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Zai Lab Limited (NASDAQ: ZLAB) is a pioneering biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative medicines. Established in 2013 by industry veterans, Zai Lab addresses some of the world's most pressing unmet medical needs with a vision to transform patients’ lives globally.
The company employs a dual approach of in-licensing products and internal research and development to maintain a robust pipeline. This strategy has led to the development of promising drug candidates aimed at treating a range of severe health conditions, particularly in oncology, autoimmune, and infectious diseases.
Core Products and Pipeline:
- ZL-2306: An investigational treatment for multiple solid tumor types, including ovarian, breast, and lung cancers.
- ZL-2401: A novel antibiotic belonging to a new class of tetracycline derivatives, significant in the battle against resistant bacterial infections.
- ZL-2301: An oral small molecule targeting hepatocellular carcinoma (HCC), promising for liver cancer treatment.
Zai Lab's leadership team is acclaimed for their innovative regulatory approval pathways in China, which have expedited the introduction of new therapies. The company's partnerships with global pharmaceutical giants underscore its commitment to conducting world-class clinical development both in China and internationally.
Financially, Zai Lab has strong support from a cadre of leading healthcare investors, ensuring robust backing for its ambitious projects. This financial stability allows the company to explore cutting-edge research and expand its therapeutic offerings continually.
Recent Achievements and Current Projects:
- Successful initiation of multiple late-stage clinical trials across various therapeutic areas.
- Establishment of strategic partnerships with multinational pharmaceutical companies to enhance drug development and commercialization.
- Ongoing expansion of their research facilities to accommodate new projects and collaborations.
Zai Lab remains committed to leveraging its expertise, innovation, and strategic partnerships to bring life-changing therapies to market, ultimately improving patient outcomes worldwide.
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.
Zai Lab presented promising Phase 1a/1b study results for ZL-1310, a next-generation antibody-drug conjugate (ADC), in treating extensive-stage Small Cell Lung Cancer. The study showed a 74% objective response rate across all dose levels in previously treated patients. Key findings include positive responses in patients with brain metastases and favorable safety profile with mainly Grade 1 or 2 adverse events. Of 25 patients treated, only 20% experienced Grade ≥3 treatment-related adverse events, with neutropenia being most common. The drug demonstrated efficacy across various DLL3 expression levels, with 13 of 14 responders still on treatment.
Zai Lab (NASDAQ: ZLAB; HKEX: 9688) has announced its participation in three upcoming investor conferences. The company's senior management team will attend the Goldman Sachs APAC Healthcare Corporate Day 2024 in Hong Kong from November 5-8, 2024. They will also participate in the Jefferies London Healthcare Conference, featuring a fireside chat on Tuesday, November 19, 2024, at 1:30 p.m. GT in Aldwych, London. Lastly, Zai Lab will be present at Citi's 2024 Global Healthcare Conference in Miami, Florida, from December 3-5, 2024.
Zai Lab (NASDAQ: ZLAB; HKEX: 9688) has announced an upcoming investor webcast to discuss data from a Phase 1 clinical trial of ZL-1310, their investigational DLL3-targeted antibody-drug conjugate (ADC) for patients with advanced stage small cell lung cancer (SCLC). The live conference call and webcast is scheduled for October 24, 2024, at 8:30 a.m. ET (8:30 p.m. HKT), following a plenary oral presentation at the EORTC-NCI-AACR Symposium (ENA) 2024.
Interested parties can access the live webcast through Zai Lab's website at http://ir.zailaboratory.com. Participants must register in advance using the provided link: https://register.vevent.com/register/BI6f8ba8dc42d04cd3afd7095cf7c83d40. Upon registration, dial-in details will be sent via confirmation email. A replay of the webcast will be available on the company's website shortly after the call.
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