SAN FRANCISCO, USA, Suzhou, China, June 19, 2024/PRNewswire/ -- At several annual international oncology conferences this year, Cinda Biotech presented clinical data on various cancer drug candidates in the form of 10 oral reports and 15 posters. On June 17, Cinda Biotech held an investor conference call to interpret the clinical data of the product in detail, and also introduced the company's current R&D strategy focusing on global innovation, as well as the early research mechanisms, development strategies, and development direction of the differentiation of various middle- and early-stage molecules. Ms. Yu Fei, Chief Financial Officer of Cinda Biotech, Dr. Zhou Hui, Senior Vice President of Oncology Development, and Dr. He Kaijie, Vice President of Oncology Biology and ADC Pharmaceutical Research, attended the conference and reported.

(Detailed sharing materials can be downloaded from the company's official website, link:)

Tumor Development Strategy: In-depth LayoutIO+ADC to address unmet global clinical needs

Advances in science and technology have continuously improved the survival rate and quality of life of cancer patients. However, there are still many unmet clinical needs for cancer treatment. For example, immunotherapy response rates represented by PD-1 are limited, and responses to most diseases will eventually progress; the efficacy of current major treatments (such as anti-angiogenic drugs) is limited.

Cinda Biotech has established a product pipeline with 36 new drug types, and the oncology product pipeline has 22 drug candidates. By leveraging the world's leading antibody technology platform, developing differentiated linker-payloads (linker-payloads), and deep understanding of oncology science, Cinda Biotech deeply lays out “tumor immunity (IO) + antibody drug conjugates (ADC)” to achieve the strategic goal of global innovation and the “endless creation” brand positioning of the tumor pipeline.

Major product developments:PoC+MRCT to steadily advance the globalization process of innovative products

The company's oncology product line promotes innovative drug development through clinical verification (Proof of Concept (PoC) and global multi-center clinical trials (MRCT). Currently, several high-potential molecules have entered the clinical research stage, including the three new global molecules IBI363, IBI343, and IBI389, which have been interpreted in detail this time, and has more bispecific antibodies and ADC innovators in the early global clinical development process.

IBI363: The world's first PD-1/IL-2α-BiAs has shown encouraging cross-tumor efficacy in immunotherapy and cold tumors, and the potential for next-generation IO therapy is beginning to emerge

As the world's first drug independently developed by Cinda Biotech, IBI363 represents the company's continuous R&D and innovation in the IO field. This time, for the first time, the company reported its new mechanism of action and clinical development progress worldwide.

• In terms of molecular design, the unique idea of alpha bias and reduction of beta and gamma greatly enhances the treatment window of IL-2; through the specific traction of PD-1, T-cells expressing PD-1 and CD25 can be selectively stimulated and amplified in tumors, thereby exerting anti-tumor effects.
• IBI363 showed excellent pharmacokinetics (IgG-like PK) and low immunogenicity as antibodies. This brought the dose of IBI363 to an unprecedented level, showing good safety and breaking through the safety concerns of IL-2 therapy.
• In phase 1 clinical trials involving more than 300 subjects, IBI363 has seen encouraging efficacy in all representative tumors, including wild non-small cell lung cancer with previous immunotherapy, melanin that has received immunotherapy, mucosal melanoma that has not received immunotherapy, and cold-tumor intestinal cancer, showing the broad-spectrum anti-tumor effects of IBI363.
• Based on encouraging clinical data, Cinda Biotech is further expanding the clinical development of IBI363, including further following up on clinical results of a high dose of 3 mg/kg to determine subsequent development doses, carrying out phase 2 clinical trials in the US, and exploring more co-drug use opportunities.

The two models are based onThe innovative technical forms IBI343 and IBI389 targeting CLDN18.2 showed breakthrough efficacy

IBI343: Innovative Topo1i CLDN18.2 ADC, the world's first ADC drug showing breakthrough efficacy in pancreatic cancer

• The world's leading innovativeTopO1i CLDN18.2 ADC: IBI343 uses an excellent molecular design, is based on the world's leading glycosylated fixed-point coupling technology, and has high stability in vivo; uses a strong payload (ixitecan) and has a strong bystander killing effect; the fC silencing effect ensures no ADCC-mediated gastrointestinal toxicity to ensure high safety in vivo; and strong targeting effects brought about by all-human origin and highly tolerated CLDN18.2 antibodies.
• The world's first to show a breakthrough in efficacy in pancreatic cancerADC drugs: Preliminary phase I data from IBI343 for pancreatic cancer patients who have received at least first-line treatment showed that the objective remission rate (ORR) was 40% in CLDN18.2 IHC1/2/3+ ≥ 60% pancreatic cancer subjects (n=10) treated with 6 mg/kg IBI343.
• ExceptIn addition to PDAC, IBI343 showed clear therapeutic effects in late-line gastric cancer treatmentPhase 3 of its MRCT clinical phase is being prepared.

