Zai Lab Limited (NASDAQ: ZLAB), a China and U.S.-based innovative commercial stage biopharmaceutical company, today announced financial results for the twelve months ended December 31, 2019 and corporate updates.
"Coinciding with the celebration of our five-year anniversary, 2019 was a year of many important achievements for Zai Lab," said Dr. Samantha Du, Founder and Chief Executive Officer of Zai Lab. "Some key milestones achieved include the marketing approval obtained for ZEJULA® in China and our submissions for regulatory approval in China for Optune® and omadacyline in China. We also entered into licensing collaborations with Deciphera and Incyte, expanded our commercial platform in China, launched commercial activities for ZEJULA and Optune in Hong Kong, S.A.R., China and further enhanced our in-house R&D capabilities. We are proud of our global reputation as a biotech pioneer and a partner-of-choice in China, and we continued to deliver exceptional execution across global and local clinical development, regulatory affairs, business development and operational expansion.
Key Product Highlights and Expected Milestones
Oncology
ZEJULA® (niraparib)
ZEJULA is a highly potent and selective oral, once-daily small molecule poly (ADP-ribose) PARP 1/2 inhibitor.
- In March 2020, Zai Lab announced that the China National Medical Products Administration (NMPA) has accepted its supplemental New Drug Application (sNDA) for ZEJULA for first-line maintenance treatment of patients with ovarian cancer.
- Based on IQVIA data, ZEJULA was the leading PARP inhibitor with market share in Hong Kong, S.A.R., China of 71% by value for 2019. ZEJULA was also ranked amongst the top 5 oncology drugs launches in Hong Kong, S.A.R., China after 2014 behind Keytruda®, Opdivo®, Tecentriq® and Tagrisso® based on first full-year revenue.
- In February 2020, Zai Lab dosed the first patient in the Phase 1b study of niraparib with MGD013, a first-in-class PD1/LAG-3 bispecific antibody, in advanced or metastatic gastric cancer.
- In February 2020, Zai Lab terminated the Phase 3 study of niraparib as first-line maintenance treatment of patients with small-cell lung cancer due to changes in the treatment landscape in China.
- In January 2020, Zai Lab launched ZEJULA in China.
- In December 2019, Zai Lab announced that the China NMPA approved the NDA for ZEJULA as maintenance treatment of patients with recurrent ovarian cancer. This approval represents the fastest approval time by the NMPA in 2019 for a locally manufactured, category 1 oncology drug.
- In November 2019, Zai Lab completed enrollment of the China Phase 3 PRIME study of ZEJULA in patients with first-line ovarian cancer.
Expected Milestones
- Initiate registrational bridging trial for late-line ovarian cancer treatment in second half of 2020
- Expect final clinical data from the NORA study, the pivotal trial for maintenance therapy of Chinese patients with recurrent ovarian cancer in first half of 2020
- Continue to collaborate with our Partner GSK on additional indications and opportunities
Tumor Treating Fields
Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt cell division, inhibiting tumor growth and potentially causing cancer cells to die.
- In January 2020, Zai Lab announced that the first patient has been enrolled in a Phase 2 pilot clinical trial evaluating the safety and efficacy of Tumor Treating Fields in combination with chemotherapy as first-line treatment in patients with gastric adenocarcinoma.
- In September 2019, the NMPA accepted the Marketing Authorization Application (MAA) of Optune, a Tumor Treating Fields delivery system for the treatment of glioblastoma (GBM).
Expected Milestones
- Potential China GBM MAA approval with trial waiver in first half of 2020
- Complete enrollment of the Phase 2 pilot clinical trial in first-line gastric adenocarcinoma in 2020
- File MAA for malignant pleural mesothelioma in China
- Partner Milestone: ...
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