Core Insights - Orogen Royalties Inc. has announced significant updates regarding its partner-funded exploration projects and royalties [1] Group 1: Exploration Activities - The company is engaged in up to 30,000 metres of drilling across seven partner-funded programs located in Nevada, British Columbia, Colombia, and Western Kenya [1] - Over $3.0 million has been allocated for generative exploration targeting copper and gold in the western United States and Canada, in collaboration with partners such as Altius Minerals, Triple Flag Precious Metals, South 32, and BHP [1] Group 2: Project Management - Orogen currently has seven projects under option to industry partners and has sold three projects year-to-date [1] - The company will host its second annual Project Generator Day on October 8, 2025, to showcase recently generated projects [1] Group 3: Company Performance - The CEO of Orogen, Paddy Nicol, stated that this year has been one of the busiest in the company's history for project-level and generative exploration activities [1]

Core Viewpoint - The European Commission has approved two biosimilars of denosumab, BILDYOS and BILPREVDA, developed by Fuhong Hanlin and Organon, marking a significant milestone in expanding treatment options for osteoporosis and related conditions in Europe [1] Group 1: Product Approval - The approval includes BILDYOS (60 mg/mL) and BILPREVDA (120 mg/1.7 mL), which are biosimilars to PROLIA and XGEVA, respectively, covering all indications approved for the original products in the EU [1] - With this approval, Fuhong Hanlin now has a total of four products approved in the EU [1] Group 2: Market Impact - The approval is expected to enhance accessibility to critical bone health treatments for millions of European patients, particularly women who are more affected by osteoporosis [1] - The launch of these biosimilars supports the sustainability of the European healthcare system by providing more treatment options for conditions related to bone loss [1] Group 3: Strategic Partnership - The approval is a result of the collaboration between Fuhong Hanlin and Organon, which signed a licensing and supply agreement in 2022, granting Organon exclusive commercialization rights for these biosimilars outside of China [2]

Core Viewpoint - The European Commission has approved the marketing authorization for two biosimilars of denosumab, BILDYOS® and BILPREVDA®, developed by Fuhong Hanlin in collaboration with Organon, marking a significant milestone in expanding treatment options for osteoporosis and related conditions in Europe [1][2]. Group 1: Product Approval - The approval includes BILDYOS® (60 mg/mL) and BILPREVDA® (120 mg/1.7 mL), which are biosimilars to PROLIA® and XGEVA®, respectively, covering all indications approved for the original products in the EU [1]. - With this approval, Fuhong Hanlin now has a total of four products approved in the EU [1]. Group 2: Market Impact - The approval of BILDYOS and BILPREVDA is expected to enhance accessibility to critical bone health treatments for millions of European patients, particularly women who are more affected by osteoporosis [1]. - The launch of these biosimilars supports the sustainability of the European healthcare system by providing more treatment options for conditions related to bone loss [1]. Group 3: Strategic Partnership - The collaboration between Fuhong Hanlin and Organon, established through a licensing and supply agreement in 2022, grants Organon exclusive commercialization rights for these biosimilars outside of China [2]. - This partnership is seen as a significant achievement in meeting the needs of European patients and healthcare systems [1].

Core Viewpoint - The European Commission has approved Henlius and Organon's biosimilars BILDYOS® and BILPREVDA®, both of which are denosumab products, indicating a significant advancement in the biosimilars market [1] Group 1 - The approval of BILDYOS® and BILPREVDA® represents a strategic move for Henlius and Organon in expanding their product offerings in the biosimilars sector [1] - This approval is expected to enhance competition in the market for denosumab, which is used for conditions such as osteoporosis and certain cancers [1] - The introduction of these biosimilars may lead to cost savings for healthcare systems and patients, promoting greater access to treatment options [1]

Group 1 - Kuehn Law, PLLC is investigating potential breaches of fiduciary duties by certain officers and directors of Organon & Co. related to shareholder interests [1] - A federal securities lawsuit alleges that Organon misled investors regarding its capital allocation strategy, particularly concerning its commitment to quarterly dividends [1] - The lawsuit claims that while Organon stated that capital allocation through dividends was a "1 capital allocation priority," it simultaneously concealed adverse facts about its true priorities [1]

