The board of directors of SciClone Pharmaceuticals (Holdings) Limited announced that the Company and Berlin-Chemie AG, Menarini Group ("Menarini"), have entered into a license and collaboration agreement (the "License Agreement") granting the Group the exclusive right to develop and commercialize Orserdu® (Elacestrant) ("Orserdu®") in China, under Menarini's head license agreement with Radius Health Inc. ("Radius"). Orserdu ® is the "first and only" treatment specifically indicated for patients with ESR1 mutations in ER+, HER2- advanced or metastatic breast cancer ("mBC") with the approval from the U.S. Food and Drug Administration ("FDA") under its priority review and fast track designation in January 2023, and subsequently from the European Commission in September 2023. The transaction contemplated under the License Agreement aims to bring this innovative treatment to China, pending local regulatory approval.

Breast cancer has overtaken lung cancer as the world's mostly commonly-diagnosed cancer and China accounted for 18% of the total number of new breast cancer cases worldwide, according to statistics released by the International Agency for Research on Cancer of World Health Organization in December 2020. Approximately 70% of breast cancer cases are HR+, HER2- and up to 40% of ER+, HER2- advanced or mBC cases present with ESR1 mutations. Sequential endocrine therapy ("ET") is considered the mainstay treatment for premenopausal and postmenopausal women with HR+/HER2- mBC without extensive visceral involvement.

However, ESR1 mutations are a known driver of resistance to standard ET, and so far, have been difficult to treat. Orserdu®, an oral selective estrogen receptor degrader ("SERD") developed as a once-daily treatment for ER+, HER2- tumors that harbor ESR1 mutations, represents the first innovation in ET in nearly 20 years. The approval of Orserdu® by the FDA and European Commission is supported by data from a Phase 3 trial called EMERALD, which demonstrated statistically significant progression-free survival ("PFS") with Orserdu ® versus standard-of-care ("SOC"), defined as investigator's choice of an approved endocrine monotherapy.

The primary endpoints of the study were PFS in the overall patient population and in patients with ESR1 mutations. In the group of patients whose tumors had ESR1 mutations, Orserdu® achieved a median PFS of 3.8 months versus 1.9 months on the SOC, and reduced the risk of progression or death by 45% (PFS HR=0.55, 95% CI: 0.39, 0.77) versus SOC. A post hoc subgroup analysis of the EMERALD PFS results, which was presented at the San Antonio Breast Cancer Symposium 2022, demonstrated that the duration of prior CDK4/6i treatment was positively associated with longer PFS on Orserdu® but not with SOC.

For patients with ESR1 mutations who were treated with CDK4/6i for 12 months prior to randomization on EMERALD, Orserdu® achieved a median PFS of 8.6 months versus 1.9 months on SOC, with a 59% reduction in the risk of progression or death (HR=0.41 95% CI: 0.26­0.63). Under the License Agreement, SciClone will utilize its development capability to proceed with clinical trials and employ its sales, marketing and regulatory expertise to distribute Orserdu®, upon approval in China. SciClone will pay Menarini an upfront fee in cash and make additional payments upon various regulatory and sales milestones.

Menarini will also be eligible to receive tiered royalties based on net sales of Orserdu® in China.