SUZHOU, March 29, 2024/PRNewswire/ -- Corning Jerry Biopharmaceuticals (stock code: 9966.HK) announced its full year results and recent business developments for the year ended December 31, 2023.

Dr. Xu Ting, Chairman and President of Corning Jerry said:“In 2023, Corning Jerry will continue to target clinical needs and insist on differentiated innovation. The company already has one marketed product and three products in the clinical phase of registration. We will continue to improve our antibody engineering platform and develop safe and effective new anti-tumor drugs. At the same time, we will accelerate clinical development, product launch, and international cooperation.”

Financial Overview

• The total revenue for 2023 was RMB 218.77 million, an increase of 31.12% over the previous year.
• In 2023, we achieved product revenue of RMB 195.55 million, an increase of 32.54% over the previous year.
• R&D expenditure in 2023 was RMB 407.52 million, a year-on-year decrease of 12.97%.
• The total loss for 2023 was RMB 210.59 million, a year-on-year decrease of 35.35%.
• A capital market placement was completed, and the net capital raised was approximately RMB 329.21 million. The financial situation is stable, with cash reserves of RMB 1407.24 million as of December 31, 2023.

Business summary

1. Product pipeline

The company has a product pipeline with significant differentiation advantages and strong international competitiveness, covering new anti-tumor drugs such as single-domain antibody/monoclonal antibodies, multi-functional antibodies and antibody conjugates. One of these products is KN035 (the world's first subcutaneous PD- (L) 1 inhibitor, Envolizumab injection, product name: Enweida) It has been approved for marketing in China. 3 products are in the late-stage clinical development stage, and 2 new drug molecules in the rich early R&D pipeline have entered the clinical research stage.

KN046

A BsAb immune checkpoint inhibitor that targets two immune checkpoints PD-L1 and CTLA-4 at the same time is a potentially groundbreaking next-generation tumor immunization drug. KN046 has conducted nearly 20 clinical studies in China, the United States and Australia, covering more than 10 types of tumors at different stages, including non-small cell lung cancer, pancreatic cancer, thymus cancer, liver cancer, esophageal squamous cell carcinoma, and tri-yin breast cancer. The results show that patients have the advantage of survival benefits. Currently, more than one registered clinical study on KN046 is ongoing.

Key developments during the reporting period

• In May 2023, for the phase III clinical study of KN046 combined with platinum-containing chemotherapy for patients with advanced unresectable or metastatic squamous non-small cell lung cancer (sq NSCLC), the Independent Data Monitoring Committee recommended continuing the study and further collecting subsequent overall survival (OS) follow-up data until the final OS analysis.
• In June 2023, the results of the phase I clinical study of KN046 to treat advanced solid tumors (especially nasopharyngeal cancer) were published online in the official journal of the International Association for Immunotherapy of Cancer (SITC)Journal for Immunotherapy of Cancer(JITC). Research results show that KN046 has good tolerability and anti-tumor efficacy in patients with advanced solid tumors.
• In July 2023, the results of a phase II clinical study of KN046 single-agent treatment of advanced non-small cell lung cancer were published online in a well-known international journal in the field of oncologyEuropean Journal of Cancer. Research results show that KN046 3mg/kg and 5mg/kg monotherapy have good efficacy and safety in patients with squamous and non-squamous advanced non-small cell lung cancer who have failed or are intolerant of previous platinum chemotherapy.
• The phase II clinical study of KN046 combined with axitinib for first-line treatment of advanced non-small cell lung cancer obtained good tolerability, efficacy and safety signals. The relevant results were presented at the European Society of Medical Oncology (ESMO) conference in October 2023.
• Phase I and phase II clinical studies of KN046 treatment of non-small cell lung cancer have achieved good tolerability and OS benefits for non-small cell lung cancer patients who have failed previous immune checkpoint inhibitors (ICI) treatment. The relevant results were presented at the ESMO conference in October 2023.
• In clinical studies of non-small cell lung cancer in combination with chemotherapy, KN046 showed efficacy and OS benefits and good safety in patients with advanced EGFR-sensitive mutations who failed to be treated with epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (EGFR-TKI (s)). The relevant results were presented at the ESMO conference in October 2023.
• The phase II clinical study of KN046 for treating patients with recurrent or metastatic thymic cancer that progressed after first-line chemotherapy achieved good anti-tumor activity and tolerability results for thymic cancer patients who had received at least first-line chemotherapy. As of August 30, 2023, the median OS was immature, showing encouraging signs of survival benefit. The relevant results were presented at the ESMO conference in October 2023.
• In November 2023, regarding the midterm analysis of a phase III clinical study of KN046 combined with albumin paclitaxal/gemcitabine in the treatment of locally advanced unresectable or metastatic pancreatic duct adenocarcinoma without systematic treatment, the Independent Data Monitoring Committee recommended continuing the study and further collecting subsequent OS data until the final OS analysis.

