A blockbuster anti-infective drug with global sales of $400 million! Nanjing Zhengda Tianqing secures the first generic approval...

Letermovir tablets were originally developed by Merck & Co., which acquired them from AiCuris via a subsidiary. As the world’s first drug approved for this patient population, its tablet and intravenous formulations received FDA approval in 2017 under the brand name Prevymis. It is primarily indicated for the prevention of cytomegalovirus (CMV) infection and CMV disease in adult recipients who are CMV-seropositive [R+] and undergoing allogeneic hematopoietic stem cell transplantation (HSCT). A blockbuster antiviral drug with global sales of $400 million—significant market potential According to data from PharmCube, Merck’s letermovir has demonstrated robust growth in recent years: its global sales exceeded $165 million in 2019 and approached $400 million in 2021. In China’s hospital-based market, letermovir tablets have also performed impressively: hospital sales reached over RMB 2 million in 2022, surging to more than RMB 50 million in 2023—a staggering year-on-year growth of 2201.89%. In 2023, letermovir tablets and injection were included in the "National Basic Medical Insurance, Work-related Injury Insurance, and Maternity Insurance Drug Catalog (2022 Edition)." Currently, the retail price per box of letermovir tablets (240 mg × 28 tablets/box) remains above RMB 4,000—indicating substantial market potential. Twelve products achieving first-in-China generic equivalence evaluations made headlines; one new first-generic approval was recently secured.

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On April 18, Autobio Diagnostics announced that its net profit for Q1 2024 amounted to RMB 324 million, representing a 33.93% increase year-on-year. Products: 1. Afnabio: IND application accepted for RSV mRNA vaccine On April 16, Hefei Afnabio Biopharma’s respiratory syncytial virus (RSV) mRNA vaccine clinical trial application was accepted by the National Medical Products Administration (NMPA). Previously, Sinovac’s intranasal RSV vaccine (PIV5 vector), Shenxin Biotech’s RSV mRNA vaccine, and Maikokang Biotech’s recombinant RSV vaccine had also received IND acceptances. 2. CR Double-Crane: Semaglutide Injection approved for clinical trials On April 15, CR Double-Crane announced receipt of the NMPA’s “Clinical Trial Approval Notice” for its semaglutide injection. 3. A $600-million antiviral drug: Nanjing Zhengda Tianqing secures first generic approval On April 15, the official website of the National Medical Products Administration revealed that Nanjing Zhengda Tianqing Pharmaceutical’s letermovir tablets—filed as a Class 4 generic—had been approved for marketing, deemed to have passed consistency evaluation. This marks the first generic approval of letermovir in China. Letermovir is a novel antiviral agent with a unique anti-CMV mechanism: it inhibits the activity of the CMV terminase complex (pUL51, pUL56, and pUL89), thereby blocking viral DNA processing and packaging to exert antiviral effects. It is primarily indicated for the prevention of CMV infection and CMV disease in adult recipients who are CMV-seropositive [R+] and undergoing allogeneic hematopoietic stem cell transplantation (HSCT). In 2023, both letermovir tablets and injection were included in the National Medical Insurance Drug List (Class B) through the national negotiation process. Merck’s latest financial report shows that letermovir achieved global sales of $605 million in 2023, representing a 41.4% year-on-year increase. 4. Potential first-in-class! Eli Lilly’s tirzepatide succeeds in Phase III trial for obstructive sleep apnea On April 17, Eli Lilly announced positive results from the Phase III SURMOUNT-OSA clinical trial evaluating tirzepatide—a dual GLP-1R/GIPR agonist—for treating moderate-to-severe obstructive sleep apnea (OSA) in patients with obesity. Compared with placebo, tirzepatide injections (10 mg or 15 mg) significantly reduced the apnea-hypopnea index (AHI) in participants—the primary endpoint. AHI measures the number of breathing interruptions or complete airflow obstructions per hour of sleep and serves as a key metric for assessing OSA severity and treatment efficacy. Tirzepatide is currently the only GLP-1R/GIPR dual agonist approved for chronic weight management. It is commercialized in the U.S. under the brand name Zepbound and in select international markets under the brand name Mounjaro. This successful Phase III outcome for OSA opens a new therapeutic indication beyond weight management. 5. Vertex: Submits rolling NDA for NaV 1.8 inhibitor On April 18, Vertex announced the latest progress on VX-548, its selective NaV 1.8 inhibitor.

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