Zai Lab, MacroGenics enters into collaboration to develop, commercialize » 07:3906/1606/16/21
Zai Lab (ZLAB) and…
Zai Lab (ZLAB) and MacroGenics (MGNX) announced that the companies have entered into an exclusive collaboration and license agreement involving up to four immuno-oncology molecules. The first collaboration program covers a lead research molecule that incorporates MacroGenics' DART platform and binds CD3 and an undisclosed target that is expressed in multiple solid tumors. The next-generation CD3 component of the DART bispecific molecule has been designed to minimize cytokine-release syndrome while maintaining anti-tumor cytolytic activity. The second collaboration program will cover a target to be designated by MacroGenics. For both molecules, Zai receives commercial rights in Greater China, Japan, and Korea and MacroGenics receives commercial rights in all other territories. For the lead molecule, Zai Lab receives an option upon reaching a predefined clinical milestone to convert the regional arrangement into a global 50/50 profit share. Zai Lab also obtains exclusive, global licenses from MacroGenics to develop, manufacture and commercialize two additional molecules. For the four programs, each company will contribute intellectual property to generate either CD3- or CD47-based bispecific antibodies. Under the terms of the agreement, MacroGenics receives initial consideration from Zai Lab of $55M, including an upfront payment of $25M and an equity investment of $30M in MacroGenics' common stock at $31.30 per share. In addition, MacroGenics is eligible to receive up to $1.4B in potential development, regulatory and commercial milestone payments for the four programs. If products from the collaboration are commercialized, MacroGenics would also receive royalties on annual net sales in Zai Lab's territories.
|Over a week ago|
Mirati Therapeutics, Zai Lab enter collaboration for adagrasib in Greater China » 07:5206/0106/01/21
Mirati Therapeutics (MRTX) and Zai Lab (ZLAB) announced the companies have entered into a collaboration and license agreement for adagrasib, a small-molecule KRASG12C inhibitor, in Greater China. Under the terms of the agreement, Zai Lab obtains the right to research, develop, manufacture and exclusively commercialize adagrasib in Greater China. Zai Lab will support accelerated enrollment in key global, registration-enabling clinical trials of adagrasib in patients with cancer who have a KRASG12C mutation. Mirati has an option to co-commercialize in Greater China and retains full and exclusive rights to adagrasib in all countries outside of Greater China. Mirati will receive a $65M upfront payment, with the potential to receive up to an additional $273M in development, regulatory and sales-based milestone payments. Mirati is also eligible to receive high-teen- to low-twenties-percent tiered royalties based on annual net sales of adagrasib in Greater China.
Mirati and Zai Lab enter into collaboration and license agreement for adagrasib » 07:3206/0106/01/21
Mirati Therapeutics (MRTX) and Zai Lab (ZLAB) announced the companies have entered into a collaboration and license agreement for adagrasib, a small-molecule KRASG12C inhibitor, in Greater China. Under the terms of the agreement, Zai Lab obtains the right to research, develop, manufacture and exclusively commercialize adagrasib in Greater China. Zai Lab will support accelerated enrollment in key global, registration-enabling clinical trials of adagrasib in patients with cancer who have a KRASG12C mutation. Mirati has an option to co-commercialize in Greater China and retains full and exclusive rights to adagrasib in all countries outside of Greater China. Mirati will receive a $65M upfront payment, with the potential to receive up to an additional $273 million in development, regulatory and sales-based milestone payments. Mirati is also eligible to receive high-teen- to low-twenties-percent tiered royalties based on annual net sales of adagrasib in Greater China.
Zai Lab announces first patient treated in China in Phase 2 TRIDENT-1 study » 07:3305/2805/28/21
Zai Lab (ZLAB) announced…
Zai Lab (ZLAB) announced dosing of the first patient in China in the registrational Phase 2 portion of TRIDENT-1 study of repotrectinib being conducted by its partner Turning Point Therapeutics (TPTX) and Zai Lab in patients with ROS1+ advanced non-small cell lung cancer and NTRK+ advanced solid tumors. Zai Lab has an exclusive license agreement with Turning Point for the development and commercialization of repotrectinib in Greater China. The registrational Phase 2 portion of TRIDENT-1 study is a multi-center trial evaluating repotrectinib for the treatment of patients with ROS1+ advanced NSCLC as well as patients with NTRK+ advanced solid tumors. The primary endpoint of the Phase 2 portion of the trial is overall response rate assessed by Blinded Independent Central Review. Secondary endpoints include duration of response, progression free survival, safety and tolerability. Zai Lab is enrolling patients in Greater China, while Turning Point is enrolling patients in other regions of the world. Turning Point disclosed on May 5 that the FDA recently guided that a type B meeting should be requested to discuss topline BICR results of cohort 1 of the registrational TRIDENT-1 study when responders have been followed for at least six months past onset of response. Turning Point believes it may be in a position to discuss the topline results from patients treated within EXP-1 with the FDA during the first quarter of 2022.
