Organon Enters into Global License Agreement to Commercialize Henlius’ Investigational Perjeta® (Pertuzumab) and Prolia®/Xgeva® (Denosumab) Biosimilar Candidates

Collaboration expands and underscores commitment to biosimilars portfolio and focus on women’s health with biosimilar candidates for osteoporosis and breast cancer

JERSEY CITY, NJ, USA I June 13, 2022 I Organon (NYSE: OGN), a global women’s health company with deep expertise in biosimilar commercialization, today announced that it has entered into an agreement with Shanghai Henlius Biotech, Inc. (2696.HK), whereby Organon will license commercialization rights for biosimilar candidates referencing Perjeta® (pertuzumab, HLX11) and Prolia®/Xgeva® (denosumab, HLX14). Organon will acquire exclusive global commercialization rights except for China; including Hong Kong, Macau and Taiwan.

Pertuzumab is used for the treatment of certain patients with HER2+ breast cancer in combinations with trastuzumab and chemotherapy. In the US, 20% of people with breast cancer are HER2+. Denosumab is used for the treatment of certain patients with osteoporosis with high risk of fracture and for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastasis from solid tumors. Osteoporosis affects over 20% of women over the age of 50 globally.

“Biosimilars are a key growth pillar for Organon, and this collaboration represents the successful execution of our strategy to expand our biosimilars portfolio leveraging our strong global footprint and deep commercial expertise,” said Kevin Ali, CEO of Organon. “With our experience in biosimilars and women’s health, our goal is to help more patients gain access to treatments for breast cancer and osteoporosis, two areas that significantly impact the health of women.”

The agreement also includes an option to negotiate an exclusive license for global commercialization rights for a biosimilar candidate referencing Yervoy ® (ipilimumab, HLX13). Ipilimumab is used for the treatment of certain patients with unresectable or metastatic melanoma, as adjuvant treatment of certain patients with cutaneous melanoma, certain patients with Renal Cell Carcinoma, Colorectal Cancer, Hepatocellular Carcinoma, Non-Small Cell Lung Cancer, Malignant Pleural Mesothelioma and Esophageal Cancer.

Consideration for the transaction includes an upfront payment of $73 million as well as additional payments upon the achievement of certain development, regulatory and commercial milestones. Henlius will be responsible for development and, if approved, will supply the products to Organon.

As stated on Organon’s first quarter conference call, to align with views expressed by the US Securities and Exchange Commission, beginning in 2022 Organon will no longer exclude expenses for upfront and milestone payments related to collaborations and licensing agreements, or charges related to pre-approval assets obtained in transactions accounted for as asset acquisitions, from its non-GAAP results. Organon’s financial guidance does not assume an estimate for these expenses associated with business development not yet executed, and accordingly, the $73 million upfront payment and an approximate $30 million for milestones expected to be achieved in 2022 were not included in the full year 2022 guidance the company provided on May 5, 2022. The company does not plan to update its guidance inter-quarter based solely on these items.

About HLX11 (pertuzumab biosimilar candidate)

HLX11 (anti-HER2 domain II humanized monoclonal antibody injection) is a biosimilar candidate of pertuzumab and is independently developed by Henlius. Pertuzumab is used in combination with trastuzumab and chemotherapy as neoadjuvant or adjuvant treatment for HER2 positive early breast cancer and in combination with trastuzumab and docetaxel in certain patients with HER2 positive metastatic or unresectable locally recurrent breast cancer. To date, HLX11 has met the primary endpoint in a Phase 1 clinical trial, showing similar pharmacokinetic and safety profiles to the reference drugs from different sources.

About HLX14 (denosumab biosimilar candidate)

HLX14 (recombinant anti-RANKL human monoclonal antibody injection) is a biosimilar candidate of denosumab and is independently developed by Henlius. Denosumab is used for a range of indications including for the treatment of postmenopausal women with osteoporosis at high risk for fracture, certain patients with giant cell tumor of bone, and skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors.

About Organon

Organon is a global healthcare company formed to focus on improving the health of women throughout their lives. Organon has a portfolio of more than 60 medicines and products across a range of therapeutic areas. Led by the women’s health portfolio coupled with an expanding biosimilars business and stable franchise of established medicines, Organon’s products produce strong cash flows that will support investments in innovation and future growth opportunities in women’s health. In addition, Organon is pursuing opportunities to collaborate with biopharmaceutical innovators looking to commercialize their products by leveraging its scale and presence in fast growing international markets.

Organon has a global footprint with significant scale and geographic reach, world-class commercial capabilities, and approximately 9,300 employees with headquarters located in Jersey City, New Jersey.

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About Henlius

Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. Up to date, 5 products have been launched in China, 1 in Europe, 13 indications approved worldwide, and 2 New Drug Application (NDA) accepted for review in China. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centers and a Shanghai-based manufacturing facility certificated by China and the EU Good Manufacturing Practice (GMP).

Henlius has pro-actively built a diversified and high-quality product pipeline covering over 20 innovative monoclonal antibodies (mAbs) and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as backbone. Apart from the launched products HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, Zercepac® in Europe), the first China-developed mAb biosimilar approved both in China and Europe, HANDAYUAN (adalimumab) and HANBEITAI (bevacizumab), the innovative product HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumors and its NDA for the treatment of squamous non-small cell lung cancer and extensive small-cell lung cancer (ES-SCLC) are under review. What's more, Henlius has conducted over 20 clinical studies for 12 products and 10 combination therapies.

SOURCE: Organon

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