In the biotechnology field, bispecific antibodies are becoming game-changing innovative therapeutics.
On June 17, 2025, the Hong Kong IPO application of Innovent Biologics, a pioneer in the next-generation bispecific antibodies, was accepted and the prospectus was officially released.
Founded in 2015, EpiMed Biopharma has been focused on developing bispecific antibodies using its proprietary bispecific antibody platform since its inception. Its strategic focus is on the field of T cell engagers, focusing on two major disease areas: tumors and autoimmune diseases.

EpiMed has developed a proprietary technology platform designed to overcome the limitations of traditional bispecific antibody development:

FIT-Ig platform: It has a unique linker-free, non-mutational and tetravalent bispecific antibody platform that can quickly generate bispecific antibody molecules while maintaining the biological function of each antibody domain, thereby achieving plug-and-play for multiple different targets. The FIT-Ig platform is the only bispecific antibody technology in the world that does not require any amino acid mutations, does not contain linker peptide chains or any non-antibody sequences.

MAT-Fab Platform: Complementing the FIT-Ig platform, this is a proprietary bivalent alternative format specifically tailored for specific targets such as ROR1, enabling the company to develop more optimized ROR1 T cell engagers.

T-FIT platform: Combining TCR specificity with EpiMed's proprietary CD3 antibody technology, TCR TCEs are generated that can recognize intracellular tumor-specific targets (such as KRAS mutations) presented by peptide-HLA complexes on cancer cells. It overcomes the key limitations of existing TCR-based therapies, such as high production difficulty, short in vivo half-life, and the need for extensive molecular engineering.

The prospectus shows that Innovent Biologics has established a pipeline consisting of 9 self-developed antibody therapies. In addition to the core pipeline EMB-01 (targeting EGFR/cMET), the other 8 are CD3 T cell engagers.

Specifically, in the field of oncology, Innovent Biologics already has three clinical-stage drug candidates, including the core product EMB-01 (targeting EGFR/cMET), two key products based on T cell engagers, EMB-06 (targeting BCMA/CD3) and EMB-07 (targeting ROR1/CD3), and three preclinical drug candidates based on T cell engagers, EM1032 (targeting ALPP(G)/CD3), EM1034 (targeting LY6G6D/CD3) and EM1031 (targeting KLK2/CD3).

In the field of immunology, Innovent Biologics already has a clinical-stage drug candidate, the key product EMB-06 based on T cell engagers, as well as two preclinical drug candidates based on T cell engagers, EM1039 and EM1042.

Core product EMB-01 (EGFR/cMET)

EMB-01 is a tetravalent bispecific antibody that simultaneously targets EGFR and cMET, and is expected to become one of the world's first bispecific antibodies targeting EGFR/cMET for colorectal cancer to be marketed.

In a Phase Ib/II study of patients with heavily treated metastatic colorectal cancer, EMB-01 showed good efficacy. As of March 6, 2025, of the 44 evaluable patients in this study, 29 patients had left-sided, RAS/RAF wild-type metastatic colorectal cancer. Of these 29 patients, 7 achieved partial responses (ORR of 24.1%) and 17 had stable disease (including 11 tumor shrinkage stable disease), with a DCR of 82.8%. The median DOR of the 6 confirmed responders was 32 weeks, of which 2 patients with partial responses were still receiving treatment at the time of data cutoff. In the remaining evaluable patients with greater difficulties in baseline characteristics (such as right side, RAS/RAF mutations), the DCR reached 46.7%. EMB-01 also showed a tolerable safety profile at 1,600 mg once a week.

As of the last practicable date, there is no EGFR/cMET bispecific antibody approved for the treatment of colorectal cancer in the world. EMB-01 is the first EGFR/cMET bispecific antibody in the world to enter Phase II trials for the treatment of colorectal cancer, and is expected to become one of the first EGFR/cMET bispecific antibodies targeting colorectal cancer to be marketed in the world.

Key product EMB-06 (BCMA/CD3)

EMB-06 is the first T cell engager developed by EpiMed Biopharma. It is a recombinant humanized bispecific antibody targeting BCMA and CD3 for the treatment of multiple myeloma and autoimmune diseases.

By the end of 2024, EMB-06 had completed Phase I clinical trials in the dose escalation phase of R/R MM, demonstrating strong anti-tumor activity while maintaining good safety. At the highest evaluated dose level (120 mg to 300 mg), the overall response rate of EMB-06 reached 91.7%, and the complete response rate reached 33.3%.

It is worth noting that EMB-06 has a low incidence of cytokine release syndrome and neurotoxicity. In a phase I study of EMB-06 in patients with R/R MM, the incidence of cytokine release syndrome was only 25%, and all of them were mild (grade 1 or 2).

Based on its good safety profile, EMB-06 is also expanding into the field of autoimmune diseases. In September 2024, EpiMed Bio and Vignette Bio, Inc. (later acquired by Candid), which focuses on developing T cell engagement molecules for the treatment of autoimmune diseases, reached a cooperation agreement on EMB-06, with a total amount of up to US$635 million.

Key product EMB-07 (ROR1/CD3)

EMB-07 is a potential first-in-class bispecific antibody that can simultaneously target CD3 and ROR1. As the world's leading ROR1-targeted T cell engager in clinical development, EMB-07 is expected to become a new treatment for cancers that express ROR1, addressing key unmet needs in the field of oncology, including hematological tumors and solid tumors.

As of the Latest Practicable Date, there are no marketed ROR1/CD3 T cell engagers for the treatment of lymphoma in the world, while there are two clinical-stage ROR1/CD3 bispecific antibody drug candidates for the treatment of lymphoma in the world. As of the Latest Practicable Date, EMB-07 is still the only clinical-stage ROR1/CD3 bispecific antibody drug candidate for the treatment of lymphoma in China.

Innovent Biologics is conducting a Phase I trial of EMB-07 as a monotherapy in patients with advanced solid tumors and lymphomas in China and Australia, and preliminary efficacy signals were observed in the lymphoma cohort during the dose escalation phase.

Based on its high-potential self-developed pipeline, EpiMed Biopharma has established multiple global outsourcing collaborations with a total transaction value of more than US$2.1 billion, ranking second in the world in the T cell engager field.

In addition to the above-mentioned collaboration with Vignette Bio, Invitrogen has recently entered into an outsourcing agreement with Juri for the KLK2/CD3 T cell adapter, with a total potential transaction value of up to US$210 million.

Conclusion

According to the prospectus, EpiMed Biopharmaceuticals will achieve revenue of 460 million yuan and net profit of 47.7 million yuan in 2024, a significant improvement from the loss of 600 million yuan in 2023. Although EpiMed Biopharmaceuticals has no commercial products yet, it has achieved self-sustaining revenue through service revenue related to external authorization and cooperation agreements.

Looking ahead, with the advancement and commercialization of core products, as well as strong self-research and BD capabilities, Innovent Biologics is expected to carve out a niche in the field of bispecific antibodies.

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