Alphamab Biopharma and 3DMedicines Entered into a Licensing Agreement with Glenmark for KN035

2024-01-25

Alphamab Biopharma and 3DMedicines announced that we entered into a license agreement with Glenmark Specialty S.A. a subsidiary of Glenmark Pharmaceuticals Ltd. for the subcutaneous injection PD-L1 antibody drug (R&D code: KN035), pursuant to which, Glenmark was granted exclusive licensing interests in clinical development and commercialization of oncology indications in India, Asia Pacific(except Singapore, Thailand, Malaysia), the Middle East and Africa, Russia, CIS and Latin America.

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Transaction Overview
Transaction Overview

  • Alphamab Biopharma, 3D Medicines and Glenmark announce the signing of a license agreement for Envafolimab for multiple geographies around the World. 
    Corning Jerry and Sidodi Pharmaceuticals jointly announced the granting of Glenmark exclusive rights for the development and commercialization of the subcutaneous PD-L1 antibody drug Envida (generic name: Envokimab Injection) for tumor indications in multiple regions worldwide.
  • Alphamab BioPharma (on behalf of the Licensors) will receive a total of $700.8 million from Glenmark consisting of non-refundable upfront payments and milestone payments based on sales performance across the length of the agreement, and a royalty fee of single-to-double-digits percentage according to the level of net sales.
    Corning Jerry (representing the licensor) will receive a total of $700.8 million from Glenmark, including a non-refundable upfront payment and milestone payments based on the development, commercialization progress, and sales performance of Envafolimab, and will receive royalties ranging from single-digit to double-digit percentages on Envafolimab's net sales.
  • YAFO Capital (Shanghai) acted as transaction advisor on this transaction for Alphamab Biopharma.
    Yafa serves as a trading advisor for Corning Jerry.

January 25, 2024: JIANGSU ALPHAMAB BIOPHARMACEUTICALS CO., LTD (Alphamab BioPharma) and 3D MEDICINES (BEIJING) CO., LTD. (3DMed), (together as the Licensors) today announced the signing of a license agreement with Glenmark Specialty S.A. (GSSA), a subsidiary of Glenmark Pharmaceuticals Ltd. (Glenmark) for KN035 (Envafolimab) for India, Asia Pacific, Middle East and Africa, Russia, CIS, and Latin America (the Territory). 
On January 25, 2024, Kangning Jierui Biopharmaceutical (Stock Code: 9966.HK) and SIRD Pharmaceuticals (Stock Code: 1244.HK) (collectively referred to as the "Licensors") jointly announced that they have reached an agreement with Glenmark regarding the subcutaneous PD-L1 antibody drug Envinda® (research code: KN035, generic name: Envolimab Injection), granting Glenmark exclusive licensing rights for the development and commercialization of oncology indications in India, the Asia-Pacific region (excluding Singapore, Thailand, and Malaysia), the Middle East and Africa, Russia, the CIS, and Latin America. Glenmark will bear all costs related to the development and commercialization of Envolimab.

Under the terms of the agreement, Alphamab BioPharma will be the exclusive supplier of the product. Alphamab BioPharma (on behalf of the Licensors) will receive a total of $700.8 million from Glenmark, consisting of non-refundable upfront payments and milestone payments based on the development, commercialization progress, and sales performance of Envafolimab, and a royalty fee ranging from single-digit to double-digit percentages according to the level of net sales of Envafolimab. Each Licensor's right to receive payments (including upfront payments, milestone payments, and royalties) under the license agreement shall be subject to the agreement between Sorridi Pharma and Jiangsu Kangning Jerry. Kangning Jerry retains the exclusive global right to manufacture Envafolimab for any purpose. Sorridi Pharma retains global development rights for any purpose in the oncology field outside the scope of the granted license.

Dr. Ting Xu, Chairman and President of Alphamab BioPharma, said, "This collaboration is very important for the further development of Envolimab. Based on Glenmark's development and commercialization capabilities, we believe Envolizumab will benefit a large number of cancer patients in the cooperation area." Envolizumab's advantages in safety, convenience and compliance make it a competitive product, and we look forward to a successful collaboration."
Dr. Xu Ting, Chairman and CEO of Corning Jerry, said: 'This cooperation is very important for the further development of Envafolimab. Based on Glenmark's development and commercialization capabilities, we believe that Envafolimab will benefit a large number of cancer patients in the regions covered by the collaboration. The advantages of Envafolimab in terms of safety, convenience, and compliance make it a competitive product, and we look forward to the success of this cooperation.'

