Pipeline

BAT2406 (dupilumab injection) is a fully human monoclonal antibody (IgG4 type) that inhibits IL-4 and IL-13 signaling by specifically binding to the IL-4Rα subunit shared by the interleukin-4 (IL-4) and interleukin-13 (IL-13) receptor complexes. Dupilumab inhibits IL-4 signaling through type I receptors and inhibits IL-4 and IL-13 signaling through type II receptors. Phase I BE trial (China); Potential indications: atopic dermatitis, asthma, prurigo nodularis, chronic sinusitis with nasal polyps, eosinophilic esophagitis, chronic obstructive pulmonary disease; BAT2406 (recombinant fully human anti-IL-4Rα monoclonal antibody) is a biosimilar of dupilumab (Dupixent®). Currently, a comparative study exploring the pharmacokinetics and safety of BAT2406 and dupilumab (Dupixent®) in healthy male subjects in China is progressing.

Mepolizumab (anti-IL-5 monoclonal antibody) can be used to treat diseases such as eosinophilic granulomatosis with polyangiitis and eosinophilic severe asthma in adults. BAT2606 is a biosimilar of mepolizumab and has completed a Phase I pharmacokinetics (PK) similarity clinical study in China. The results show that the PK characteristics, safety and immunogenicity of BAT2606 and the original drug mepolizumab are similar.

BAT4406F is a fully human monoclonal antibody of the IgG1 subclass with enhanced ADCC effect. BAT4406F can target and bind to CD20 on the surface of B cells and precursor cells. In the presence of complement, NK natural killer cells, phagocytes, etc., it can eliminate B cells in patients through mechanisms such as ADCC and CDC to treat and alleviate the disease. BAT4406F is being developed for the treatment of neuromyelitis optica spectrum disorder NMOSD and/or nephrotic syndrome (minimal change disease MCD/focal segmental glomerulosclerosis FSGS). Currently, the marketing authorization application for BAT4406F has been accepted by NMPA.

BAT6026 is an afucosylated fully human anti-OX40 monoclonal antibody developed by Bio-Thera and is intended to be used to treat advanced malignant solid tumors and atopic dermatitis. OX40 is an activating immune checkpoint expressed on activated immune cells (mainly CD4+ and CD8+ T cells and intra-tumor Treg cells). OX40L is the only known ligand of OX40 and is expressed on activated APC cells. When OX40 is activated by OX40L, its downstream signaling pathways promote T cell division, survival, and cytokine production. At the sites of inflammatory diseases such as atopic dermatitis, the ligand OX40L promotes the activation of helper T cells such as Th2 by activating the OX40 signaling pathway, thereby promoting the occurrence of inflammation. BAT6026 not only blocks the OX40/OX40L signaling pathway to inhibit T cell activation and proliferation, but also depletes activated OX40+ T cells through enhanced ADCC effect. Therefore, BAT6026 is expected to improve diseases caused by excessive activation of Th2 cells. Currently, the national multi-center Phase Ib/IIa clinical study of BAT6026 for atopic dermatitis (AD) is underway.

secukinumab (anti-IL-17A monoclonal antibody) can be used to treat plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, hidradenitis suppurativa and other diseases. BAT2306 secukinumab biosimilar completed Phase III international multi-center clinical studies in China, Hungary, Poland, and Japan. The results showed that BAT2306 has similar efficacy, safety, pharmacokinetics and immunogenicity to the original drug. Currently, BAT2306 has submitted a marketing application to the NMPA.

ustekinumab (a fully human monoclonal antibody targeting the p40 subunit shared by interleukins IL-12 and IL-23) can be used to treat moderate to severe plaque psoriasis, active psoriatic arthritis, moderate to severe Crohn's disease, and moderate to severe active ulcerative colitis. BAT2206 ustekinumab biosimilar has completed phase III international multi-center clinical studies in China, Bulgaria, Poland, Russia and Georgia. ustekinumabBAT2206 (US trade name: STARJEMZA®, European trade name: Usymro®) has been approved in Europe and the United States.

Golimumab (TNF-α antagonist) can be used to treat rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, ulcerative colitis and other diseases. BAT2506 is a biosimilar of golimumab (trade name: Simponi®) and has completed Phase III international multi-center clinical studies in China, Poland, the Czech Republic, Bulgaria, and Ukraine. The research results show that BAT2506 has similar efficacy, safety, pharmacokinetics and immunogenicity to the original drug. At present, Gotenfia® has been approved in Europe, and the marketing authorization application for BAT2506 has been accepted by China's NMPA and the US FDA.