Progress after the reporting period

• The phase II clinical study of KN046 combined with albumin paclitaxel for first-line treatment of advanced trifecta breast cancer achieved encouraging PFS and OS benefits, good tolerability, and controlled safety. The relevant results were published in an internationally renowned journal in February 2024Nature Communications.
• The phase II clinical study of KN046 combined with chemotherapy for first-line treatment of metastatic non-small cell lung cancer showed impressive efficacy and good tolerability. The relevant results were published in Cell in March 2024Cell Reports MedicineFull text published.

Expected milestones for 2024

• The phase III clinical study of KN046 combined with chemotherapy for first-line treatment of squamous non-small cell lung cancer performed final OS analysis.
• The final OS analysis was performed in the phase III clinical study of KN046 combined with chemotherapy for first-line treatment of advanced pancreatic cancer.
• Data related to the phase II clinical study of KN046 combined with axitinib for advanced non-small cell lung cancer were read and are expected to be released in ESMO in October 2024.

KN026

The new generation of HER2 binoclonal antibodies can simultaneously combine two different clinically validated HER2 epitopes, thereby producing potentially excellent curative effects. Clinical study results showed that KN026 showed good initial efficacy and safety for patients with HER2-expressing tumors that had previously been severely treated.

Key developments during the reporting period

• In May 2023, the III clinical study of KN026 combined with injectable docetaxel (albumin binding type) for first-line treatment of HER2-positive recurrent metastatic breast cancer was approved by the National Drug Administration.
• In June 2023, the II clinical study results of KN026 combined with KN046 for the treatment of breast cancer or locally advanced unresectable or metastatic HER2-positive solid tumors other than GC/GEJ were announced at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting. The study results showed that among the 26 patients enrolled, there were significant benefits compared to existing treatments in terms of objective response rate, survival without progression, 12-month survival rate, and safety.
• In July 2023, the first patient administration was completed in a phase III clinical study of KN026 combined with injectable docetaxel (albumin binding type, HB1801) for first-line treatment of HER2-positive recurrent or metastatic breast cancer.
• A phase II clinical study of KN026 combined with docetaxel in first-line treatment of HER2-positive recurrent or metastatic breast cancer showed good efficacy and tolerability. The relevant results were presented at the ESMO conference in October 2023.
• The phase II clinical study of KN026 combined with docetaxel for the new adjuvant treatment of early or locally advanced HER2-positive breast cancer showed good clinical results and acceptable and controllable safety. The relevant results were presented at the ESMO conference in October 2023.
• In November 2023, KN026 combined chemotherapy was recognized as a breakthrough treatment by the Drug Evaluation Center of the State Drug Administration for patients with HER2 positive gastric cancer (and gastroesophageal junction cancer) who failed first-line standard treatment (trastuzumab in combination with chemotherapy).
• Clinical studies of KN026 combined with docetaxel in first-line treatment of HER2-positive recurrent or metastatic breast cancer have achieved good tolerability and clinical benefits. The relevant results were presented at the 46th San Antonio Breast Cancer Congress (SABCS) in December 2023.

JSKN003

A HER2 double antibody ADC developed using Corning Jerry's unique glucose-based fixed-point coupling platform has better serum stability, stronger bystander killing effect, and equivalent tumor killing activity than similar drugs, effectively expanding the treatment window.

Key developments during the reporting period

• In March 2023, the first patient administration was completed in the Chinese phase Ia/Ib clinical study of jSKN003 to treat advanced solid tumors. Later, the clinical study was further approved by the ethics committee of its team leader unit and adjusted to a phase I/II clinical study.
• As of October 26, 2023, JSKN003 showed initial efficacy and good tolerability in patients with HER2-expressing solid tumors in a phase I clinical study conducted in Australia. The relevant data was released in the form of an announcement on November 16, 2023.
• In December 2023, the first patient administration was completed in the phase III clinical study of JSKN003 to treat advanced HER2 low expression breast cancer.

Expected milestones for 2024

• Two additional registered clinical studies were added.
• JSKN003 Australian Phase Ia (dose escalation phase) clinical study data for the treatment of advanced solid tumors expressing HER2 was presented at the American Association for Cancer Research (AACR) annual meeting in April 2024.
• Some data from the JSKN003 Australian Phase I Clinical Study and the Chinese Phase I/II Clinical Study are expected to be released at the ASCO Annual Meeting in June 2024.
• Breast cancer data from the JSKN003 Australian Phase I clinical study and the Chinese Phase I/II clinical study are expected to be released in SABCS in December 2024.

KN035 (Envolimab, Envida)

An innovative anti-tumor immunotherapy drug. It is the world's first and currently the only subcutaneous PD-L1 inhibitor approved for marketing. It is also the first immunotherapy drug for cross-tumor indications in China, and the first domestically produced PD-L1 drug. It has the advantages of effectiveness, safety, convenience, compliance, and lower medical costs. KN035 is undergoing a number of key clinical studies in China and the US.