Dr. Zhaolong Gong, Chairman and CEO of 3D Medicines, said: "We are very excited to see that Envolizumab can help more cancer patients, and this collaboration is good news for cancer patients in emerging markets. Patients in emerging markets demand more convenient and innovative treatments. I hope we can work together to serve more cancer patients and help them live longer and better."
Dr. Gong Zhaolong, Chairman and CEO of 3D Medicines, said: 'We are very pleased to see Envouli can help more cancer patients. This cooperation is important good news for a large number of cancer patients in emerging markets. Patients in emerging markets need more convenient and innovative treatment drugs. We hope to work together to serve more cancer patients and help them live longer and better.'

“This is an important milestone for Glenmark, as through this transformational deal, we gain access to the first recombinant humanized single domain antibody against PD-L1 in a Sub-Q formulation for a wide territory globally. We are excited at the opportunity to take this innovative immuno-oncology product to cancer patients across the emerging markets and meaningfully contribute towards improving their access to potentially life-saving treatments.” remarked Glenn Saldanha, Chairman & Managing Director, Glenmark Pharmaceuticals Ltd. 
Glenmark Chairman and Managing Director Glenn Saldanha stated: "This collaboration is an important milestone for Glenmark. Through this deal, we have acquired the regional commercialization rights for the world’s first subcutaneously administered PD-L1 recombinant humanized single-domain antibody. We look forward to introducing this innovative product, making a positive contribution to the field of cancer immunotherapy, and helping cancer patients in emerging markets."

YAFO Capital (Shanghai) acted as transaction advisor on this transaction for Alphamab Biopharma.
Ya Fa Capital (Shanghai) serves as the transaction advisor for Corning Jerry in this cooperation.

About KN035 (Envafolimab Injectable) (brand name: ENWEIDA, 恩維達®)
About Envida® (Envafolimab Injection)

KN035 (Envafolimab Injectable) is a recombinant single domain antibody against PD-L1 fused with human Fc, a drug independently invented by Alphamab Oncology and co-developed with 3DMed Beijing since 2016. On December 20, 2019, TRACON Pharmaceuticals, Inc., the shares of which are listed on the Nasdaq Global Select Market (ticker symbol: TCON), was granted the exclusive and nontransferable license in the U.S., Canada, Mexico and each of their dependent territories for KN035 in the field of human therapeutic applications for sarcoma. On March 30, 2020, Alphamab BioPharma, a wholly owned subsidiary of Alphamab Oncology, Jiangsu Simcere Pharmaceutical Co., Ltd.* (江蘇先聲藥業有限公司) (“Jiangsu Simcere”), a subsidiary of Simcere Pharmaceutical Group Limited, the shares of which are listed on the Stock Exchange (stock code: 2096), and 3DMed Beijing entered into a cooperation agreement (the “Simcere Agreement”). Pursuant to the Simcere Agreement, Jiangsu Simcere has been granted an exclusive marketing right in respect of oncology indications of KN035 and the rights of first refusal for in-licenses or transfers in mainland China. And it has been approved by the National Medical Products Administration of China (國家藥品監督管理局) as the global-first subcutaneous injection PD-L1 inhibitor in November 2021.
Enweida® (Envafolimab Injection) was independently developed by Conning Jerry, and since 2016, it has been co-developed with Slordi Pharmaceutical. On March 30, 2020, Conning Jerry, Slordi Pharmaceutical, and Simcere Pharmaceutical reached a strategic cooperation agreement, with Conning Jerry responsible for production and quality as the original developer, Slordi Pharmaceutical responsible for clinical development and commercialization in the oncology field, and Simcere Pharmaceutical responsible for exclusive commercial promotion of the product in mainland China. Due to its unique design, Enweida® has advantages in efficacy, safety, convenience, and compliance; patients do not need intravenous infusion, and it is expected to reduce medical costs. Currently, clinical trials for multiple tumor indications are being conducted simultaneously in China, the United States, and Japan, with several indications having entered registration/Phase III clinical trials. Enweida® has been granted orphan drug status by the U.S. FDA for advanced cholangiocarcinoma and soft tissue sarcoma. In November 2021, Enweida® was officially approved for marketing in China, being the first in the country, and is indicated for the treatment of adult patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) advanced solid tumors, including patients with advanced colorectal cancer who have experienced disease progression after previous treatment with fluoropyrimidines, oxaliplatin, and irinotecan, as well as other advanced solid tumor patients who have experienced disease progression after prior treatment and have no satisfactory alternative treatment options.

