Lan Huang, BeyondSpring CEO

Play­ing a sur­pris­ing­ly hot hand, Be­yond­Spring nails a $200M Chi­na deal in wake of a piv­otal suc­cess

Be­yond­Spring has been on a roll late­ly.

Just a few weeks ago, the New York-based biotech shocked in­vestors and an­a­lysts with how ef­fec­tive the com­pa­ny’s mol­e­cule, plinab­u­lin, was on can­cer pa­tients’ longevi­ty. Now, the biotech has forged a deal with a ma­jor play­er in the Asian mar­ket for the drug.

Be­yond­Spring an­nounced this morn­ing a com­mer­cial­iza­tion and co-de­vel­op­ment agree­ment be­tween its Chi­nese sub­sidiary Wanchun­bu­lin and Chi­na’s Jiang­su Hen­grui Phar­ma­ceu­ti­cals.

Jiang­su Hen­grui will have ex­clu­sive com­mer­cial and co-de­vel­op­ment rights for plinab­u­lin in Chi­na and near­by re­gions, which in­clude Hong Kong, Macau and Tai­wan. Be­yond­Spring will re­tain 100% of the glob­al rights for plinab­u­lin out­side of those re­gions.

Plinab­u­lin, in com­bi­na­tion with G-CSF, is cur­rent­ly get­ting a pri­or­i­ty re­view by the FDA and is un­der re­view by the Chi­na Na­tion­al Med­ical Prod­ucts Ad­min­is­tra­tion for the pre­ven­tion of chemother­a­py-in­duced neu­trope­nia. Be­yond­Spring an­nounced pos­i­tive Phase III re­sults ear­li­er this month from its study of plinab­u­lin in com­bi­na­tion with chemother­a­py drug do­c­etax­el for the treat­ment of 2nd and 3rd line non-small cell lung can­cer (NSCLC), specif­i­cal­ly EGFR wild type.

That study re­vealed that just over 10% of pa­tients on plinab­u­lin sur­vived 4 years on the drug, com­pared to none who re­ceived the place­bo. Be­yond­Spring’s stock price has sky­rock­et­ed af­ter the com­pa­ny’s an­nounce­ment – from $9.63 on Aug. 3 to $29.35 as of this morn­ing.

To­day’s new deal on­ly re­in­forces Be­yond­Spring’s be­lief in the po­ten­tial of their seem­ing­ly block­buster mol­e­cule.

“We are thrilled to con­tin­ue ex­e­cut­ing on our glob­al com­mer­cial­iza­tion plans by en­ter­ing in­to this part­ner­ship with Hen­grui,” said Lan Huang, co-founder, chair and CEO of Be­yond­Spring. “We be­lieve there are sig­nif­i­cant syn­er­gies in this part­ner­ship and be­lieve it po­si­tions plinab­u­lin to be de­vel­oped for ad­di­tion­al in­di­ca­tions and to ac­cel­er­ate and in­crease peak sales in Chi­na.”

Lian­shan Zhang, pres­i­dent of glob­al R&D and mem­ber of the board of di­rec­tors for Hen­grui, com­ment­ed that “[t]reat­ment and pre­ven­tion of chemother­a­py-in­duced hema­to­log­i­cal tox­i­c­i­ties still rep­re­sent a huge un­met med­ical need. We look for­ward to work­ing with Be­yond­Spring to pre­pare the NDA fil­ing for the NSCLC in­di­ca­tion in Chi­na and to ex­plore ad­di­tion­al an­ti-can­cer in­di­ca­tions to ben­e­fit can­cer pa­tients in need.”

Wanchun­bu­lin will re­tain the man­u­fac­tur­ing rights of plinab­u­lin and will book all plinab­u­lin rev­enue in Chi­na, Hong Kong, Macau and Tai­wan. Hen­grui will re­ceive a pre-de­ter­mined per­cent­age of the net sales each quar­ter.

As com­pen­sa­tion, Wanchun­bu­lin will re­ceive an up­front pay­ment of 200M RMB, or just over $30 mil­lion USD. An ad­di­tion­al amount of up to 1.1 B RMB, or around $170 mil­lion USD, will be giv­en, pend­ing reach­ing reg­u­la­to­ry and sales mile­stones. Hen­grui will be re­spon­si­ble for all costs as­so­ci­at­ed with com­mer­cial­iza­tion of plinab­u­lin in those spe­cif­ic Asian mar­kets.