IBI389: The world's first anti-CLDN18.2/CD3 bispecific antibody, the first T-cell connector with obvious beneficial signals observed in pancreatic cancer

• IBI389 is the world's first molecule independently developed by Cinda Biotech. By simultaneously combining CLDN 18.2 expressed on tumor cells with CD3 on T cells, it redirects T cells to tumor cells and induces T cells to kill tumor cells. Preclinical results showed that even in cell lines with low CLDN18.2 expression, IBI389 can still bind to tumor cells, showing obvious anti-tumor efficacy.
• IBI389 showed potential efficacy signals in advanced gastric cancer and pancreatic cancer, including those with low expression of CLDN 18.2. In particular, as the world's first CLDN18.2/CD3 dual antibody to publish clinical data, IBI389 observed clear signs of benefit in pancreatic cancer, achieving a breakthrough in the field of difficult to treat cancer types with this innovative drug form.
• According to ASCO clinical data, among 27 pancreatic cancer subjects treated with 600 μg/kg IBI389 and at least one post-baseline tumor evaluation, the objective response rate (ORR) was 29.6%, the confirmed objective remission rate (CoRR) was 25.9%, and the disease control rate (DCR) reached 70.4%. Among 18 subjects with CLDN18.2 IHC 2/3 +≥ 40%, CoRR was 38.9% (95% CI: 17.3-64.3).
• Based on the unique advantages shown by IBI343 and IBI389 in early clinical and clinical development, Innovent Biotech is promoting the development of IBI343 MRCT phase 3 clinical trials for gastric cancer treatment, and exploring IBI343 and IBI389 empirical clinical trials for intractable pancreatic cancer.

Looking forward to the future, Cinda Biotech will continue to promote clinical development of oncology product lines with high quality, explore unmet medical needs in the field of cancer treatment under the guidance of the “IO+ADC” strategy, and promote global innovation.Dr. Zhou Hui, Senior Vice President of Oncology Development, Cinda Biopharmaceutical GroupHe said, “As one of the few biopharmaceutical companies with leading R&D capabilities in the IO and ADC fields, we will have a unique competitive advantage in next-generation innovation in cancer treatment, adhere to the mission of developing high-quality biopharmaceuticals that ordinary people can use, benefit more patients, and help implement the Healthy China 2030 Strategy.”

About Cinda Biotech

The mission and goal of Cinda Biotech is to develop high-quality biopharmaceuticals that ordinary people can afford to use. Founded in 2011, Cinda Biotech is committed to developing, producing and selling innovative drugs for major diseases such as oncology, autoimmunity, metabolism, and ophthalmology, so that our work can benefit more lives. The company has been approved for listing 10 products. They are cindilizumab injections (dabershu), bevacizumab injection (dayoutong)), adalimumab injection (sulisin), rituximab injection (dabervac), pemitinib tablets (dabartan), orebatinib tablets (Nelik), remoxieumab injection (xiranze)) *, ceptinib capsules (retinoid) *, igiorense injection (fukosu) and tolecizumab injections (Cimpiroc). Currently, there are also 4 varieties in the NMPA review. 4 new drug molecules have entered phase III or key clinical research, and 18 new drug types have entered clinical research.

The company has reached more than 30 strategic partnerships with international partners such as Eli Lilly, Roche, Sanofi, Adimab, Incyte, and MD Anderson Cancer Center. While continuously developing innovative drugs and seeking its own development, Cinda Biotech adheres to the people-centered development philosophy of economic construction. Over the years, we have always been scientific and kind, adhering to the “patient-centered” approach, caring for patients and their families, and actively fulfilling social responsibilities. The company has successively initiated and participated in a number of drug charity aid projects, so that more and more patients can benefit from advances in life science and can buy and use high-quality biopharmaceuticals. Up to now, the Cinda Biotech Patient Assistance Program has benefited more than 170,000 ordinary patients, with a total value of 3.4 billion yuan in drug donations. Cinda Biotech hopes to work with everyone to raise the level of development of China's biopharmaceutical industry to meet people's accessibility to medicine and people's pursuit of a better life and health.

For more information, please visit the company website: Biologics.

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