stock/debt raise, then upped the ante with a bigger debt load than initially planned.

The tally: $238 million – net — with a shot at boosting that to $274 million from the stock sale, provided the underwriters come back for more. And there’s $335 million from the debt, provided their first round buyers come back for an added bite. Rounding up, that’s $609 million with the add-on. Even without the add-ons, though, it’s still $530 million in the bank.

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Benjamin Oakes, Scribe Therapeutics CEO

CEO of Doud­na spin­out: With­in five years, genome ed­i­tors will have a 're­al­ly big im­pact' on pa­tients' lives

“CRISPR-by-design” is the idea behind Scribe Therapeutics, a company spun out from Jennifer Doudna’s Nobel-winning lab that’s competing in a closely-tracked field of genome editor companies just starting to make their way to the clinic.

After nabbing $100 million last March for its Series B funding round, Scribe is taking a different tack from some of its competitors, crafting a new enzyme isolated from bacteria called CasX, which has now been tweaked extensively and may be targeted to a range of genome-related diseases, offering a plethora of therapeutic options.

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