Shiruili® (tocilizumab) (US trade name: Shiruili) is tocilizumab injection independently developed by Bio-Thera in accordance with the relevant guidelines of China NMPA, US FDA, and European EMA biosimilars. It is a recombinant humanized monoclonal antibody targeting the interleukin-6 receptor (IL-6R). It can specifically bind to soluble and membrane-bound IL-6 receptors (sIL-6R and mIL-6R) and inhibit sIL-6R and mIL-6R-mediated signaling. TOFIDENCE® (US trade name: TOFIDENCE) is the first tocilizumab biosimilar approved by China's NMPA and the US FDA. The approved indications in China are rheumatoid arthritis (RA), systemic juvenile idiopathic arthritis (sJIA), and cytokine release syndrome (CRS). The approved indications in the United States are moderate to severe rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (pJIA), and systemic juvenile idiopathic arthritis (sJIA).

The company's independently developed BAT1406 "Geleli" is a recombinant fully human monoclonal antibody expressed in CHO cells. It is the first adalimumab biosimilar to receive marketing approval in China. Geleli blocks the inflammatory effect of TNF-α by specifically binding to TNF-α and neutralizing its biological function, blocking its interaction with TNF-α receptors on the cell surface. Geleli has been approved for eight indications in China, including five adult indications: psoriasis, ankylosing spondylitis, rheumatoid arthritis, Crohn's disease and uveitis, and three pediatric indications: children's plaque psoriasis, polyarticular juvenile idiopathic arthritis, and children's Crohn's disease. Available in 40mg/0.8ml and 20mg/0.4ml dual specifications.

BAT8013 is a CD25-targeting antibody drug conjugate (ADC) developed by Bio-Thera and is intended to be developed for the treatment of advanced or metastatic solid tumors. BAT8013 specifically binds to CD25 on the cell surface and enters the cell via receptor-mediated endocytosis. In the lysosomal environment, its linker is cleaved by cathepsin, releasing the cytotoxic payload Exatecan. Exatecan, as a topoisomerase I inhibitor, can cause DNA single-strand breaks to accumulate and convert into double-strand breaks during replication, thereby triggering cell apoptosis. This mechanism can not only selectively eliminate regulatory T cells (Tregs) in the tumor microenvironment, improve the tumor immunosuppressive microenvironment, but also directly kill CD25⁺ tumor cells.

BAT7111 is a PD-1/4-1BB bispecific antibody developed by Bio-Thera. By simultaneously blocking the PD-1/PD-L1 immunosuppressive pathway and conditionally activating the 4-1BB costimulatory signal, BAT7111 achieves dual mechanism synergy and is expected to become an important breakthrough in the field of tumor immunotherapy. Currently, phase I/II clinical trials of BAT7111 in patients with advanced solid tumors are ongoing.

BAT3306 is a biosimilar of pembrolizumab (Keytruda®) developed by the company. Pembrolizumab is a humanized monoclonal antibody drug that is an immune checkpoint inhibitor. It can specifically bind to the PD-1 receptor located on lymphocytes, and by blocking the binding of PD-1 to its ligands PD-L1 and PD-L2, it can relieve the immune suppression of T cells by tumors and reactivate the immune response of T cells to tumor cells, thereby achieving therapeutic effects on various types of cancer. BAT3306 is a biosimilar of Keytruda under development. Currently, a phase I clinical trial of adjuvant therapy for postoperative patients with non-small cell lung cancer is ongoing.

BAT7205 is a PD-L1/IL-15 bifunctional antibody fusion protein developed by Bio-Thera and is intended to be developed for the treatment of locally advanced or metastatic solid tumors. BAT7205 is composed of recombinant humanized anti-PD-L1 antibody and IL-15/IL-15Rαsushi fusion protein. It can not only block the PD-1/PD-L1 immunosuppressive pathway, but also activate immune cells through IL-15, thereby achieving a synergistic effect of releasing immunosuppression and activating immunity against tumors. In addition, PD-L1 antibodies can target IL-15 to the PD-L1+ tumor microenvironment and selectively activate tumor-infiltrating CD8+ T cells and NK cells, which can reduce the systemic side effects of IL-15; fusion with PD-L1 antibodies can also significantly extend the half-life of IL-15 in the body, giving it a more durable biological function. Currently, a Phase I clinical trial of BAT7205 in patients with advanced solid tumors is ongoing.

