SuZhou August 16, 2024 / PRNewswire / -- Corning Jerry Biopharmaceuticals (stock code: 9966.HK) announced its mid-term performance and recent business progress as of June 30, 2024.

Financial Overview

• In the first half of 2024, the company achieved revenue of 173.56 million yuan, a year-on-year increase of 27.18%.
• In the first half of 2024, product revenue was 90.64 million yuan, a year-on-year decrease of 22.54%.
• In the first half of 2024, R&D expenses were 194.53 million yuan, basically flat year-on-year.
• During the first half of 2024, the loss was 44.9 million yuan, and the loss excluding the impact of exchange gains and losses was 52.19 million yuan, a year-on-year decrease of 41.17%.
• The financial position is solid, with cash reserves of 1,456.59 million yuan as of June 30, 2024.

Business Summary

I. Product Pipeline

The company has significantly differentiated and internationally competitive product pipelines that cover anti-tumor new drugs such as single-domain antibodies, multifunctional antibodies, and antibody-drug conjugates (ADCs). One product, KN035 (the world's first subcutaneous injection of PD-(L)1 inhibitor, Envold monoclonal injection, trade name: Envida), was approved for marketing in China in 2021, making a major breakthrough in the convenience and accessibility of cancer treatment; three new drug varieties are undergoing Phase III or critical clinical studies, and multiple new drug varieties are also in clinical stages.

KN046

A bispecific antibody (BsAb) immune checkpoint inhibitor targeting two clinically validated immune checkpoints, PD-L1 and CTLA-4, is a new generation of potential breakthrough tumor immunotherapeutic drug. KN046 has been studied in multiple clinical studies, including non-small cell lung cancer, in China, the United States and Australia in different stages.

Major progress during the reporting period

• In February 2024, the results of the Phase II clinical trial of KN046 combined with albumin-bound paclitaxel for first-line treatment of advanced triple-negative breast cancer were published in full in Nature Communications.
• In March 2024, the results of the Phase II clinical trial of KN046 combined with chemotherapy for first-line treatment of metastatic non-small cell lung cancer were published in full in the cell journal Cell Reports Medicine.

KN026

A new generation of HER2 bispecific antibodies, which can bind to two different HER2 epitopes simultaneously and have good efficacy. Currently, multiple registration clinical studies for indications such as breast cancer, gastric cancer/gastric-esophageal junction cancer are underway, and KN026 combined with chemotherapy for first-line standard treatment failure of HER2-positive gastric cancer (including gastric-esophageal junction adenocarcinoma) has been granted breakthrough therapy recognition by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA).

JSKN003 is a novel antibody-drug conjugate (ADC) targeting HER2 dual sites, independently developed with a unique glycan site-specific conjugation platform by Concorde Jerry. JSKN003 binds to HER2 on the surface of tumor cells and exerts anti-tumor effects by HER2-mediated intracellular release of topoisomerase I inhibitors. Preclinical studies have shown that JSKN003 has better serum stability, stronger bystander killing effect, and equivalent tumor killing activity than similar drugs, effectively expanding the treatment window. At present, multiple clinical studies of JSKN003 are being smoothly conducted in Australia and China, and the key clinical studies of treating advanced HER2-low-expressed breast cancer in China are also actively promoted.

An HER2 bispecific ADC developed using Corning Jerry's unique glycosylation site-specific coupling platform has better serum stability, stronger bystander killing efficacy than similar ADC drugs, and effectively expands the treatment window. At present, JSKN003 is smoothly carrying out multiple clinical studies in Australia and China, and the critical clinical study of treating advanced HER2-low-expressing breast cancer in China is also actively advancing.