Wanchun­bu­lin will take re­spon­si­bil­i­ty for 100% of the clin­i­cal and reg­u­la­to­ry costs for the first two in­di­ca­tions for plinab­u­lin: pre­ven­tion of CIN and 2nd/3rd line treat­ment of NSCLC (EGFR wild type). Hen­grui will fund 50% of the clin­i­cal de­vel­op­ment costs for ad­di­tion­al in­di­ca­tions for plinab­u­lin. Wanchun­bu­lin will al­so con­tin­ue lead­ing pro­to­col de­sign and de­vel­op­ment for ad­di­tion­al in­di­ca­tions.

In con­nec­tion with the sign­ing of the col­lab­o­ra­tion, Hen­grui will make an eq­ui­ty in­vest­ment at 100M RMB, ap­prox­i­mate­ly $15 mil­lion USD, in­to the Wanchun­bu­lin sub­sidiary at a pre-mon­ey val­u­a­tion of 3.6B RMB, or $556 mil­lion USD.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Jay Bradner (Jeff Rumans for Endpoints News)

Div­ing deep­er in­to in­her­it­ed reti­nal dis­or­ders, No­var­tis gob­bles up an­oth­er bite-sized op­to­ge­net­ics biotech

Right about a year ago, a Novartis team led by Jay Bradner and Cynthia Grosskreutz at NIBR swooped in to scoop up a Cambridge, MA-based opthalmology gene therapy company called Vedere. Their focus was on a rather narrow market niche: inherited retinal dystrophies that include a wide range of genetic retinal disorders marked by the loss of photoreceptor cells and progressive vision loss.

But that was just the first deal that whet their appetite.

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Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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FDA hands ac­cel­er­at­ed nod to Seagen, Gen­mab's so­lo ADC in cer­vi­cal can­cer, but com­bo stud­ies look even more promis­ing

Biopharma’s resident antibody-drug conjugate expert Seagen has scored a clutch of oncology approvals in recent years, finding gold in what are known as “third-gen” ADCs. Now, another of their partnered conjugates is ready for prime time.

The FDA on Monday handed an accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv, or “TV”) in second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy, the companies said in a release.

Dave Lennon, former president of Novartis Gene Therapies

Zol­gens­ma patent spat brews be­tween No­var­tis and Re­genxbio as top No­var­tis gene ther­a­py ex­ec de­parts

Regenxbio, a small licensor of gene therapy viral vectors spun out from the University of Pennsylvania, is now finding itself in the middle of some major league patent fights.

In addition to a patent suit with Sarepta Therapeutics from last September, Novartis, is now trying to push its smaller partner out of the way. The Swiss biopharma licensed Regenxbio’s AAV9 vector for its $2.1 million spinal muscular atrophy therapy Zolgensma.

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Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

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Rafaèle Tordjman (Jeito Capital)

Con­ti­nu­ity and di­ver­si­ty: Rafaèle Tord­j­man's women-led VC firm tops out first fund at $630M

For a first-time fund, Jeito Capital talks a lot about continuity.

Rafaèle Tordjman had spotlighted that concept ever since she started building the firm in 2018, promising to go the extra mile(s) with biotech entrepreneurs while pushing them to reach patients faster.

Coincidentally, the lack of continuity was one of the sore spots listed in a report about the European healthcare sector published that same year by the European Investment Bank — whose fund is one of the LPs, alongside the American pension fund Teacher Retirement System of Texas and Singapore’s Temasek, to help Jeito close its first fund at $630 million (€534 million). As previously reported, Sanofi had chimed in €50 million, marking its first investment in a French life sciences fund.

Mi­rati tri­umphs again in KRAS-mu­tat­ed lung can­cer with a close­ly watched FDA fil­ing now in the cards

After a busy weekend at #ESMO21, which included a big readout for its KRAS drug adagrasib in colon cancer, Mirati Therapeutics is ready to keep the pressure on competitor Amgen with lung cancer data that will undergird an upcoming filing.

In topline results from a Phase II cohort of its KRYSTAL-1 study, adagrasib posted a response rate of 43% in second-line-or-later patients with metastatic non-small cell lung cancer containing a KRAS-G12C mutation, Mirati said Monday.