About Alphamab Biopharma
About Corning Jerry

Alphamab Biopharma is a leading biopharmaceutical company committed to the discovery, development, manufacturing, and commercialization of cutting-edge biotherapeutics for the treatment of cancer. On December 12, 2019, the company was successfully listed on the Main Board of the Hong Kong Stock Exchange, trading under the stock code 9966.Their integrated platform seamlessly combines research, development, and manufacturing capabilities for biologics. Distinguished by a globally competitive pipeline, Alphamab Biopharma specializes in antibody-drug conjugation, single domain antibody/monoclonal antibodies, and multi-functional antibodies.
For more information, please visit https://www.alphamabonc.com/
Corning Jerey is an innovative biopharmaceutical company dedicated to discovering, developing, manufacturing, and commercializing world-class anti-tumor drugs to provide patients with innovative biological therapies. On December 12, 2019, the company was listed on the Main Board of the Hong Kong Stock Exchange (stock code: 9966.HK). Corning Jerey has established proprietary technology platforms for the research and development and production of biologic drugs, including protein/antibody engineering, antibody screening, multi-module/multi-functional antibody modification. The company has built a product pipeline with significant differentiated advantages and strong international competitiveness, covering innovative anti-tumor drugs such as single-domain antibodies/monoclonal antibodies, multifunctional antibodies, and antibody-drug conjugates: among them, one product, KN035 (the world's first subcutaneous PD-(L)1 inhibitor, Envoylimab Injection, brand name: Envida®), was approved for marketing in China in 2021, making it widely accessible to cancer patients; three products are in the late clinical development stage; the HER2 bispecific antibody KN026 has been granted breakthrough therapy designation by the NMPA in China. Additionally, the company has a rich early-stage R&D pipeline, with two new drug molecules already in clinical research stages.
更多信息请访问https://www.alphamabonc.com/

About 3D Medicines, inc.
About 3D Medicines

3D Medicines, Inc. is a commercial-stage biopharmaceutical company. Envisioning a future when cancer is managed as a chronic disease, 3D Medicines has established a pipeline with both biological macromolecule and chemotherapeutic small-molecule drugs, as well as a professional team capable of global development, registration and commercialization operation.
For more information, please visit https://www.3d-medicines.com/
3D Medicines Inc. is an innovative pharmaceutical company focusing on oncology that has entered the commercialization stage. On December 15, 2022, the company was officially listed on the Main Board of the Hong Kong Stock Exchange (stock code: 1244). The company's product line includes 12 innovative drugs with clinical value, 8 of which have entered clinical development or commercialization stages, including the subcutaneous PD-L1 single-domain antibody new drug Envida, which has been approved for sale by the National Medical Products Administration (NMPA), with multiple indications recognized as orphan drugs or receiving priority review by the FDA and NMPA.
更多信息请访问https://www.3d-medicines.com/

About Glenmark Pharmaceuticals Ltd.
关于Glenmark

Glenmark Pharmaceuticals Ltd. (BSE: 532296 | NSE: GLENMARK) is a research-led, global pharmaceutical company, having a presence across Branded, Generics, and OTC segments; with a focus on therapeutic areas of respiratory, dermatology and oncology. The company has 10 world-class manufacturing facilities spread across 4 continents, and operations in over 80 countries.
For more information, please visit https://glenmarkpharma.com/
Glenmark (BSE: 532296 | NSE: GLENMARK) is a research-driven global pharmaceutical company, with businesses in innovator drugs, generics, and over-the-counter drugs; focusing on therapies for respiratory, dermatology, and oncology areas. The company has 10 world-class manufacturing facilities across four continents and operates in more than 80 countries.
更多信息请访问https://glenmarkpharma.com/

About YAFO Capital
About YAFO Capital

Founded in 2013, YAFO Capital is a Shanghai based boutique investment and advisory firm, with professional team in our China, U.S., and London offices. YAFO Life Sciences is a leading advisory boutique focused on asset transactions. YAFO has built a strong proven track record and closed dozens of in-licensing and out-licensing transactions with global pharma and biotech companies. YAFO has been ranked as the No. 1 advisor for China cross border licensing transactions in the past four years.
For more information, please visit www.yafocapital.com
YAFO Life Sciences is the healthcare and life sciences division of YAFO Capital. It focuses on assisting overseas pharmaceutical companies with a "China perspective" in China with licensing, strategic cooperation, and financing; as well as providing Chinese innovative drug companies with opportunities for overseas market licensing, overseas market consulting, and sourcing and introducing overseas targets. We are committed to being a bridge connecting global medical technology with the Chinese market and capital. Currently, there are more than thirty senior overseas partners, deeply covering global medical innovation regions such as the United States, Europe, Japan, and South Korea.
For more information, please visit www.yafocapital.com

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参考:https://www.prnewswire.com/apac/news-releases/alphamab-oncology-and-3dmedicines-entered-into-a-licensing-agreement-with-glenmark-for-kn035-302044003.html