• The drug marketing license application (NDA) for the treatment of moderate to severe atopic dermatitis (NDA), a core product in the field of autoimmunity, has been accepted by the China Drug Administration and included in the priority review and approval process; CM310
• Phase III clinical study data on the treatment of chronic sinusitis with nasal polyps were positive, and all major endpoints were fully met. It is expected that the NDA will be declared for this indication in 2024; at the same time, phase III clinical studies on the treatment of moderate to severe atopic dermatitis and seasonal allergic rhinitis in adolescents will be initiated and promoted separately;
• An exclusive global licensing agreement has been signed with AstraZeneca for the development, registration, production and commercialization of CMG901, the potential world's first antibody-conjugation drug targeting Claudin 18.2, and has received a down payment of $63 million; as of the date of this announcement, AstraZeneca has conducted a number of clinical studies on CMG901/AZD0901 in the treatment of advanced solid tumors;
• The company is steadily promoting commercial production capacity building, quickly building a commercial team, and fully preparing to start commercialization.

CHENGDU, March 27, 2024/PRNewswire/ -- Connoya (HKEx code: 02162) released its 2023 performance report. In 2023, the company's various businesses accelerated and made landmark progress in various areas such as innovative drug development, production base construction, and commercialization preparations.

Dr. Chen Bo, Co-Founder, Chairman and CEO of Connoah: “Looking back at 2023, Connor has achieved breakthrough results in all areas. We focus on innovative treatments and are deeply involved in differentiation. The first drug marketing license application for the core product, spoximab, was accepted. Clinical research on multiple indications and candidate products went hand in hand, and generated revenue and accelerated research and development progress through licensing and cooperation. The company continues to promote the release of production capacity, rapidly improve production and commercialization capabilities, lay out the entire industry chain in depth, and make steady steps towards a comprehensive innovative biopharmaceutical company. “This year, Konoah is expected to welcome its first commercial product. We expect the innovative drugs developed by the company to benefit the clinical faster and more widely, and continue to provide patients with new treatment options that are more competitive, high-quality, and affordable worldwide.”

Core product progress and R&D pipeline highlights

• Sproximab (CM310) - The first self-developed IL-4Rα antibody drug in China

A phase III clinical study on treating moderate to severe atopic dermatitis in adults was promoted and completed. The study results showed that when treated with spiquimab for 16 weeks, the proportion of patients who achieved EASI-75 was 66.9%, and the proportion that achieved an IGA score of 0 or 1 point and an improvement of at least 2 points from the baseline was 44.2%. There were significant improvements in itching control and quality of life, and good safety characteristics. The application for marketing licensing of spoximab for the treatment of moderate to severe atopic dermatitis in adults has been accepted by the China Drug Administration and included in the priority review and approval process;

In February 2024, a randomized, double-blind, placebo-controlled phase III clinical study to evaluate the efficacy and safety of spoximab in young people with severe atopic dermatitis was initiated, and patient enrollment is currently underway;

Continue to advance the phase III clinical study on the treatment of chronic sinusitis with nasal polyps. Data disclosure and statistical analysis were completed in December 2023. The data results were positive. The common main endpoints were fully compliant, with highly significant statistical differences, and good safety. It is expected that NDA will be declared for this indication in 2024;

Initiated and promoted a phase III clinical study to evaluate the treatment of patients with seasonal allergic rhinitis with septicibizumab under background treatment, and a multi-center, single-arm phase II clinical study to evaluate the safety of patients with seasonal allergic rhinitis;

Key phase II/III clinical studies for the treatment of moderate to severe asthma are being carried out by authorized partner CSPC Pharmaceutical Group, and patients are currently being enrolled.

• CMG901/AZD0901（Claudin 18.2 antibody-conjugated drug)

In February 2023, an exclusive global licensing agreement was signed with AstraZeneca for the R&D, registration, production and commercialization of CMG901, and a down payment of US$63 million has been received; as of the date of this announcement, AstraZeneca has carried out a number of clinical studies on CMG901/AZD0901 in the treatment of advanced solid tumors;

In November 2023, the latest data from a phase I clinical study treating advanced gastric cancer/gastroesophageal junction adenocarcinoma was released in the form of an oral report at the American Society of Clinical Oncology General Conference Series (ASCO Prescription Series). The confirmed objective response rate (ORR) of 89 evaluable patients with Claudin 18.2 positive gastric cancer or gastroesophageal adenocarcinoma in the three dose groups was 33%, and the disease control rate (DCR) was 70%. Among them, the confirmed ORR in the 2.2 mg/kg dose group was 42%, and the median progression-free survival (mPFS) was 4.8 months.

• CM313 (CD38 antibody)

Continue to advance phase I clinical trials to evaluate the safety, tolerability, pharmacokinetics, immunogenicity and initial efficacy of CM313 monotherapy in hematologic malignancies such as relapsed/refractory multiple myeloma and lymphoma;

In June 2023, the latest data from the CM313 Phase I clinical study on relapsed/refractory multiple myeloma and relapsed/refractory lymphoma was released in the form of a poster at the 28th European Society of Hematology (EHA) Annual Meeting. The overall safety of CM313 was good in the study, showing initial efficacy in treating patients with relapsed/refractory multiple myeloma at a dose level of ≥2.0 MG/KG;

Randomized, double-blind, placebo-controlled, dose-escalating, and multiple-dose clinical studies evaluating the safety, tolerability, pharmacokinetics, immunogenicity, and initial efficacy of CM313 in systemic lupus erythematosus subjects have continued to advance;

In December 2023, the latest data from a single-arm, open, exploratory clinical study initiated by a researcher evaluating CM313 to treat primary immune thrombocytopenia in adults was published in the form of a poster at the 65th American Society of Hematology (ASH) annual meeting. As of June 30, 2023, a total of 21 patients were enrolled in the study. 7 subjects completed 8 treatments, and the follow-up period was at least 8 weeks. Of the 7 patients, 100.0% (7/7) achieved platelet counts greater than 50 × 10 within 8 weeks after initial administration⁹/L, median remission time of 1 week (range 1-3).