Key developments during the reporting period

• In June 2023, partner TRACON Pharmaceuticals, Inc. announced the positive results of a six-month independent data monitoring committee review of the EnvasArc phase II key clinical study conducted by KN035 in the US.
• In August 2023, the IND phase III clinical study of KN035 for new adjuvant/adjuvant treatment for patients with non-small cell lung cancer was approved by the National Drug Administration, and the first patient administration was completed in December 2023.
• In October 2023, the IND phase III clinical study of KN035 combined with lenvatinib versus carboplatin-paclitaxel chemotherapy for first-line treatment of patients with advanced or recurrent mismatch repair (pMMR) endometrial cancer was approved by the US Food and Drug Administration (FDA).
• In November 2023, KN035 combined with lenvatinib was recognized as a breakthrough therapy by CDE of the China Drug Administration for the treatment of advanced non-microsatellite highly unstable (MSI-H) /non-mismatch repair genetically defective (dMMR) at least first-line platinum-containing chemotherapy.

Progress after the reporting period

• Corning Jerry and 3D Medicines reached an agreement with Glenmark on KN035 to grant Glenmark exclusive licensing rights to develop and commercialize oncology indications in India, Asia Pacific (excluding Singapore, Thailand, and Malaysia), the Middle East and Africa, Russia, the CIS, and Latin America. Glenmark is responsible for the development and commercialization of the KN035, and Corning Jerry reserves the exclusive right to produce the KN035 for any purpose within or outside the region.

JSKN033

A combination preparation for subcutaneous injection composed of JSKN003 and envolizumab.

• In December 2023, the phase I/II clinical study of jskn033 for the treatment of advanced HER2 expression or metastatic solid tumors was approved by the BellBerry Clinical Research Ethics Committee in Australia. The first patient administration was completed in March 2024.
• The Australian Phase I clinical study dose climbing phase is expected to be completed in 2024.

JSKN016

A dual anti-ADC targeting HER3 and TROP2 can induce death of TROP2 or HER3-positive tumor cells.

• The clinical research application for JSKN016 for the treatment of advanced malignant solid tumors was approved by the CDE of the State Drug Administration in March 2024, and phase I clinical research will be carried out in China.

KN052

An innovative PD-L1/OX40 bispecific antibody can simultaneously bind PD-L1 and OX40, effectively reverse tumor-induced immunosuppression by blocking the PD-L1/PD-1 pathway, and promote immune response by stimulating OX40.

• In February 2023, a strategic partnership was established with Siwei (Shanghai) Biotechnology Co., Ltd. to focus on clinical research and development cooperation for bispecific antibody drugs (KN052) and mRNA vaccine drugs in the field of oncology.
• In April 2023, the KN052 preclinical study results were first announced at the 2023 American Association for Cancer Research (AACR) Late-Breaking Research. Preclinical studies have shown that KN052 has acceptable pharmacokinetics and safety, and its anti-tumor activity is significantly stronger than that of the two single-target control antibodies alone and in combination.

KN019

An immunosuppressant fusion protein based on CTLA-4 has potential wide application in autoimmune diseases and immune disorders caused by tumor immunotherapy.

• In November 2023, the subcutaneous formulation of KN019 received IND approval from the State Drug Administration for clinical development.

II. Production base

The company's drug development and industrialization base covers an area of 75 acres. The production line is equipped with world-class equipment that complies with the relevant GMP regulations of the China National Drug Administration, FDA and the European Medicines Administration. Currently, it has production lines for various engineered antibody drugs, including ADC. The production scale of the original solution has reached 12,000 L, and the annual production capacity of the formulation exceeds 2.8 million, providing safe, effective, and affordable innovative drugs for cancer patients. 2024 will promote the upgrading of ADC drug development and production processes.

III. Other Summaries

In November 2023, Corning Jerry was selected as one of the “Top 100 Innovative Chinese Pharmaceutical Companies” and the “Top 20 ESG Competitiveness of Listed Chinese Pharmaceutical Companies”.

For more information on the above, please refer to the Company's publication on the Hong Kong Stock Exchange and the company's official website2023 results announcement.

About Corning Jerry

Corning Jerry is an innovative biopharmaceutical company dedicated to the discovery, development, production and commercialization of world-class anti-tumor drugs to provide patients with innovative biologic therapies. On December 12, 2019, the company was listed on the main board of the Hong Kong Stock Exchange (stock code: 9966.HK).

Corning Jerry has created a biomacromolecular drug development and production technology platform with independent intellectual property rights, such as protein/antibody engineering, antibody screening, and multi-module/multifunctional antibody modification. A product pipeline with significant differentiation advantages and strong international competitiveness has been created, covering innovative anti-tumor drugs such as single-domain antibody/monoclonal antibodies, multi-functional antibodies and antibody conjugates: 1 product is KN035 (the world's first subcutaneous PD- (L) 1 inhibitor, Envolimab injection, product name: Envida) It was approved for marketing in China in 2021 and has become a widely accessible drug for cancer patients; 3 products are in advanced clinical development; HER2 dual antibody KN026 has been recognized as a breakthrough therapy by the Chinese NMPA. In addition, the company has a rich early development pipeline, and 2 new drug molecules have already entered the clinical research stage.

“Kangda patients, Regis family”. Corning Jerry has always focused on unmet clinical needs and continues to develop safe, affordable, and globally competitive anti-tumor drugs to benefit patients.