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.

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In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

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Up­dat­ed: Pfiz­er scoops up Glob­al Blood Ther­a­peu­tics and its sick­le cell ther­a­pies for $5.4B

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Illustration: Kim Ryu for Endpoints News

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In 1938, Rita Levi-Montalcini was forced to move her lab into her bedroom in Turin, as Mussolini’s facist government expelled Jewish people from studying or working in schools in Italy. Levi-Montalcini, then just a few years out of medical school and using sewing needles as scalpels in her makeshift lab, would soon discover nerve growth factor, or NGF, in chicken embryos.

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Albert Bourla, Pfizer CEO (Laurent Gillieron/Keystone via AP)

Break­ing: Pfiz­er in hot pur­suit of a $5B buy­out of Glob­al Blood Ther­a­peu­tics — re­port

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HHS Secretary Xavier Becerra (Patrick Semansky/AP Images)

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When Kyle Planck first suspected he might have monkeypox in late June, he went to the CDC website and found six photos of different types of lesions. And that was about it for general public information.

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