Jiasheng Biologics' GB261 Enters Global Spotlight as Third Chinese Firm Surpasses $3.1B in NewCo Deal, Files for IPO

Today, Genor Biopharma announced that it has entered into a license agreement and an equity agreement with TRC 2004 (the Licensee, a company co-founded by Two River and Third Rock Ventures). Pursuant to the license agreement, Genor Biopharma has agreed, among other things, to grant the Licensee an exclusive global license (excluding China) to develop, use, manufacture, commercialize, and otherwise exploit GB261.

Pursuant to the terms of the License Agreement and Equity Agreement, as consideration for the license, Genor Biopharma will receive: 1) a substantial equity stake in the Licensee; 2) an upfront payment of tens of millions of U.S. dollars; 3) milestone payments of up to US$443 million (approximately RMB 3.16 billion); and 4) tiered royalties ranging from single-digit to double-digit percentages of net sales.

GB261 is a novel differentiated CD20/CD3 bispecific T-cell engager (TCE) featuring ultra-low CD3 binding affinity and intact Fc functions (ADCC and CDC).

It significantly inhibits the growth of rituximab-resistant cancer cells through in vitro assays and in vivo models, with lower cytokine release compared to similar products while activating T cells. Therefore, GB261 is a highly promising bispecific therapeutic antibody for B-cell malignancies. With significant competitive advantages over other CD3/CD20 inhibitors, GB261 is poised to become a superior and safer T-cell engager therapy.

Genor Biopharma has previously successfully completed a Phase 1/2 multicenter study in China and Australia targeting B-NHL (B-cell non-Hodgkin lymphoma, including diffuse large B-cell lymphoma [DLBCL] and follicular lymphoma [FL]). As of October 2023, the Phase I/II clinical trial of GB261 had completed dose escalation, demonstrating favorable safety and pharmacokinetic profiles as well as clinical antitumor activity.

At the 65th American Society of Hematology (ASH) Annual Meeting in late 2023, Genor Biopharma also presented preliminary clinical safety and efficacy results from the Phase I/II study of GB261, led by Peking University Cancer Hospital, in a poster presentation. The poster showed:

1) As of June 17, 2023, 47 patients with relapsed/refractory B-cell non-Hodgkin lymphoma (r/r B-NHL) (diffuse large B-cell lymphoma [DLBCL]: 76.6%; follicular lymphoma [FL]: 23.4%) were enrolled in the GB261 trial and received either fixed-dose or step-up dosing regimens, with doses ranging from 1 mg to 300 mg. Among the 22 patients evaluable for efficacy within the dose range of 3 mg to 100 mg, the overall response rate (ORR) was 73% (16/22), and the complete response rate (CRR) was 45.5% (10/22).

2) Preliminary clinical data demonstrated a favorable safety and tolerability profile: Among patients evaluable for safety (n=47), the incidence of cytokine release syndrome (CRS) was 12.8% (6/47), with all cases being mild and transient. The incidence of CRS in the 100 mg dose cohort was also low at 14.3% (2/14). All CRS events were Grade 1 (8.5%, 4/47) or Grade 2 (4.3%, 2/47) according to the ASTCT criteria (Lee et al.), with no Grade 3 CRS reported. No treatment interruptions occurred, and no patients required tocilizumab treatment. The median duration of CRS was 7 hours. No cases of immune effector cell-associated neurotoxicity syndrome (ICANS) were reported.

3) Its pharmacokinetic (PK) profile shows that GB261 has a long half-life, with an effective half-life of approximately 2–3 weeks, supporting a dosing regimen every 3–4 weeks.

Overall, the clinical trial results of GB261 demonstrate that GB261 exhibits a favorable safety/efficacy balance in patients with B-NHL who have previously failed multiple treatment regimens. Compared with other CD20/CD3 bispecific antibodies, GB261 has a superior safety profile, particularly characterized by cytokine release syndrome (CRS) that is mild, transient, and low in incidence. Following GB261 treatment, early, deep, and durable efficacy was observed.

Furthermore, clinical benefits of GB261 were observed in patients refractory to other CD20/CD3 bispecific antibodies, providing clinical support for the unique and highly differentiated mechanism of action of GB261.

The characteristics of GB261 enable its therapeutic potential to extend beyond oncology, making it also suitable for various immunological and autoimmune indications with significant unmet medical needs among patients. This collaboration with TRC 2004 will primarily focus on exploring the potential of GB261 in autoimmune diseases.

Unlike most previous overseas expansions by Chinese pharmaceutical companies, Genor Biopharma’s latest international venture adopts the NewCo model (establishing a new company in collaboration with overseas capital), whereby Genor Biopharma jointly established TRC 2004 with two US-dollar funds, Two River and Third Rock Ventures.

In fact, the NewCo model is emerging as a new trend for Chinese innovative drugs going global. Since the beginning of this year, numerous Chinese pharmaceutical companies have successfully expanded overseas through this approach.

In May this year, Hengrui Medicine announced the out-licensing of its proprietary GLP-1 product portfolio to Hercules for consideration. Hercules was established in May 2024 with $400 million in joint funding from Bain Capital, Atlas Ventures, RTW Investments, and Lyra Capital, focusing on the development of biopharmaceuticals. The investors in Hercules will be responsible for the establishment and operation of the U.S.-based entity. Upon completion of the transaction, in addition to subsequent milestone payments and sales royalties, Hengrui Medicine will also hold a 19.9% equity interest in the product value as a shareholder.

In the press release, Dr. Jiang Ningjun, Director and Chief Strategy Officer of Hengrui Medicine, stated, “Collaborating with top-tier investment funds such as Bain Capital, Atlas Ventures, RTW Investments, and Lyra Capital represents a new model for Hengrui Medicine, helping to further broaden the internationalization path of its rich innovative pipeline and better serve unmet medical needs worldwide.”

This July, Keymed Biosciences announced that it has licensed the global rights outside Greater China for its two novel bispecific antibody candidates, CM512 and CM536, to Belenos Biosciences. Under the agreement, Keymed will receive a $15 million upfront payment, $170 million in milestone payments, and tiered royalties on sales. Belenos is controlled by the healthcare-focused investment fund OrbiMed, which holds a 50.26% stake, while Yiqiao Hong Kong, a wholly-owned subsidiary of Keymed, holds a 30.01% stake. Chen Bo, Chairman of Keymed, will join the board of directors of Belenos.

In recent years, China’s innovative drug sector has witnessed rapid development, yielding high-quality outcomes. Whether it is the acquisition of Chinese biotech firms such as Gracell Biotechnologies, Sinocelltech, and Prothena by top-tier multinational corporations (MNCs), the earlier trend of major MNCs actively sourcing pipelines or technology platforms in China, or the newly discussed “NewCo” model, these developments have provided domestic biotech companies—currently facing a challenging financing environment and high R&D expenditures—with new pathways to accelerate their survival through the industry winter.

The NewCo model offers distinct advantages by licensing the overseas rights of innovative Chinese drugs to a newly established entity. In return, Chinese pharmaceutical companies receive equity stakes and financial support, while retaining a significant proportion of overseas rights as the products advance into the commercialization phase abroad. Amid the current downturn, this strategy presents a win-win scenario: it provides domestic pharmaceutical firms with much-needed capital infusion and risk diversification opportunities, while also offering overseas funds a novel exit pathway.