Stock code: 688266 Stock abbreviation: Zelgen Pharmaceutical Announcement No.: 2024-042

Suzhou Zelgen Biopharmaceutical Co., Ltd

Announcement on Voluntary Disclosure of Clinical Research Progress of ZG005 for Injection

The board of directors and all directors of the company guarantee that there are no false records, misleading statements or material omissions in the content of this announcement, and assume legal responsibility for the authenticity, accuracy and completeness of its content in accordance with the law.

Important Content Notes:

Suzhou Zelgen Biopharmaceutical Co., Ltd. (hereinafter referred to as the "Company") has conducted clinical research on a number of new antibody drugs

The results were selected for oral presentations or walls at the 27th Chinese Congress of Clinical Oncology and the 2024 CSCO Academic Annual Meeting

ZG005, a bispecific antibody targeting TIGIT/PD-1, for I/II in subjects with advanced solid tumors

The preliminary results of the phase phase clinical trial (protocol number: ZG005-001) were selected as an oral report in the special session on the research and development of new anti-tumor drugs and technologies. Preliminary data showed that ZG005 demonstrated good tolerability, safety and anti-tumor efficacy in the Phase I/II dose escalation and expansion study. In particular, patients with advanced cervical cancer have significant efficacy and good safety after treatment with ZG005.

The above matters will not have a material impact on the Company's near-term results. Due to the high-tech, high-risk, and high value-added characteristics of pharmaceutical products, the pre-research and development of drugs and the long cycle and many links of products from development, clinical trials, approval to production, are easily affected by some uncertain factors, and the company will fulfill its information disclosure obligations in a timely manner according to the follow-up progress. Investors are advised to make prudent decisions and pay attention to preventing investment risks.

In order to keep investors abreast of the company's relevant research results, ZG005 for injection is now available until 2024

The clinical data and latest progress announcement on August 6 are as follows:

First, the basic situation of drugs

ZG005 is a recombinant humanized anti-PD-1/TIGIT bispecific antibody powder injection, which is an innovative tumor immunity

Epidemic treatment biologics, registered as Class 1, are expected to be used for the treatment of a variety of solid tumors. According to public inquiries, ZG005 is one of the first drugs with the same target to enter clinical studies in the world, and no drug with the same mechanism has been approved for marketing in the world.

ZG005 has the effect of dual-targeting blocking PD-1 and TIGIT, which can effectively block PD-1

and its ligand PD-L1 signaling pathway, which in turn promotes T cell activation and proliferation; It can also be effectively blocked

Signaling pathways such as TIGIT and its ligand PVR promote the binding of PVR to CD226 to produce costimulatory activation signals

, which in turn promotes the activation and proliferation of T cells and NK cells, and produces synergistic enhancements to the immune system's ability to kill tumor cells after the two targets are blocked at the same time.

Data from the Phase I/II clinical study of dose escalation, tolerability, safety, pharmacokinetics, and multi-cohort expansion of ZG005 in patients with advanced solid tumors have shown that ZG005 monotherapy has shown good results in multiple advanced solid tumors

Good tolerability and safety profile and good anti-tumor efficacy (data as of April 16, 2024 please refer to for details.)

See the Company's "Voluntary Disclosure ZG005 and ZGGS18 in 2024" disclosed on May 25, 2024

The United States Society of Clinical Oncology (ASCO) Annual Meeting released an announcement on clinical data and latest progress (Announcement No. 2024-018).

2. Progress in clinical research of ZG005 for injection

As of August 6, 2024, ZG005, a bispecific antibody targeting TIGIT/PD-1, is used in advanced stages

The Phase I/II clinical trial (protocol number: ZG005-001) in subjects with solid tumors enrolled 46 patients with advanced cervical cancer, of whom the majority (87%, 40/46) had received at least one prior systemic antineoplastic agent and some (28%, 13/46) had prior use of immune checkpoint inhibitors.

In terms of efficacy, there were 36 efficacy-evaluable cervical cancer subjects (1 in the 3 mg/kg group, 10 mg/kg

20 in the group and 15 in the 20 mg/kg group), 2 achieved a complete response (CR) and 12 had a partial response (PR),

Fifteen patients had stable disease (SD), an objective response rate (ORR) of 38.9%, and a disease control rate (DCR).

to 80.6%. Fifteen subjects with cervical cancer who received ZG005 at a dose of 20 mg/kg (4 of which were immunized

checkpoint inhibitor resistance) in 1 case of CR and 7 cases of PR, with an ORR of 53.3% and a DCR of 86.7%;

11 patients who received ZG005 20 mg/kg at the second line or above and were naïve with immune checkpoint inhibitors

In cancer patients, ORR and DCR can be 66.7% and 100.0%, respectively.

In terms of safety, the vast majority (72.2%) of all 97 subjects exposed to ZG005

Treatment-related adverse events (TRAEs) were of grade 1 or 2 severity. The most common TRAEs are real

Laboratory indicators were abnormal, including elevated aspartate aminotransferase, alanine aminotransferase, etc.

In summary, ZG005 has demonstrated good tolerability, safety and outstanding anti-tumor efficacy, especially in patients with advanced cervical cancer treated with a dose of 20 mg/kg, and the existing results show the potential of ZG005 in combination with other treatment regimens.

3. Risk Warning

This disclosure of the progress of clinical research of ZG005 for injection will not have a significant impact on the company's near-term results

Sound. Due to the high-tech, high-risk, and high value-added characteristics of pharmaceutical products, the pre-research and development of drugs and the long cycle and many links of products from development, clinical trials, approval to production, are easily affected by some uncertain factors, and the company will fulfill its information disclosure obligations in a timely manner according to the follow-up progress. Investors are advised to make prudent decisions and pay attention to preventing investment risks.

Board of Directors of Suzhou Zelgen Biopharmaceutical Co., Ltd

September 26, 2024