China-based Clover Biopharmaceuticals, Ltd (HKG: 2197) has provided updates on its plans for the commercialization of its COVID-19 vaccine SCB-2019 (CpG 1018/Alum) in China, with a strategic focus on 2023. The company expects to begin the commercial launch of SCB-2019 in multiple provinces and municipalities in China during the first quarter of 2023.
Market Opportunity and Regulatory Progress
Given the ongoing COVID-19 outbreaks in China, Clover anticipates a significant long-term market opportunity for its premium and broadly protective COVID-19 vaccine. SCB-2019 was granted emergency use authorization (EUA) in China in early December 2022. Clover expects to secure additional EUAs in at least one more country and complete multiple EUA submissions during the first half of 2023. These efforts could drive revenue through bilateral deals starting in 2023.
Manufacturing and Production Capacity
Clover’s GMP-certified plant facilities are poised to meet the demand for SCB-2019 across multiple markets. The company has stockpiled key raw materials, enabling it to produce and release over 100 million doses of SCB-2019 in 2023. Clover is also developing a multivalent SARS-CoV-2 vaccine using its Trimer-Tag technology platform and is advancing SCB-2020S, a second-generation COVID-19 vaccine candidate with broad protective potential.
Pipeline Expansion and Strategic Focus
Clover plans to expand its mid- to late-stage pipeline (Phase 2, Phase 3, and Commercial) beginning in the first half of 2023. The company aims to build a leading respiratory vaccine franchise and establish a presence in the pediatric vaccine market in China and the Asia-Pacific region. Clover expects to announce at least one mid- to late-stage vaccine in-licensing deal in the first half of 2023. Prioritized areas include respiratory syncytial virus (RSV), seasonal influenza, enterovirus A71 (EV71), and DTaP (diphtheria, tetanus, and pertussis).
Financial Position and Future Outlook
As of December 31, 2022, Clover’s unaudited cash and cash equivalents stood at approximately USD 270 million (RMB 1.9 billion), positioning the company for success beyond 2023. Clover expects R&D and other costs to decrease significantly in 2023 compared to previous years, as the late-stage clinical development for SCB-2019 has been largely completed. The company continues to streamline operations to enhance efficiency and drive growth.-Fineline Info & Tech