Core Points - Orogen Royalties Inc. has announced that its shares are now qualified to begin trading on the OTCQB Venture Market [1] - The trading commenced under the symbol "OGNNF" on September 8, 2025 [1]

Core Viewpoint - Fuhong Hanlin's stock rose nearly 6% following the FDA approval of two biosimilar products, BILDYOS and BILPREVDA, in collaboration with Organon, enhancing its market position in the U.S. biosimilar sector [1] Group 1: Company Developments - Fuhong Hanlin's stock price increased by 5.78%, reaching 81.45 HKD, with a trading volume of 48.73 million HKD [1] - The FDA approved BILDYOS (denosumab-nxxp) and BILPREVDA (denosumab-nxxp), which are biosimilars to PROLIA and XGEVA, respectively [1] - The approval covers all indications for the original products in the U.S. market [1] Group 2: Partnership and Market Impact - In 2022, Fuhong Hanlin entered into a licensing and supply agreement with Organon, granting Organon exclusive commercialization rights for several biosimilars, including BILDYOS and BILPREVDA, outside of China [1] - The approval of these products strengthens Organon's biosimilar portfolio in the U.S., which has been developed over eight years and spans five major therapeutic areas [1]

Core Viewpoint - Henlius has received FDA approval for two biosimilar products, BILDYOS® and BILPREVDA®, which are biosimilars to PROLIA® and XGEVA®, respectively, covering all indications approved for the original products in the U.S. [1] Group 1 - The FDA approved BILDYOS® (60mg/mL) for five indications, including osteoporosis [3] - The FDA approved BILPREVDA® (120mg/1.7mL) for three indications, including bone-related events [3] - This marks Henlius's third product approved in the U.S. [3] Group 2 - The approval reflects Henlius's commitment to scientific excellence and product quality [1] - The collaboration with Organon aims to enhance the accessibility of high-quality biologics for U.S. patients [1]

Core Viewpoint - The approval of BILDYOS and BILPREVDA by the FDA marks a significant advancement in improving accessibility to critical bone care treatments for millions of Americans, particularly the aging population [1][2] Company Summary - Fuhong Hanlin has successfully developed and produced biosimilars BILDYOS and BILPREVDA, which have received FDA approval, demonstrating the company's commitment to scientific excellence and product quality [1] - The collaboration with Organon aims to expand the accessibility of high-quality biologics, providing patients with treatment options that are equivalent in efficacy and safety to the original drugs [1] Industry Summary - The approval of BILDYOS and BILPREVDA is based on a comprehensive review of data, including structural and functional analyses, pharmacokinetic data, and a clinical comparative study, showing high similarity in safety, purity, and efficacy to the original drugs PROLIA and XGEVA [2] - The approval enhances Organon's portfolio of biosimilars in the U.S., which has been developed over eight years and covers five major therapeutic areas [2]

Core Viewpoint - The approval of BILDYOS and BILPREVDA by the FDA marks a significant advancement in improving accessibility to critical bone care treatments for millions of Americans, particularly the aging population [1][2] Group 1: Product Approval - The FDA has approved two biosimilar products, BILDYOS (denosumab-nxxp) and BILPREVDA (denosumab-nxxp), which are biosimilars to PROLIA and XGEVA, covering all indications previously approved for the original products in the U.S. [1] - The approval is based on a comprehensive review of data, including structural and functional analyses, clinical pharmacokinetics, and a clinical comparative study demonstrating high similarity in safety, purity, and efficacy to the original drugs [2] Group 2: Strategic Partnerships - In 2022, the company entered into a licensing and supply agreement with Organon, granting Organon exclusive commercialization rights for several biosimilars, including BILDYOS and BILPREVDA, outside of China [2] - The approval of these biosimilars enhances Organon's portfolio in the U.S., which has been developed over eight years and covers five major therapeutic areas [2] Group 3: Company Commitment - The approval signifies the company's commitment to scientific excellence and product quality, as stated by the CEO, highlighting the goal of providing affordable treatment options that are equivalent in efficacy and safety to the original drugs [1]