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]

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 partnership 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]

Group 1 - A lawsuit has been filed against Organon & Co. by an investor over alleged violations of securities laws, claiming that the company provided misleading statements while concealing material adverse facts [2] - The lawsuit specifically addresses the company's capital allocation priorities, particularly regarding a significant reduction in quarterly dividends by 70% following the acquisition of Dermavant [2] - Investors who purchased shares of Organon & Co. prior to October 2024 are encouraged to contact the Shareholders Foundation for potential options [1][3] Group 2 - The Shareholders Foundation, Inc. is involved in monitoring legal issues related to shareholders and provides information on securities class actions and settlements [3] - The foundation is not a law firm and does not initiate legal actions, but serves as a public service to inform investors [3]

Group 1 - Organon & Co.'s securities are currently undervalued, with a forward P/E ratio of approximately 2.4x compared to the sector average of 17x [1] - Following the separation from Merck, Organon's stock price has fallen below $10 [1] Group 2 - The article emphasizes that a low price does not necessarily indicate a good investment opportunity [1]