Zai Lab Limited reports developments for a commercial-stage biopharmaceutical company with American depositary shares traded under ZLAB and ordinary shares listed in Hong Kong. The company discovers, develops, licenses and commercializes therapies for oncology, immunology, neuroscience and infectious disease, with operations based in China and the United States.
Recurring company updates include financial results, regulatory designations, clinical and preclinical data, collaborations and product updates across programs such as zocilurtatug pelitecan, ZL-1503, ZL-6201 and ZL-1222. Updates also address regional commercial products and pipeline assets including ZEJULA, VYVGART, KarXT and TIVDAK.
argenx and Zai Lab have announced an exclusive agreement for the development and commercialization of efgartigimod in Greater China. This collaboration enables argenx to expand its global reach and accelerate clinical development of autoimmune treatments. argenx will receive $175 million, including $75 million in Zai Lab equity and milestone payments. Efgartigimod targets conditions such as myasthenia gravis and has significant potential for changing treatment paradigms. Zai Lab will lead patient recruitment for global trials, enhancing access to this promising therapy for Chinese patients.
Zai Lab (NASDAQ: ZLAB) announced that Dr. Samantha Du will present at the 39th Annual J.P. Morgan Healthcare Conference on January 12, 2021, at 11:40 a.m. EST. The live presentation can be accessed through the Investor Relations section on their website, with an archived replay available for 90 days post-event.
Zai Lab focuses on developing transformative therapies for cancer, infectious, and autoimmune diseases, aiming to meet significant medical needs globally. The company partners with leading biopharmaceutical firms to expand its innovative product pipeline.
Zai Lab Limited (NASDAQ: ZLAB) announced that its drug ZEJULA (niraparib) has been included in China's National Reimbursement Drug List by the NHSA. This designation allows ZEJULA to be more accessible as a maintenance therapy for adult patients with recurrent ovarian cancer responding to platinum-based chemotherapy. Dr. Samantha Du emphasized the importance of this inclusion in achieving patient access, while William Liang noted ZEJULA's unique clinical value in China. Ovarian cancer remains a significant health concern, with over 52,000 new cases reported annually.
Zai Lab Limited (NASDAQ: ZLAB) has entered an exclusive license agreement with Cullinan Oncology for CLN-081, an EGFR inhibitor targeting exon 20 insertion mutations, in Greater China. Cullinan will receive $20 million upfront and has the potential to earn up to $211 million in milestone payments and royalties based on sales. This collaboration aims to address high unmet medical needs in lung cancer treatment in China. CLN-081 is currently in a Phase 1/2a trial for NSCLC patients who have previously undergone treatment.
Zai Lab Limited (NASDAQ: ZLAB) announced that the FDA has approved MARGENZA (margetuximab-cmkb) for the treatment of adult patients with metastatic HER2-positive breast cancer, following two or more anti-HER2 regimens. In a Phase 3 trial, MARGENZA demonstrated a 24% reduction in disease progression risk compared to trastuzumab with chemotherapy. The product is set for U.S. launch in March 2021. MARGENZA is also being developed for advanced gastric cancer. Notably, it presents adverse reactions like fatigue (57%) and nausea (33%), with a BOXED WARNING for left ventricular dysfunction.
Zai Lab Limited (NASDAQ: ZLAB) has appointed Alan Sandler, M.D., as President and Head of Global Development for Oncology. Sandler, previously of Genentech, will lead the company's global oncology efforts and support its expanding R&D initiatives. His nearly 30 years of experience in oncology includes significant contributions to innovative therapies. CEO Dr. Samantha Du expressed confidence in Sandler's leadership to enhance Zai Lab's oncology pipeline. The company aims to become a prominent global biopharma player while addressing unmet medical needs in cancer and other diseases.
Zai Lab's Phase 2 FIGHT trial for bemarituzumab shows positive results in treating FGFR2b+ gastric cancer. Key endpoints achieved statistical significance: median progression-free survival rose from 7.4 to 9.5 months, overall survival improved significantly, and overall response rate increased by 13%. The trial included 155 patients and targeted a crucial biomarker in HER2- gastric cancers. Bemarituzumab, a first-in-class therapy, could expand treatment options for cancers with FGFR2b overexpression, currently affecting about 30% of gastric cancer cases globally.
Zai Lab Limited (NASDAQ: ZLAB) announced the initiation of patient dosing in China for the global POD1UM-101 study, assessing retifanlimab for previously treated, microsatellite instability-high endometrial cancer. This study aims to enroll around 100 patients and primarily evaluates the overall response rate. Endometrial cancer, prevalent in China, has a significant unmet medical need, particularly for patients with high microsatellite instability. Retifanlimab is an investigational anti-PD1 antibody also being assessed for other cancers, with Orphan Drug Designation granted for anal cancer.
On October 28, 2020, Zai Lab announced its participation in several virtual investor conferences in November. Key events include the Citi China Investor Conference on November 5, the BioCentury 7th China Healthcare Summit and Nomura Investment Forum on November 12, and the Goldman Sachs Asia Pacific Healthcare Forum on November 17, followed by the Jefferies Virtual London Healthcare Conference on November 18. A live webcast of the Jefferies conference will be available for 90 days post-event. Zai Lab aims to deliver transformative medicines for various diseases.
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) has fully exercised its over-allotment option, resulting in the issuance of 1,584,600 additional shares. This represents 15% of the total number of Offer Shares available under the recent Global Offering. The shares will be priced at HK$562 each, generating approximately HK$890.55 million in gross proceeds. The Hong Kong Stock Exchange has approved the listing of these shares, scheduled to commence on October 16, 2020. Zai Lab aims to utilize the proceeds for purposes outlined in its Prospectus.