Our Pipeline
Our diverse pipeline is designed to meaningfully reduce the burden of vaccine-preventable diseases—and to make more diseases preventable.
Our diverse pipeline is designed to meaningfully reduce the burden of vaccine-preventable diseases—and to make more diseases preventable.
| Product Candidate | Target | Indication | Discovery | Preclinical | IND/CTA | Phase 1 | Phase 2 | Phase 3 | Filing | Approval/ EUA |
| SCB-2019 (CpG 1018/Alum)(1) | SARS-CoV-2 S-Trimer (Broad Neutralization) |
COVID-19 Universal Booster |
China Global (Ex-China) |
|||||||
| AdimFlu-S (QIS)(2) | Influenza A and B |
Seasonal Influenza | China | |||||||
| ≥ 1 Mid-to-Late Stage In-Licensed Vaccines(3) | - | Respiratory Virus Vaccines (Pneumococcal, etc.) Pediatric Vaccines (EV71, Combination Pediatric, etc.) |
Phase 2 / Phase 3 / Approved Assets |
|||||||
| Multivalent SARS-CoV-2 Vaccine(4) | SARS-CoV-2
S-Trimers (Multivalent) |
COVID-19 | ||||||||
| RSV Vaccine | RSV F-Trimer | Respiratory Syncytial Virus (RSV) | ||||||||
| SCB-1001(5) | Rabies G-Trimer | Rabies |
| Product Candidate | Target | Indication | Discovery | Preclinical | IND/CTA | Phase 1 | Phase 2 | Phase 3 | Filing | Approved/ EUA |
| SCB-219M(7) | TPO Mimetic Bispecific-Fc | Chemotherapy-Induced Thrombocytopenia (CIT) | ||||||||
| SCB-313(8) | TRAIL-Trimer | Intracavitary Malignancies {Malignant Ascites, Malignant Pleural Effusion, Peritoneal Carcinomatosis} |
(1) COVID-19 vaccine received EUA in China in December 2022; at least one global (ex-China) EUA expected in H1 2023.
(2) We entered into an exclusive agreement with Adimmune to commercialize AdimFlu-S in mainland China in February 2023.
(3) Additional mid- to late- stage in-licensing deal is planned in 2023 with a focus on respiratory virus and pediatric vaccines in China and Asia Pacific region.
(4) To be based on a multivalent S-Trimer vaccine; advancement to clinical development is planned in 2023.
(5) Additional preclinical results and update on development plans are expected in 2023.
(7) Interim Phase 1 data and recommended Phase 2 dose selection anticipated in 2023.
(8) Oncology product candidate for the treatment of malignant ascites (MA), malignant pleural effusions (MPE), and peritoneal carcinomatosis (PC) to address global unmet medical need of intracavitary malignancies. Five Phase 1 trials completed in China and Australia. Continued internal development of SCB-313 has been paused and pending further assessment of development strategy and resource allocation.
We developed the SCB-2019 antigen, a stabilized trimeric form of the S-protein based on the original strain of the SARS-CoV-2 virus, and combined it with Dynavax's CpG 1018 advanced adjuvant and aluminum hydroxide (alum). Phase 2/3 data from 30,000+ participants across five countries showed that SCB-2019 (CpG 1018/Alum) achieved 100% efficacy against severe COVID-19 and hospitalization caused by all strains of SARS-CoV-2 circulating during the trial, and a potentially best-in-field safety profile. To date, these trials have shown that SCB-2019 (CpG 1018/Alum) elicited a robust neutralization of variants including Omicron.
We have received emergency use authorization for SCB-2019 (CpG 1018/Alum) in China. In addition, we are pursuing regulatory submissions of SCB-2019 (CpG 1018/Alum) directly in select countries, primarily in Asia Pacific and Latin America.
AdimFlu-S (QIS) is a quadrivalent split inactivated vaccine intended for use in the prevention of influenza. As a quadrivalent vaccine, it contains hemagglutinin from four influenza virus strains (two A and two B), which increases its chances of achieving high vaccine effectiveness regardless of which influenza B strain becomes seasonally prevalent relative to trivalent options. AdimFlu-S (QIS) was approved by the China National Medical Products Administration in January 2022 for individuals aged three years and older.
We are conducting research to develop a multivalent SARS-CoV-2 vaccine designed to be broadly protective against all currently circulating and potential future strains of the virus. Clinical development is planned to begin in 2023, with Phase 3 immunological bridging to SCB-2019 (CpG 1018/Alum) planned to support potential regulatory approvals.
Our respiratory syncytial virus (RSV) vaccine candidate (Fusion F Antigen-Trimer) induced a strong neutralizing antibody response in a rat immunization model. This candidate demonstrated high binding affinity (sub-picomolar) to palivizumab. Additional preclinical results and an update on development plans for this candidate are expected soon.
We continue to conduct preclinical studies to develop our rabies vaccine candidate. Additional preclinical results and an update on development plans for this candidate are expected soon.
We are conducting a Phase 1 trial for SCB-219M, an innovative human thrombopoietin receptor agonist (TPO-RA), for the treatment of chemotherapy-induced thrombocytopenia. Phase 1 data is expected in H1 2023.
We developed SCB-313 as a covalently-linked, native-like trimeric fusion protein which is structurally and functionally differentiated from the dimeric antibody-based structures and other native ligand-based candidates targeting this pathway. We believe SCB-313 has the potential to address the unmet global need for the treatment of intracavitary malignancies, including malignant ascites, malignant pleural effusions and peritoneal carcinomatosis.
