Zai Lab Limited American Depositary Shares - ZLAB STOCK NEWS

Zai Lab (ZLAB) and Novocure announced positive results from their Phase 3 PANOVA-3 trial, evaluating Tumor Treating Fields (TTFields) therapy combined with gemcitabine and nab-paclitaxel for pancreatic cancer. The trial met its primary endpoint, showing a statistically significant improvement in median overall survival of 16.20 months compared to 14.16 months in the control group (hazard ratio=0.819; P=0.039). The treatment demonstrated increasing survival benefits over time, with a 13% improvement at 12 months and 33% at 24 months. Both companies plan to seek regulatory approvals in their respective markets.

Zai Lab announced significant updates to China's 2024 National Reimbursement Drug List (NRDL). AUGTYRO® (repotrectinib) has been included for treating ROS1-positive non-small cell lung cancer. The NRDL also renewed NUZYRA® (omadacycline) for bacterial infections and QINLOCK® (ripretinib) for advanced gastrointestinal stromal tumor. These inclusions will expand patient access and provide more affordable treatment options across China. The company plans to launch AUGTYRO by the end of 2024, marking its sixth product in the NRDL.

Zai Lab (NASDAQ: ZLAB) and Pfizer announced a strategic collaboration for XACDURO® (sulbactam-durlobactam) in mainland China through November 2028. Pfizer will exclusively handle commercialization activities for XACDURO®, leveraging its anti-infective infrastructure. XACDURO® is the only antimicrobial specifically developed for treating carbapenem-resistant Acinetobacter baumannii (CRAB) in hospital-acquired and ventilator-associated bacterial pneumonia. In China, where Acinetobacter baumannii resistance to carbapenem antibiotics has reached approximately 74%, this collaboration aims to accelerate patient access to this critical therapy.

Zai Lab (NASDAQ: ZLAB; HKEX: 9688) announced the closing of its public offering of 9,019,607 American Depositary Shares (ADSs) at $25.50 per ADS, including the full exercise of underwriters' option for additional 1,176,470 ADSs. The offering is expected to generate approximately $230 million in gross proceeds before deducting underwriting discounts and commissions. Goldman Sachs, Jefferies, and Leerink Partners served as joint book-running managers for the offering, which was made under an automatically effective S-3ASR registration statement.

Zai Lab (NASDAQ: ZLAB; HKEX: 9688) has announced the pricing of its public offering of 7,843,137 American depositary shares (ADSs) at $25.50 per ADS. Each ADS represents ten ordinary shares. The offering is expected to generate approximately $200 million in gross proceeds before deducting costs. The company granted underwriters a 30-day option to purchase up to an additional 1,176,470 ADSs. The offering is expected to close around November 18, 2024. Goldman Sachs, Jefferies, and Leerink Partners are serving as joint book-running managers. Proceeds will be used for general corporate purposes.

Zai Lab (NASDAQ: ZLAB; HKEX: 9688) has announced a proposed public offering of $200.0 million in American Depositary Shares (ADSs). Each ADS represents ten ordinary shares with a $0.000006 par value. The company plans to grant underwriters a 30-day option to purchase up to an additional 15% of ADSs at the public offering price less underwriting discounts. Goldman Sachs, Jefferies, and Leerink Partners are acting as joint book-running managers. The proceeds will be used for general corporate purposes. The offering is being made through a shelf registration statement on Form S-3ASR.

Zai Lab (NASDAQ: ZLAB) reported strong Q3 2024 financial results with net product revenue growing 47% year-over-year to $101.8 million. The growth was primarily driven by VYVGART sales, which reached $27.3 million. ZEJULA sales increased 16% to $48.2 million, while NUZYRA sales grew 82% to $10.0 million. The company reported a net loss of $41.7 million, improved from $69.2 million in Q3 2023. Cash position stood at $716.1 million as of September 30, 2024. The company announced positive results from KarXT's China bridging study in schizophrenia, with regulatory submission expected in early 2025.

Zai Lab and argenx announced NMPA approval of VYVGART Hytrulo for treating chronic inflammatory demyelinating polyneuropathy (CIDP) in China. This marks the first and only approved CIDP treatment in China, administered as a weekly 30-90 second subcutaneous injection. The approval is based on the ADHERE study, where Chinese participants showed a 69% reduction in relapse risk compared to placebo, with 78% demonstrating clinical improvement. The treatment addresses approximately 50,000 diagnosed CIDP patients in China, offering a new option beyond traditional corticosteroids and plasma-derived therapies.

Zai Lab (NASDAQ: ZLAB) announced positive topline results from its Phase 3 trial of KarXT for schizophrenia treatment in China. The trial met its primary endpoint, showing a significant 9.2-point reduction in PANSS Total score versus placebo at Week 5. The study also achieved all secondary endpoints, demonstrating improvements in positive and negative symptoms. Key results include a 1.9-point reduction in PANSS positive subscale and 2.5-point reduction in negative subscale versus placebo. The safety profile was consistent with previous trials. Based on these results, Zai Lab plans to submit a New Drug Application to China's NMPA in early 2025.