• CM326 (TSLP antibody)

Continue to advance randomized, double-blind, placebo-controlled phase II clinical studies to evaluate the efficacy and safety of CM326 in the treatment of adult patients with severe atopic dermatitis;

Continue to advance multicenter, randomized, double-blind, placebo-controlled phase IB/IIa clinical trials to evaluate the safety, tolerability, pharmacokinetics/pharmacokinetics, immunogenicity, and initial efficacy of CM326 in subjects with chronic sinusitis with nasal polyps;

A phase II clinical study for the treatment of moderate to severe asthma was carried out, and patients are currently being enrolled in the group.

• Other pipeline product developments:

CM355/ICP-B02 (CD20xCD3 bispecific antibody)

Phase I/II clinical studies are underway to evaluate the safety, tolerability, pharmacokinetics, and initial antitumor activity of CM355 in the treatment of relapsed/refractory non-Hodgkin lymphoma patients. As of the date of this announcement, the objective response rate (ORR) of all 13 patients receiving doses of 6 mg and above reached 100%.

CM336 (bCmaxCD3 bispecific antibody)

Continue to advance phase I/II clinical studies to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of CM336 in the treatment of recurrent or refractory multiple myeloma.

CM350 (GPC3xCD3 bispecific antibody)

Continue to advance phase I/II clinical studies to evaluate the safety, tolerability, pharmacokinetics and initial efficacy of CM350 in the treatment of patients with advanced solid tumors.

CM338 (MASP-2 antibody)

Continue to advance phase II clinical studies to evaluate the efficacy and safety of CM338 injections in subjects with immunoglobulin A nephropathy (IgAN).

CM369/ICP-B05 (CCR8 antibody)

Continue to advance phase I clinical studies to evaluate the safety, tolerability, pharmacokinetic characteristics and efficacy of CM369 for the treatment of advanced solid tumors and recurrent or refractory non-Hodgkin lymphoma subjects. In the future, we will explore the application of CM369 in combination with other immunotherapies in the treatment of various cancer indications.

CM383 (Abetafibrillar antibodies)

A clinical trial application for CM383 was submitted in February 2024, and a phase I clinical study on the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of single dose escalation administration in healthy subjects will soon be carried out.

Financial data and company operating priorities

• Revenue of 350 million yuan was achieved in 2023, mainly from authorized cooperation with AstraZeneca; annual R&D expenditure increased to 590 million yuan, continuing to invest in differentiated candidate pipeline research and development; as of December 31, 2023, the company had about 2.7 billion yuan in term deposits, cash and bank wealth management products.
• Accelerate the construction of the production base in Chengdu. All designs at the base comply with the cGMP regulations of the State Drug Administration and the US FDA. Currently, the production capacity can reach 18,600 liters to guarantee subsequent clinical use and commercial dosage in multiple pipelines, including spoxibizumab.
• The company continues to recruit talents to meet the growing needs of commercial product sales, R&D, clinical, production and company operations. The commercialization core team was quickly set up to prepare for a comprehensive commercial listing.

In the future, Konoah will continue to rapidly advance differentiated pipeline research and development in China and the world, and comprehensively prepare for the commercialization of pipeline products in the later stages. At the same time, in order to speed up the commercialization process of drug candidates, we will actively explore and establish strategic partnerships in China and around the world to promote innovative drugs to benefit patients more quickly through various forms such as joint development, cooperation and licensing. The company will further enhance production capacity that meets cGMP requirements, reduce costs and improve efficiency, move rapidly towards building a comprehensive biopharmaceutical company covering the entire chain, and continuously strive to develop, produce and commercialize more competitive, high-quality, and affordable innovative drugs for patients around the world.

About Conocoia

Connor (HKEx code: 02162) is a comprehensive innovative biopharmaceutical company focusing on independent development and production of innovative drugs. It is committed to providing patients with innovative therapies that are more competitive, high-quality, and affordable worldwide. With the inventors of PD-1 antibody drugs pioneered and approved for marketing in the world and China as the core, the main leadership team are all top experts in the biopharmaceutical industry, with world-class scientific and technological achievements transformation and outstanding domestic and international industrialization experience.

The company insists on independent innovation, has efficient and integrated internal R&D capabilities, and relies on proprietary platforms such as the novel T-cell redirection (NTCe) bispecific platform to build an industry-leading drug discovery engine. The company focuses on the treatment of diseases such as autoimmune diseases and tumors, and has built a differentiated product pipeline to create a variety of potentially world-first or best-in-class drug candidates. Many developments are in leading positions globally or domestically. Connoya deeply lays out the entire biopharmaceutical industry chain, covering the entire cycle from molecular discovery to commercial production. The international production base under construction meets the cGMP requirements of the National Drug Administration, the US FDA, and the European Union EMA, with a total production capacity of 18,600L.

For more information about Conoah, visit.