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再鼎医药(9688.HK):艾加莫德全年收入指引上调至超过8000万美元 期待研发催化

Zaiding Pharmaceutical (9688.HK): Agamod's annual revenue guidance raised to more than 80 million US dollars in anticipation of R&D catalysts

西南證券 ·  Aug 12  · Researches

Incident: On August 7, Zaiding Pharmaceutical announced its 2024 interim results. Product revenue for the second quarter of 2024 was 0.1 billion US dollars, achieving product revenue exceeding 0.1 billion US dollars for the first time in a single quarter. The total amount of the company's cash and cash equivalents, short-term investments and restricted cash was 0.73 billion US dollars.

Agamod's annual revenue guidance was raised to over $80 million. The commercialization of Agamod continues to materialize. In the first quarter of 2024, Agamod's sales reached 13.2 million US dollars, the second quarter sales reached 23.2 million US dollars, and the annual revenue guide was raised to more than 80 million US dollars. In July 2024, agamod alpha subcutaneous injection was approved for marketing in adults with positive acetylcholine receptor antibodies for general systemic myasthenia gravis. In May 2024, the SBLA application for the treatment of CIDP was accepted by the NMPA and included in priority review.

The State Drug Administration approved the marketing of sulbactam sodium-dulobactan sodium in 2024. In May 2024, Zaiding Pharmaceutical and Innoviva Specialty Therapeutics announced that China's State Drug Administration has approved Dingyule? (Sulbactan sodium-dulobactan sodium, SUL-DUR) new drug marketing application for the treatment of hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by sensitive isolates of Baumann-Calcium Acetate Acinetobacter complex in patients aged 18 and above.

The company expects a number of significant milestones in the second half of 2024 and the first half of 2025. KarXT is expected to submit marketing licensing applications for second-line NSCLC and above in Q4 2024; Tisotumab Vedotin is expected to submit BLA for recurrent or metastatic cervical cancer; reptinib is expected to submit SNDA for NTRK positive solid tumors; and karXT is expected to submit an NDA for schizophrenia. Expected clinical data include that Zaiding Pharmaceutical will add Agamod prefilled subcutaneous injections for thyroid eye disease in Q4 in 2024, the efficacy of immune-mediated subtypes of myositis: necrotizing myopathy, anti-synthase syndrome, and dermatomyositis; and a global registered phase III study of seronegative GMG and ocular myasthenia gravis in early 2025. Data from the KarXT China Schizophrenia Registry Bridging Study is expected to be released by the end of 2024. Novocure is expected to release key data from phase III clinical studies of tumor electric field therapy for locally advanced pancreatic cancer in Q4 2024.

Profit forecast. As sales of products such as nirapalil, electric field therapy for tumors, remipitinib, omacycline toluenesulfonate, and agamod continue to rise, we expect the company's revenue for 2024-2026 to be US$3.8, 5.6, and US$82 billion, respectively.

Risk warning: R&D falls short of expectations, commercialization falls short of expectations, market competition increases risk, drug price reduction risk.

The translation is provided by third-party software.


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