Samantha Du, Zai Lab CEO (Zai Lab)

Saman­tha Du's Zai Lab sets its am­bi­tions sky high, look­ing to raise $750M to fu­el its li­cens­ing busi­ness mod­el

Look­ing to cap­i­tal­ize on a bustling Chi­nese drug mar­ket, up­start biotechs like Saman­tha Du’s Zai Lab have made a killing in-li­cens­ing for­eign mol­e­cules as well as de­vel­op­ing their own home­grown as­sets. Now, with even more growth in mind, Zai Lab has of­fered up a healthy chunk of shares on the US mar­ket to fu­el its am­bi­tions.

Zai Lab will of­fer $750 mil­lion in US de­pos­i­to­ry shares as part of a ma­jor cash raise to keep dri­ving its in-li­cens­ing busi­ness en­gine as well as ad­vance its suite of clin­i­cal pro­grams, the Chi­nese biotech said this week.

Ac­cord­ing to its 424(b)(f) prospec­tus, Zai Lab will use rough­ly 30% of those pro­ceeds to­ward “cor­po­rate de­vel­op­ment and li­cens­ing op­por­tu­ni­ties,” the biotech said, look­ing to build on its busi­ness mod­el in-li­cens­ing mol­e­cules for use in Chi­na.

So far, that busi­ness plan has proved lu­cra­tive, and Zai Lab has inked big­ger and big­ger li­cens­ing pacts along the way. Back in Jan­u­ary, Du’s com­pa­ny inked a deal with ar­genx worth a cool $175 mil­lion for re­gion­al rights to au­toim­mune drug ef­gar­tigi­mod in Chi­na, Tai­wan, Hong Kong and Macau. In ex­change, ar­genx CEO Tim Van Hauw­er­meiren got $75 mil­lion up­front in Zai Lab stock, an­oth­er $75 mil­lion as a guar­an­tee from Zai Lab for their cost-shar­ing arrange­ment, and an­oth­er $25 mil­lion mile­stone tied to US ap­proval of the late-stage drug.

Zai Lab is al­so the ex­clu­sive Chi­nese li­cense hold­er for Am­gen’s be­mar­ituzum­ab, which just earned the FDA’s break­through des­ig­na­tion in gas­tric can­cer. The mol­e­cule came over as part of Am­gen’s ac­qui­si­tion of Five Prime in March.

In ad­di­tion to adding to its cash pile for po­ten­tial li­cens­es, Zai Lab al­so plans to use a big chunk of its pro­ceeds to ad­vance a suite of drugs through clin­i­cal tri­als — al­lo­cat­ing about 30% of the $750 mil­lion to that ef­fort. One of those projects is a col­lab­o­ra­tion with Novo­cure work­ing on us­ing elec­tri­cal fields to treat non-small cell lung can­cer. The part­ners re­cent­ly scaled back a Phase III tri­al af­ter an in­de­pen­dent da­ta mon­i­tor­ing com­mit­tee saw enough to go on to slow en­roll­ment.

As for the rest of the planned cash raise? Zai Lab will ded­i­cate 20% to ex­pand their com­mer­cial ef­forts, 15% to “en­hance our glob­al pipeline” and about 5% for “work­ing cap­i­tal and oth­er gen­er­al cor­po­rate pur­pos­es,” the biotech said.

Of course, all those lev­els are not set in stone, and Zai Lab is re­serv­ing the right to switch those per­cent­ages around as needs arise — par­tic­u­lar­ly based on progress in the clin­ic.

“Due to the many vari­ables in­her­ent to the de­vel­op­ment of our drug can­di­dates at this time, such as the tim­ing of pa­tient en­roll­ment and evolv­ing reg­u­la­to­ry re­quire­ments, we can­not cur­rent­ly pre­dict the stage of de­vel­op­ment we ex­pect to achieve for our pre-clin­i­cal and clin­i­cal tri­al and drug can­di­dates with the net pro­ceeds of this of­fer­ing,” Zai Lab said.

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

Credit: Shutterstock

How Chi­na turned the ta­bles on bio­phar­ma's glob­al deal­mak­ing

Fenlai Tan still gets chills thinking about the darkest day of his life.

Three out of eight lung cancer patients who received a tyrosine kinase inhibitor developed by his company, Betta Pharma, died in the span of a month. Tan, the chief medical officer, was summoned to Peking Union Medical College Hospital, where the head of the clinical trial department told him that the trial investigators would be conducting an autopsy to see if the patients had died of the disease — they were all very sick by the time they enrolled — or of interstitial lung disease, a deadly side effect tied to the TKI class that’s been reported in Japan.

Peter Nell, Mammoth Biosciences CBO

UP­DAT­ED: Jen­nifer Doud­na spin­out inks a Mam­moth CRISPR deal with Ver­tex worth near­ly $700M

When a company gets its start in gene editing pioneer Jennifer Doudna’s lab, it’s bound to make headlines. But three years in, the fanfare still hasn’t died down for Mammoth Biosciences. Now, the Brisbane, CA-based company is cheering on its first major R&D pact.