Major progress during the reporting period

• In April 2024, JSKN003 the Australian Phase I clinical trial data was published at the American Association for Cancer Research (AACR) annual meeting. The study showed that JSKN003 has good tolerability and safety in patients with advanced/metastatic solid tumors who have undergone multiple lines of therapy, with an extremely low incidence of hematological toxicity among all-grade treatment-related adverse events (TRAEs), and no TRAEs leading to death or discontinuation of treatment; and showed encouraging preliminary anti-tumor activity.
• In June 2024, the first-phase clinical trial data of JSKN003 in China was released at the American Society of Clinical Oncology (ASCO) annual meeting, showing that the ORR of JSKN003 was 51.1% in patients with HER2-positive and HER2-low expression. Among them, the ORR of 28 patients who had received previous anti-HER2 treatment was 57.1%, and the ORR of 21 patients who had received previous anti-HER2 ADC treatment was 57.1%, indicating that the benefits of efficacy were still observed in the population previously treated with ADC.

Post-report period progress

• In July 2024, the latest clinical trial data of JSKN003 for the treatment of platinum-resistant ovarian cancer and advanced HER2-positive solid tumors were accepted by the European Society for Medical Oncology (ESMO) and will be released during the September conference period.

KN035 (envolimab, envita)

An innovative anti-tumor immune therapy drug, the world's first and currently the only subcutaneous injection PD-(L)1 inhibitor approved for marketing, is also the first domestically produced PD-L1 drug for immuno-therapy diseases, and has advantages in effectiveness, safety, convenience, compliance, and greatly saves medical resources.

Major progress during the reporting period

• In January 2024, envolimab was registered and listed with the Macao Special Administrative Region's drug administration for the treatment of unresectable or metastatic microsatellite-high instability (MSI-H) or mismatch repair gene defect type (dMMR) adult advanced solid tumors.
• In January 2024, CorningJerry and 3D Medicines reached an agreement with Glenmark for the exclusive licensing rights to develop and commercialize tumor indications of KN035 in India, Asia-Pacific (except Singapore, Thailand, Malaysia), Middle East and Africa, Russia, Confederation of Independent states and Latin America. Glenmark is responsible for the development and commercialization costs of KN035, and CorningJerry reserves the exclusive right to produce KN035 for any purpose inside and outside the region.
• In March 2024, envolimab was included in the 2024 Chinese expert consensus on the use of immune checkpoint inhibitors for preoperative treatment of advanced gastric cancer released by the Chinese Anti-Cancer Association Gastric Cancer Committee. So far, envolimab has been recommended in 15 latest authoritative clinical guidelines and consensuses at home and abroad.

Post-report period progress

• In July 2024, the supplementary application for KN035 site, scale and process change was approved, and GMP compliance inspections are currently underway.
• In August 2024, envolimab was included in the list of breakthrough therapeutic drug varieties by the CDE of the National Medical Products Administration for the treatment of unresectable or metastatic tumor with high tumor mutation burden (TMB-H) that has failed standard treatment and has no satisfactory alternative therapy.

JSKN033

A high-concentration subcutaneous injection compound preparation of the world's first antibody-conjugate drug and immune checkpoint inhibitor developed independently by CorningJerry. JSKN033 combines immune therapy (KN035) with ADC (JSKN003) to greatly enhance efficacy; takes advantage of the stability and high solubility of envolimab to allow ADC to be administered subcutaneously, improving safety and convenience.

Major progress during the reporting period

• In March 2024, the phase I/II clinical trial of JSKN033 for the treatment of advanced or metastatic solid tumors with HER2 expression completed the first patient dosing in Australia.

JSKN016

A bispecific ADC targeting HER3 and TROP2 using a unique glycosylation site-specific coupling platform developed independently by CorningJerry. JSKN016 can kill tumor cells that are HER3 and/or TROP2 positive, and has bystander killing effects and potential therapeutic effects for multiple solid tumors.

Major progress during the reporting period

• In March 2024, the phase I IND application of JSKN016 for the treatment of advanced malignant solid tumors was approved by the National Medical Products Administration, and the first patient dosing was completed in May 2024.

KN019

A CTLA-4-based immune suppressant fusion protein has potential for widespread use in autoimmune diseases and immune imbalance caused by tumor immunotherapy. The subcutaneous injection formulation was approved by the National Medical Products Administration's IND in November 2023 for clinical development.