Zai Lab announces first patient treated in Greater China in METIS Phase 3 trial » 09:2505/2405/24/21
Zai Lab Limited (ZLAB)…
Zai Lab Limited (ZLAB) announced treatment of the first patient in Greater China in the METIS trial, a Phase 3 pivotal trial being conducted by Zai's partner NovoCure Limited (NVCR) to study radiosurgery plus Tumor Treating Fields compared to radiosurgery alone for the treatment of brain metastases from non-small cell lung cancer. The METIS trial is a pivotal, randomized, controlled Phase 3 trial designed to test the efficacy and safety of TTFields, generated by a medical device, the NovoTTF-100M System, in patients with 1-10 newly diagnosed brain metastasis from NSCLC. TTFields are administered to patients concomitantly with the best standard of care treatments that would normally be used to treat lung cancer. The trial is expected to enroll 270 patients randomized 1:1 to receive, following radiosurgery, either TTFields at a frequency of 150kHz plus supportive care or supportive care alone. The primary endpoint is time to first cerebral progression. Secondary endpoints include, among others, time to neurocognitive failure, overall survival, and radiological response rate.
|Over a month ago|
Zai Lab reports Q1 EPS ($2.64), two est. ($1.58) » 07:4405/1005/10/21
Reports Q1 revenue…
Reports Q1 revenue $20.1M, two est. $29.89M. "Zai Lab continued to execute well in all aspects of the business during the first quarter," said Dr. Samantha Du, Founder, Chairperson and Chief Executive Officer of Zai Lab. "We entered into several strategic collaborations to further strengthen our gastric and lung cancer disease strongholds; significantly bolstered our autoimmune franchise with an exclusive agreement with argenx for efgartigimod, a pipeline-in-a-product opportunity; advanced numerous clinical programs toward key data readouts; gained approval of QINLOCK by the National Medical Products Administration, our third innovative oncology product approval in the last 15 months in China and the first commercial product in what we expect to become a world-class gastric cancer franchise; and generated solid revenue growth, in part from increased volume of ZEJULA driven by its recent inclusion on the National Reimbursement Drug List. In addition, we recently received encouraging news on several key assets from our partners. The Biologics License Application filing of efgartigimod in generalized myasthenia gravis was accepted by the U.S. Food and Drug Administration. The Phase 3 pivotal LUNAR trial of Tumor Treating Fields in non-small cell lung cancer was recommended to continue with reduced sample size based on an accelerated interim analysis. Bemarituzumab was granted Breakthrough Therapy Designation by the FDA as first-line treatment for gastric cancer patients who overexpress FGFR2b. With the completion of our recent global public offering with gross proceeds of nearly $860 million, we significantly strengthened our capital position. This new capital will allow us to accelerate our growth by entering into additional strategic partnerships, advancing our clinical development pipeline, and scaling our commercial and R&D organizations to drive strong revenue growth and enhance our global pipeline. We remain on target to advance all stages of our product pipeline throughout 2021. We continue to expect approval of Nuzyra for community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections by the NMPA. We plan to file margetuximab for Her2-positive breast cancer, Tumor Treating Fields for mesothelioma and ZEJULA for late-line ovarian cancer in China. We are engaging with the NMPA on the regulatory filing strategy for efgartigimod in gMG in China. And we anticipate numerous data readouts, including for Tumor Treating Fields in liver cancer and ovarian cancer, for QINLOCK in second-line GIST, for margetuximab in gastric cancer, for CLN-081 in NSCLC and for TPX-0022 in NSCLC and gastric cancer. n our mission to address serious unmet medical needs for patients in China and around the world, we believe that we have built a sustainable platform that we can leverage," Dr. Du concluded. "Our team continues to deliver on our aggressive growth objectives. I believe that the future of Zai Lab has never been brighter."
Zai Lab 4.78M share Secondary priced at $150.00 » 19:4204/2004/20/21
The deal priced below the…
The deal priced below the last closing price of $150.77. JPMorgan, Goldman Sachs, Jefferies, Citi, SVB Leerink and Guggenheim are acting as joint book running managers for the offering.
Fly Intel: After-Hours Movers » 18:3004/1904/19/21
IBM, HXL, WTFC, CCK, UAL, STLD, FUTU, ZLAB
Check out this evening's…
Zai Lab files to sell $750M in ADSs » 16:0904/1904/19/21
J.P. Morgan Securities…
J.P. Morgan Securities LLC, Goldman Sachs & Co. LLC, Jefferies LLC, Citigroup Global Markets Inc., SVB Leerink LLC and Guggenheim Securities, LLC are acting as joint book-running managers for the ADS offering. J.P. Morgan Securities plc, Goldman Sachs (Asia) L.L.C., Jefferies Hong Kong Limited, Citigroup Global Markets Limited and Guggenheim Securities, LLC are acting as joint book-running managers in respect of any ordinary shares issued to investors electing to receive ordinary shares in lieu of ADSs.
Zai Lab price target raised to $192 from $183 at SVB Leerink » 14:2304/1404/14/21
SVB Leerink analyst…
SVB Leerink analyst Jonathan Chang raised the firm's price target on Zai Lab to $192 from $183 and keeps an Outperform rating on the shares following what he calls the "encouraging" Optune update from partner Novocure (NVCR) in the LUNAR phase 3 non-small cell lung cancer trial. Chang is updating his model to reflect a faster timeline as well as increasing his view on the probability of success for the Optune lung cancer opportunity to 90% from 65%.