Mammoth unveiled a nearly $700 million deal with Vertex on Tuesday morning, good for the development of in vivo gene therapies for two mystery diseases. The stars of the show are Mammoth’s ultra-small CRISPR systems, including two Cas enzymes licensed from Doudna’s lab over the past couple years, Cas14 and Casɸ.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,800+ biopharma pros reading Endpoints daily — and it's free.

James Peyer, Cambrian CEO

Brent Saun­ders joins $100M Se­ries C for a com­pa­ny out to be the Bridge­Bio of ag­ing

About a year ago, James Peyer, a CEO and co-founder of the little known longevity biotech Cambrian Biopharma, was trying to find some R&D talent last year when he met with more than a bit of experience in that department: David Nicholson, the former R&D chief of the erstwhile pharma giant Allergan.

It turned out Nicholson already had an interest in Peyer’s field. In their Allergan days, he and COO Brent Saunders held weekly meetups where they tried to figure out how to take the company’s dominance in aesthetics — which, until recently, was often what people meant by anti-aging science — and expertise with more traditional drug development, and use it to make drugs that extend people’s lifespan.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,800+ biopharma pros reading Endpoints daily — and it's free.

An­gion's or­gan dam­age drug strikes out again, this time in high-risk kid­ney trans­plant pa­tients

After flopping a test in Covid-19 earlier this year, Angion’s lead organ damage drug has now hit the skids again in kidney transplant patients.

Angion and partner Vifor Pharma’s ANG-3777 failed to beat out placebo in terms of improving eGFR, a measure of kidney function, in patients who had received a deceased donor kidney transplant and were at high risk of developing what is known as delayed graft function, according to Phase III results released Tuesday.

(Photo courtesy Pfizer)

FDA's vac­cine ad­comm votes al­most unan­i­mous­ly in fa­vor of Pfiz­er's Covid-19 vac­cine for younger chil­dren

The FDA’s Vaccines and Related Biological Products Advisory Committee on Tuesday voted 17-0, with one panelist abstaining, that the benefits of the Pfizer-BioNTech Covid-19 vaccine outweigh the risks for children between the ages of five and 12.

The vote will likely trigger a process that could allow the shots to begin rolling out as early as next week.

The vaccine, which is one-third of the adult Pfizer dose, proved to be about 90% effective in a placebo-controlled trial in which about 1,500 kids in this age range received the vaccine, and only about 12% of those receiving the vaccine had any adverse event. All serious adverse events in the trial were unrelated to the vaccine.

Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Mod­er­na chips in fur­ther on African vac­cine sup­ply — but ad­vo­cates are call­ing for even more

In a sign of its growing commitment to the continent, Moderna will supply up to 110 million doses of its Covid-19 vaccine to the African Union, the company announced Tuesday. And CEO Stéphane Bancel said it’s just the first step.

“We believe our vaccine can play an important role in addressing the needs of low-income countries given its combination of high Phase 3 efficacy against COVID-19, strong durability in the real-world evidence, and superior storage and handling conditions. We recognize that access to COVID-19 vaccines continues to be a challenge in many parts of the world and we remain committed to helping to protect as many people as possible around the globe,” Bancel said in a statement.

An image of Alzheimer's brain tissue. The red show gingipains, a protein from P. gingivalis, intermixing with neurons (yellow) and glial cells (green)

An Alzheimer's dark­horse fails its first big tri­al, but of­fers hope for a long-over­looked hy­poth­e­sis

Three years ago, Cortexyme emerged out of obscurity with some big-name backers and an unorthodox approach to treating Alzheimer’s.

They moved their drug into a pivotal study the next year, offering one of the first major tests for a hypothesis that has fluttered on the outskirts of Alzheimer’s research for decades: that, in many cases, the disease is driven by infectious agents — the havoc they wreak in the brain and the inflammation the body uses to try to fend them off. And that quashing the infection could slow patients’ cognitive decline.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,800+ biopharma pros reading Endpoints daily — and it's free.

Ugur Sahin, AP Images

As pres­sure to share tech­nol­o­gy mounts, BioN­Tech se­lects Rwan­da for lat­est vac­cine site

BioNTech’s first mRNA-based vaccine site in Africa will call Rwanda home, and construction is set to start in mid-2022, the company announced Tuesday at a public health forum.

The German company signed a memorandum of understanding, after a meeting between Rwanda’s Minister of Health, Daniel Ngamije, Senegal’s Minister of Foreign Affairs Aïssata Tall Sall, and senior BioNTech officials. Construction plans have been finalized, and assets have been ordered. The agreement will help bring end-to-end manufacturing to Africa, and as many as several hundred million doses of vaccines per year, though initial production will be more modest.