BAT8008 is intended to be developed for the treatment of solid tumors. Trop2 (Trophoblast cell-surface antigens 2), also known as TACSTD2, M1S1, GA733-1, and EGP-1, is a member of the tumor-associated calcium signal transducer (TACSTD) gene family and is related to the regulation of intracellular calcium ion concentration. BAT8008 is composed of a recombinant humanized anti-Trop2 antibody and a toxic small molecule topoisomerase I inhibitor connected through the company's independently developed cleavable linker. Currently, the Phase I clinical study of BAT8008 in patients with advanced solid tumors is underway. The ORR and mPFS data of BAT8008 for breast cancer, non-small cell lung cancer, cervical cancer and esophageal cancer are at a better level than similar drugs and have a tolerable safety profile. It plans to prioritize phase III clinical studies in cervical cancer and breast cancer.
8008+1308: Phase Ib/II clinical trial (China), BAT8008 (anti-Trop-2 ADC monoclonal antibody) combined with BAT1308 (anti-PD-1 monoclonal antibody) is being investigated for the treatment of non-small cell lung cancer (NSCLC) and triple-negative breast cancer (TNBC). At present, the phase Ib/II clinical trial exploring the indications of BAT8008 combined with BAT1308 in second-line and above second-line non-small cell lung cancer and triple-negative breast cancer has completed enrollment, and the phase II clinical trial in the indication of first-line non-small cell lung cancer and first-line triple-negative breast cancer is in progress.
8008+1308+4706: Phase II clinical trial (China), BAT8008 (anti-Trop-2 ADC monoclonal antibody) combined with BAT1308 (anti-PD-1 monoclonal antibody) and BAT4706 (anti-CTLA-4 monoclonal antibody) is being investigated for the treatment of non-small cell lung cancer (NSCLC). Currently, phase II clinical trials exploring the indications of BAT8008 combined with BAT1308 and BAT4706 as a three-drug combination in second-line and above second-line non-small cell lung cancer are in progress.
BAT8008+7104: BAT8008 (anti-Trop2 ADC) combined with BAT7104 (anti-PD-L1/CD47 bispecific antibody) is being investigated for the treatment of solid tumors. A Phase Ib-II clinical trial of BAT8008 combined with BAT7104/bevacizumab for advanced solid tumor indications has completed preliminary dose and efficacy exploration.

BAT4706 is a fully human anti-CTLA-4 (cytotoxic T lymphocyte antigen 4) monoclonal antibody independently developed by Bio-Thera and optimized by afucosylation. It belongs to the IgG1 subtype and is expressed by Chinese hamster ovary cells. CTLA-4 is mainly expressed by regulatory T cells (Tregs) and activated CD4+, CD8+ positive T lymphocytes, and is a suppressive immune checkpoint. CD80 and CD86 are two ligands of CTLA-4. When CD80 or CD86 binds to CTLA-4, it can inhibit the immune activation of T cells through downstream signaling pathways. BAT4706 can bind to CTLA-4 on T cells with high affinity, block the interaction between CTLA-4 and its ligand CD80 or CD86, restore the binding of CD80 or CD86 to CD28, and relieve the inhibitory effect of the CTLA-4 pathway on T cells, thereby restoring the immune killing function of T cells. At the same time, the afucosylation optimization of BAT4706 enables the antibody to have enhanced antibody-dependent cytotoxicity (ADCC), which can lead to the apoptosis of Tregs in the tumor microenvironment, thereby further improving the body's immune response to cancer and inhibiting tumor growth. Currently, the Phase I clinical trial exploring the indication of BAT4706 in advanced solid tumors has been completed.
8008+1308+4706: Phase II clinical trial (China), BAT8008 (anti-Trop-2 ADC monoclonal antibody) combined with BAT1308 (anti-PD-1 monoclonal antibody) and BAT4706 (anti-CTLA-4 monoclonal antibody) is being investigated for the treatment of non-small cell lung cancer (NSCLC). Currently, phase II clinical trials exploring the indications of BAT8008 combined with BAT1308 and BAT4706 as a three-drug combination in second-line and above second-line non-small cell lung cancer are in progress.
BAT4706+1308: Phase I clinical trial (China). Currently, the Phase I clinical trial exploring BAT4706 combined with BAT1308 for indications in advanced solid tumors is ongoing.