II. Technology Platform The company has a complete proprietary technology platform in bispecific antibodies, multifunctional protein engineering, and ADCs, which can provide safe and effective innovative drugs for patients.

On June 2024, Jiangsu Koning Jerui and ArriVent BioPharma, Inc. signed a research and commercialization agreement, in which both parties will use Coning Jerui's proprietary linker payload platform (Alphatecan) and glycomic site-specific conjugation platform to discover and develop new ADCs.

III. Production Base The company's industrialization base is built in accordance with the GMP standards of the National Medical Products Administration (NMPA), the US Food and Drug Administration (FDA), and the European Medicines Agency (EMA). The production line is equipped with internationally leading equipment and facilities to support the production of various biomolecular drugs, including ADCs. The new ADC bulk liquid and formulation workshop has started construction.

Dr. Xu Ting, chairman and president of Koning Jerui, said:" The past six months have been very difficult for us because KN046-303 did not reach its endpoint, but now we should summarize our experience and continue to move forward." Here are some highlights I'd like to share: we will continue to promote the registered clinical research of JSKN003 and obtain the efficacy and safety data of JSKN016 and JSKN033, as well as develop more new preclinical candidate drugs. At the same time, after the significant decline in product revenue of Envolimab in the second half of 2023, we have seen a positive trend in restart. In addition, our collaboration with CSPC Pharma on KN026 has made significant progress in both registered clinical research. Finally, clinical exploration of KN046 in non-small cell lung cancer is still ongoing.

Thank you to the team, thank you to the board of directors and shareholders for their trust and continued support." For more information on the above, please refer to the company's interim performance announcement for the six months ended June 30, 2024, published on the Hong Kong Stock Exchange and the company's official website.

More technical details can be found in the company's statement on its official website and public releases on HKEX.
Here I share some highlights: we are continuing to advance the registered clinical research of JSKN003, obtain efficacy and safety data of JSKN016 and JSKN033, and develop more new clinical pre-candidate drugs. At the same time, we see that the product revenue of Enbolituzumab has restarted a positive trend after a significant decline in the second half of 2023. Moreover, both registered clinical studies of KN026, which we cooperate with CSPC Pharma, have made significant progress. Finally, the clinical exploration of KN046 for non-small cell lung cancer is still ongoing.
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Director's Report Company Koning Jerui's overall sales in 2023 reached 18,000 kiloliters, a YoY increase of 28.10%, a sign of significant growth. In terms of product structure, the operating income from products valued between 1 billion and 3 billion yuan were 401/1288/60 million yuan respectively.

Concorde Jerry is an innovative biopharmaceutical company committed to discovering, developing, producing and commercializing world-class anti-tumor drugs to provide innovative biological therapies for patients. On December 12, 2019, the company was listed on the main board of the Hong Kong Stock Exchange (stock code: 9966.HK).

CanSino Biologics is an innovative biopharmaceutical company dedicated to the development, production and commercialization of world-class anti-tumor drugs, providing innovative biological therapies for patients. The Company was listed on the main board of the Hong Kong Stock Exchange on December 12, 2019 (stock code: 9966.HK).

CanSino Biologics has established biologics drug development and production technology platforms with independent intellectual property rights, such as protein/antibody engineering, antibody screening, multi-module/multi-functional antibody modification, etc. The Company has built a product pipeline with significant differentiation advantages and international competitiveness, covering innovative anti-tumor drugs such as single-domain antibodies, multi-functional antibodies and antibody conjugates. One of the products, KN035 (the first subcutaneous injection PD-(L)1 inhibitor in the world, envolimab injection, trade name: Envida), has been approved for marketing in China in 2021, making significant breakthroughs in the convenience and accessibility of cancer treatment. Three new drugs are undergoing phase III or pivotal clinical studies, and several new drugs are also in clinical stages.

"We care for patients and strive for global wellness." CanSino Biologics is focused on unmet clinical needs, continuously developing safe and effective, cost-controlled, globally competitive anti-tumor drugs to benefit patients.

Please visit the company's website: