According to the official website of CDE, SCTV02 injection, a Class 1.2 new drug for preventive biological use developed by Sinocell Engineering Co., Ltd. (hereinafter referred to as "Sinocell"), has obtained implicit approval for clinical trials. Its indication is to prevent diseases caused by respiratory syncytial virus (RSV) infection.

Respiratory syncytial virus (RSV) is an infectious virus belonging to the genus Pneumovirus of the family Paramyxoviridae. It mainly causes lower respiratory tract infections such as bronchiolitis and pneumonia in infants under 6 months old, and upper respiratory tract infections such as rhinitis and colds in older children and adults. According to statistics, almost all children have been infected with respiratory syncytial virus before the age of 2. Due to the large population base in China, the number of children with lower respiratory tract infections caused by RSV infection ranks relatively high in the world.

RSV has always been called the R&D black hole in the vaccine industry, and its related R&D projects have often ended in failure. At present, there is no specific antiviral treatment for RSV in the world, but a number of RSV vaccines have been approved for marketing, and the dawn of the R&D black hole has begun to appear. In China, dozens of RSV vaccines have entered clinical trials and are currently being accelerated. According to the Pharmaceutical Economic News, RSV product sales are expected to grow at a compound annual growth rate of 31.65% from 2024 to 2030, and its sales may reach US$13.59 billion by then.

SCTV02 injection is a recombinant protein vaccine independently developed by Sinocell for the prevention of respiratory diseases caused by RSV infection with the goal of differentiated competitive advantage. Its clinical trial application was accepted by CDE in July 2024. According to the Sinocell announcement, the product was approved for clinical trials in healthy people aged ≥18 years to prevent respiratory diseases caused by respiratory syncytial virus (RSV) infection.

Sinocell focuses on the development of innovative biological drugs and vaccines, and has built a comprehensive and rich pipeline of research products covering various indications such as tumors and autoimmune diseases.
Recently, new progress has been made in the research of multiple products of Sinocell.

SCTV04C is a recombinant protein vaccine independently developed by Sinocell. In September, it was approved by CDE to conduct clinical trials for the prevention of herpes zoster and complications caused by varicella-zoster virus (VZV) infection. Herpes zoster is an infectious skin disease caused by the reactivation of latent VZV. The number of patients in China has increased year by year and is showing a trend of younger age. According to Frost & Sullivan's forecast, the market size of herpes zoster vaccine in China may reach 5.63 billion yuan in 2025, with a compound annual growth rate of 16.4%.

SCT520FF is an anti-angiogenic biological drug. In September, it obtained implicit approval for clinical trials from CDE. The indication is neovascular age-related macular degeneration (nAMD). According to statistics, the prevalence of nAMD in the global population aged 45-85 is about 8.7%; according to Evaluate Pharma's forecast, the market for nAMD treatment may grow to US$8.471 billion in 2024.

SCTB41 is a trispecific antibody injection that was approved in August for clinical trials in patients with advanced malignant solid tumors. On September 10, Sinocell registered a clinical study on the Drug Clinical Trial Registration and Information Disclosure Platform: an open, multicenter, dose-escalation and dose-expansion Phase I/II clinical trial to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of SCTB41 for the treatment of patients with advanced malignant solid tumors. Currently, the study is recruiting patients. In addition, there

are a number of products in the Sinocell pipeline, including recombinant anti-IL-17 monoclonal antibodies, anti-CD38 monoclonal antibodies, CD20/CD3 bispecific antibodies, etc., which are accelerating clinical research.

In the 2024 semi-annual report, Sinocell stated that it has mastered the process development and large-scale production technology of comprehensive recombinant proteins, monoclonal antibodies, and innovative vaccines, and all proprietary technologies, patents, and biopharmaceutical candidate varieties are independently developed. By accelerating the research of new drug pipelines, Sinocell is expected to reap more innovative fruits.

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