Zhi Hong, Brii Bio CEO (file photo)

Bap­tized by Covid-19 fire, Brii Bio reaps $320M Hong Kong IPO to car­ry on with pipeline for in­fec­tious dis­eases and be­yond

Zhi Hong start­ed Brii Bio three years ago with the clear vi­sion that his trans-Pa­cif­ic start­up should have the best of both worlds — top-notch in­no­va­tion from the US, vast pa­tient pool and mar­ket in Chi­na — teth­ered by his years of ex­pe­ri­ence work­ing at Glax­o­SmithK­line’s in­fec­tious dis­ease team.

Ankang Li

In a sense, the strat­e­gy was ex­em­pli­fied (even if slight­ly re­versed) as the biotech de­cid­ed to join the hunt for a Covid-19 an­ti­body ear­ly last year: Its drug, which was de­vel­oped to­geth­er with Chi­nese sci­en­tists based on mon­o­clon­al an­ti­bod­ies iso­lat­ed from re­cov­ered pa­tients in Chi­na, was se­lect­ed by the NIH for large-scale plat­form tri­als in the US.

But when it came to launch­ing an IPO, Brii Bio had to choose: US or Chi­na first?

The biotech ul­ti­mate­ly went with the Hong Kong ex­change, where it’s now raised $320 mil­lion to steer a di­verse slate of pro­grams through the clin­ic with a fo­cus on pub­lic health. A to­tal of 11 cor­ner­stone in­vestors backed the list­ing, which saw the com­pa­ny price at the top of its range.

“I think Hong Kong stock mar­ket has be­come one of the most ac­tive fundrais­ing mar­kets for biotech com­pa­nies in the past two years,” CFO Ankang Li told End­points News.

Be­sides, out­side of Covid-19, Brii’s most ad­vanced can­di­dates are the two he­pati­tis B pro­grams in-li­censed from Vir and VBI, which are be­ing test­ed as a com­bo in a Phase IIb tri­al. Asian in­vestors, the com­pa­ny be­lieves, are more fa­mil­iar with the Chi­nese mar­ket that it’s try­ing to tap.

“So for HBV mar­ket in gen­er­al, I think Chi­na is def­i­nite­ly the largest mar­ket glob­al­ly,” Li said. “We have more than 78 mil­lion pa­tients in­fect­ed by HBV. So this is a huge mar­ket, and the cur­rent stan­dard of care, which in­cludes an­tivi­ral and in­ter­fer­on, they are not re­al­ly sat­is­fy­ing treat­ments be­cause they de­liv­er very low cure rate, be­low 7%.”

Even with big­ger play­ers like Roche pur­su­ing the same goal, Brii is con­fi­dent about its chances of lead­ing the field on its home turf, with the aim of get­ting a mar­ket­ed drug around 2024.

Be­hind that is a once-week­ly, long-act­ing oral HIV drug that Brii hopes will give GSK’s Vi­iV and Gilead a run for their mon­ey. Li not­ed that Hong, the CEO, ac­tu­al­ly start­ed the re­search on the first long-act­ing HIV reg­i­mens while at GSK, and there’s po­ten­tial to go even longer once they prove their tech­nol­o­gy works.

That spe­cif­ic knowl­edge on long-act­ing for­mu­la­tions al­so ex­plains why Brii has de­cid­ed to tag two CNS pro­grams — one for post­par­tum de­pres­sion and the oth­er for ma­jor de­pres­sive dis­or­der — to the oth­er­wise strict­ly in­fec­tious dis­ease-fo­cused pipeline.

On top of these in-house pro­grams, Brii li­censed Chi­na rights to mul­tidrug re­sis­tant an­tibi­otics from Qpex and an ex­per­i­men­tal treat­ment for mul­ti-drug re­sis­tant TB from AN2. It al­so has a part­ner­ship in place with mi­cro­bio­me spe­cial­ist Ar­ti­zan.

As the HBV pro­gram ad­vances and the an­tibi­otics tri­als start, Li ex­pects the clin­i­cal team to grow in Chi­na — where the strat­e­gy is to fo­cus on “very large in­di­ca­tions” with enough vol­ume to over­come pric­ing bar­ri­ers. The de­vel­op­ment of Brii’s HIV and CNS drugs, on the oth­er hand, will be cen­tered around the US. They cur­rent­ly have about 60 staffers in Chi­na while the US head­count is around 40.

Thanks to Covid-19, Brii has had an crash course on clin­i­cal de­vel­op­ment, speed­ing from pre­clin­i­cal work in­to Phase III with­in a year or so and lever­ag­ing NIH re­sources so that they can keep enough mon­ey for their oth­er pro­grams. Al­though the an­ti­body, like oth­ers from Eli Lil­ly and Glax­o­SmithK­line/Vir, failed to help hos­pi­tal­ized pa­tients, Brii said it seems to re­tain neu­tral­iz­ing ac­tiv­i­ty against mul­ti­ple vari­ants. Re­sults from the Phase III AC­TIV-2 study, tar­get­ed at the out­pa­tient set­ting, are due to read out soon.

Brii al­so has Phase II tri­als un­der­way in Chi­na to ad­dress a re­cent surge and plans to make the drug avail­able to pa­tients if it works, Li said — al­though he im­plies that it won’t be the biggest pri­or­i­ty mov­ing for­ward.

“We are still com­mit­ted to fur­ther de­vel­op our dis­cov­ery and ear­ly R&D team in the US, so in that area I think the US team will al­so grow,” Li said. “So I think we will take a very bal­anced ap­proach and both sides will prob­a­bly see a sig­nif­i­cant growth in the next one or two years.”

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,800+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,800+ biopharma pros reading Endpoints daily — and it's free.

Seagen interim CEO Roger Dansey and Daiichi Sankyo CEO Sunao Manabe

Paving the way for Mer­ck­'s buy­out, Seagen los­es ar­bi­tra­tion dis­pute with Dai­ichi over ADC tech

As Seagen awaits a final buyout offer from Merck that could be in the territory of $40 billion, Seagen revealed Friday afternoon that it lost an arbitration dispute with Daiichi Sankyo relating to the companies’ 2008 collaboration around the use of antibody-drug conjugate (ADC) technology.

But that loss likely won’t matter much when it comes to Merck’s deal.

After breaking off its pact with Daiichi in mid-2015, the two companies battled over “linker” tech — a chemical bridge between an ADC’s antibody component and the cytotoxic payload — that Seagen claims Daiichi would improve upon and implement in its current generation of ADCs.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,800+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,800+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,800+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,800+ biopharma pros reading Endpoints daily — and it's free.

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.