Zai Lab Limited Stock Price, News & Analysis

Zai Lab (NASDAQ: ZLAB; HKEX: 9688) reported strong Q2 2024 financial results, with net product revenue of $100.1 million, up 45% year-over-year. VYVGART sales reached $23.2 million, prompting a raised full-year guidance to exceed $80 million. The company expanded its oncology pipeline with a new ROR1 ADC program. Three product approvals were obtained in China, including XACDURO for HABP/VABP, efgartigimod SC for gMG, and AUGTYRO for ROS1+ NSCLC. Zai Lab maintains a strong cash position of $730 million as of June 30, 2024. The company expects at least four regulatory submissions to the NMPA within the next 12 months, including KarXT for schizophrenia.

Zai Lab (NASDAQ: ZLAB) and argenx announced the approval of efgartigimod alfa injection (subcutaneous injection) by China's NMPA for treating adult generalized myasthenia gravis (gMG) patients who are anti-AChR antibody positive. This marks the first and only NMPA-approved subcutaneous injectable for gMG in China, offering additional flexibility for patients.

The approval is based on the Phase 3 ADAPT-SC study, which demonstrated consistent clinical benefit and safety compared to the IV formulation. Efgartigimod SC showed a 66.4% mean total IgG reduction from baseline at day 29, compared to 62.2% with IV administration. The most common adverse event was mild to moderate injection site reactions.

This approval enhances treatment options for the estimated 170,000 gMG patients in China, allowing for a more individualized approach. Zai Lab reported 2,700 new patients starting VYVGART IV treatment in Q1 2024, highlighting the significant unmet need in the market.

Zai Lab (NASDAQ: ZLAB) announced groundbreaking research published in Cell, offering new insights into HRD-positive ovarian cancer treatment. The study, supported by Zai Lab, revealed that niraparib, a PARP inhibitor, achieves high response rates and reshapes the tumor microenvironment (TME) in HRD-positive ovarian cancer patients. Key findings include:

1. Niraparib monotherapy achieved 62.5% and 73.6% response rates per RECIST v.1.1 and GCIG CA125, respectively.
2. The study identified eTregs as key responders to HRD and neoadjuvant therapies.
3. Combining niraparib with Zai Lab's investigational CCR8 antibody, ZL-1218, showed enhanced tumor suppression in pre-clinical models.

This research opens new avenues for immunotherapy and combination treatments in HRD-positive ovarian cancer and other HRD-related cancers.

Zai Lab (NASDAQ: ZLAB; HKEX: 9688) is set to announce its second quarter 2024 financial results and recent corporate updates on August 6, 2024, after the U.S. markets close. The company will host a conference call and webcast on August 7, 2024, at 8:00 a.m. ET (8:00 p.m. HKT) to discuss these results. Interested participants must pre-register for the call via a provided registration link. Dial-in details will be shared upon registration, and a replay of the call will be available on the company's website shortly after the event.

Zai Lab announced that Harald Reinhart, M.D., President and Head of Global Development for Neuroscience, Autoimmune, and Infectious Diseases (NSAiID), will retire at the end of June. He will continue as a senior advisor for the company. Rafael Amado, M.D., currently President and Head of Global Oncology R&D, will take over all Global R&D responsibilities following Dr. Reinhart's retirement.

Dr. Reinhart has nearly 50 years of experience, joining Zai Lab 10 years ago and significantly expanding its NSAiID capabilities. Dr. Amado will now oversee Zai Lab’s entire R&D pipeline across therapeutic areas. He has held senior roles in various pharmaceutical and biotech companies, contributing to the discovery and development of numerous innovative therapies.

Zai Lab has begun a global Phase 2 clinical trial to evaluate ZL-1102, a topical treatment for chronic plaque psoriasis (CPP). ZL-1102 is the first of Zai's internally developed drugs to reach Phase 2, demonstrating the company's global research and development capabilities. This investigational therapy targets the IL-17 cytokine and is designed for mild-to-moderate CPP, unlike other treatments that address more severe cases via systemic administration. The trial will involve 250 patients over 16 weeks, with the primary endpoint being a 75% reduction in the Psoriasis Area Severity Index (PASI) score at week 16. Secondary objectives include efficacy, safety, tolerability, pharmacokinetics, and anti-drug antibody response.

Zai Lab and Innoviva Specialty Therapeutics have received approval from China's National Medical Products Administration (NMPA) for XACDURO® (sulbactam-durlobactam), a new treatment for hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by Acinetobacter baumannii-calcoaceticus complex in adults. This approval is based on positive results from the global Phase 3 ATTACK trial, which demonstrated XACDURO's non-inferiority to colistin in reducing 28-day all-cause mortality and significantly improving clinical cure rates. The drug addresses the urgent need for effective treatments against carbapenem-resistant bacterial strains, which account for approximately 74% of Acinetobacter infections in China. This milestone follows the FDA's approval of XACDURO in the U.S. in May 2023, marking it as the first FDA-approved pathogen-targeted therapy for this condition.

Zai Lab (NASDAQ: ZLAB; HKEX: 9688) announced its senior management team participation in three key investor conferences in May and June 2024. The events include the J.P. Morgan 20th Annual Global China Summit on May 23 in Shanghai, the Jefferies Global Healthcare Conference on June 5 in New York, and the Goldman Sachs 45th Annual Global Healthcare Conference on June 12 in Miami Beach. These conferences offer Zai Lab an opportunity to discuss its strategies, recent developments, and future plans with global investors.

Zai Lab announced the acceptance of a supplemental Biologics License Application (sBLA) for efgartigimod alfa injection (subcutaneous) for treating chronic inflammatory demyelinating polyneuropathy (CIDP) in China. The application received priority review from the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) on May 11, 2024. The decision is based on positive results from the ADHERE trial, showing a 69% reduction in relapse rates and 78% clinical improvement in Chinese participants. CIDP affects about 50,000 patients in China, with treatment options. The milestone reflects Zai Lab's expertise in developing and commercializing innovative treatments in China, with ongoing collaboration with argenx.