BAT1006 is a monoclonal antibody targeting HER2. It can bind to the extracellular domain II of HER2, block the heterodimerization of HER2 and other HER family receptors (EGFR/HER3/HER4), inhibit the proliferation and survival of tumor cells mediated by HER2 receptors, and is intended to be used to treat HER2-positive locally advanced or metastatic solid tumors. BAT1006 is an ADCC-enhanced monoclonal antibody that has a stronger ability to recruit killer cells such as NK and has a stronger killing effect on tumor cells. Currently, the Phase I clinical trial exploring BAT1006 in the treatment of HER2-positive locally advanced or metastatic breast cancer has ended, and a Phase II/III study of BAT1006 combined with trastuzumab and chemotherapy in breast cancer is currently underway.

1006 +8010: The phase Ib/lla multi-center clinical study of BAT8010 combined with BAT1006 for HER2-positive (IHC3+ or FISH+) first-line breast cancer and HER-2-expressing post-first-line gastric cancer indications is ongoing.

BAT7104 is a bispecific antibody that specifically blocks the interaction of human PD-L1 and CD47 with their corresponding receptors and is being developed for solid tumors. The Phase Ia/Ib clinical study of BAT7104 injection in patients with advanced malignant tumors in China and the Phase I clinical study in patients with advanced malignant tumors in Australia have been completed.
BAT8008+7104: BAT8008 (anti-Trop2 ADC) combined with BAT7104 (anti-PD-L1/CD47 bispecific antibody) is being investigated for the treatment of solid tumors. A Phase Ib-II clinical trial of BAT8008 combined with BAT7104/bevacizumab for advanced solid tumor indications has completed preliminary dose and efficacy exploration.

BAT8006 is an antibody drug conjugate (ADC) targeting folate receptor α (FRα) developed by Bio-Thera and is intended to be developed for the treatment of solid tumors. FRα is a folate-binding protein located on the cell membrane and is overexpressed in a variety of solid tumors such as ovarian cancer, lung cancer, endometrial cancer, and breast cancer. The distribution of FRα in normal human tissues is limited to the apical surfaces of kidneys, lungs, choroidal plexus and other organs, and the expression level is low. BAT8006 is composed of a recombinant humanized anti-FRα antibody and a toxic small molecule topoisomerase I inhibitor, connected through a self-developed cleavable linker. BAT8006 has high anti-tumor activity. The toxin small molecule has strong cell membrane penetration ability. After the ADC kills the cancer cells, it can be released and kill nearby cancer cells, producing a bystander effect and effectively overcoming the heterogeneity of tumor cells. At the same time, BAT8006 has good stability and safety, and the release of small toxin molecules in plasma is extremely low, reducing the risk of off-target toxicity. Early clinical data of BAT8006 show that among 133 patients with platinum-resistant ovarian cancer enrolled in dose exploration and expansion studies (regardless of FRα expression level and number of previous lines), the median PFS reached 7.63 months, the ORR was 40.7%, and the DCR was 80.5%. No interstitial pneumonia and ocular toxicity were found, showing significant efficacy and good safety, and demonstrating excellent clinical application potential. The pivotal registration phase III clinical trial of BAT8006 for the treatment of platinum-resistant high-grade serous epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer is currently underway.
8006+1706: The phase II/III clinical study of 8006+1706-001-CR for the maintenance treatment of platinum-sensitive recurrent ovarian cancer is ongoing in China.
8006+1308: A Phase I/II clinical study of BAT8006 in combination with BAT1308 is evaluating safety and efficacy in patients with endometrial cancer that has progressed after platinum-containing chemotherapy or immunotherapy.

BAT8010 is intended to be developed for the treatment of solid tumors. HER2 is a member of the epidermal growth factor receptor family (EGFR). It is highly expressed in a variety of solid tumors, plays an important role in tumor proliferation, invasion and metastasis, and is associated with poor prognosis of tumors. HER2 expression levels are low in normal human tissues. BAT8010 is composed of a recombinant humanized anti-HER2 antibody and a toxic small molecule topoisomerase I inhibitor, connected through the company's independently developed cleavable linker. Currently, a Phase I clinical trial exploring the indication of BAT8010 in advanced solid tumors has been completed.

1006 +8010: The phase Ib/lla multi-center clinical study of BAT8010 combined with BAT1006 for HER2-positive (IHC3+ or FISH+) first-line breast cancer and HER-2-expressing post-first-line gastric cancer indications is ongoing.

BAT1308 is a humanized anti-PD-1 monoclonal antibody independently developed by Bio-Thera. It belongs to the IgG4κ subtype and is expressed by Chinese hamster ovary cells. PD-1 is mainly expressed by activated T lymphocytes and is a suppressive immune checkpoint. PD-L1 and PD-L2 are two ligands of PD-1. When PD-L1 or PD-L2 binds to PD-1, it can inhibit the immune activation of T cells through downstream signaling pathways. BAT1308 can bind to PD-1 on T cells with high affinity, block the interaction between PD-1 and its ligands, and relieve the inhibitory effect of the PD-1 pathway on T cells, thereby restoring the immune killing function of T cells and inhibiting tumor growth.
8008+1308: Phase Ib/II clinical trial (China), BAT8008 (anti-Trop-2 ADC monoclonal antibody) combined with BAT1308 (anti-PD-1 monoclonal antibody) is being investigated for the treatment of non-small cell lung cancer (NSCLC) and triple-negative breast cancer (TNBC). At present, the phase Ib/II clinical trial exploring the indications of BAT8008 combined with BAT1308 in second-line and above second-line non-small cell lung cancer and triple-negative breast cancer has completed enrollment, and the phase II clinical trial in the indication of first-line non-small cell lung cancer and first-line triple-negative breast cancer is in progress.
8008+1308+4706: Phase II clinical trial (China), BAT8008 (anti-Trop-2 ADC monoclonal antibody) combined with BAT1308 (anti-PD-1 monoclonal antibody) and BAT4706 (anti-CTLA-4 monoclonal antibody) is being investigated for the treatment of non-small cell lung cancer (NSCLC). Currently, phase II clinical trials exploring the indications of BAT8008 combined with BAT1308 and BAT4706 as a three-drug combination in second-line and above second-line non-small cell lung cancer are in progress.
8006+1308: A Phase I/II clinical study of BAT8006 in combination with BAT1308 is evaluating safety and efficacy in patients with endometrial cancer that has progressed after platinum-containing chemotherapy or immunotherapy.
BAT1308 combined with platinum-based chemotherapy ± bevacizumab is being investigated for the first-line treatment of PD-L1-positive (CPS ≥ 1) persistent, recurrent or metastatic cervical cancer. At present, the Chinese phase II clinical study exploring the BAT1308 combination regimen for cervical cancer indications has completed enrollment, with an objective response rate of 74.1% and a disease control rate of 100%. Phase III clinical research for cervical cancer indications in China is progressing.
BAT4706+1308: Phase I clinical trial (China). Currently, a Phase I clinical trial exploring BAT4706 combined with BAT1308 for indications in advanced solid tumors is ongoing.

BAT4306F (anti-CD20 antibody) is a glycosyl-optimized ADCC-enhanced anti-CD20 antibody. The first indication currently being developed is relapsed/refractory CD20-positive B-cell non-Hodgkin lymphoma.

Pubeixi® is a recombinant humanized IgG1 monoclonal antibody developed by Bio-Thera. It is a vascular endothelial growth factor (VEGF) inhibitor. It binds to vascular endothelial growth factor (VEGF) and inhibits the binding of VEGF to its receptor, thereby blocking the angiogenesis signal transduction pathway and inhibiting the growth of tumor cells. In China, Pubeixi® has been approved for advanced, metastatic or recurrent non-small cell lung cancer; metastatic colorectal cancer; recurrent glioblastoma
; epithelial ovarian, fallopian tube or primary peritoneal cancer; and cervical cancer.

8006+1706: The phase II/III clinical study of 8006+1706-001-CR for the maintenance treatment of platinum-sensitive recurrent ovarian cancer is ongoing in China.

Beitaning® (BAT2094, bevifibatide citrate injection) is a Class 1 chemical drug independently developed by Bio-Thera and has independent intellectual property rights. It is a peptide β3 integrin receptor inhibitor. The platelet glycoprotein receptor αIIbβ3 (also known as IIb/IIIa) receptor is a platelet surface receptor that plays a leading role in the platelet aggregation process. Bevifibatide citrate prevents fibrinogen, Von Willebrand factor and other adhesion ligands from binding to glycoprotein receptor αIIbβ3, thereby blocking platelet cross-linking and platelet aggregation. At the same time, bevifibatide citrate can also inhibit the integrin receptor αvβ3 related to the proliferation of blood vessel wall cells, thereby inhibiting the growth of vascular smooth muscle and reducing the risk of arterial blood vessel re-occlusion.

BAT5906 (recombinant anti-VEGF humanized monoclonal antibody injection) is being developed for the treatment of AMD/DME/CRVO/pmCNV. Currently, the marketing authorization application for BAT5906 (AMD) has been accepted by the NMPA. Phase III clinical studies for DME/CRVO/pmCNV are ongoing.