ONC 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-05-06

• BeOne Medicines is a global oncology company that is discovering and developing innovative treatments for cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities …

• •Received Orphan Drug Designation in Japan for the treatment of adult patients with relapsed or refractory (“R/R”) marginal zone lymphoma (“MZL”).

• •Submitted New Drug Application in Japan for R/R MZL and tablet formulation.

• •Launched and commercially available in China for the treatment of adult patients with R/R mantle cell lymphoma (“MCL”) and R/R chronic lymphocytic leukemia (“CLL”)/small lymphocytic lymphoma (“SLL”).

• •Included in the European Society of Medical Oncology (“ESMO”) guidelines as a recommended third-line treatment for R/R MCL patients.

相对上期删除的文字 · 来源:10-Q · 2025-11-06

• Our third quarter financial results show topline growth and a strong liquidity position to support ongoing operations and strategic priorities. BRUKINSA is now the global revenue leader in the BTK inhibitor class. Our late-stage hematology portfolio continues to advance with sonrotoclax and the BTK …

• •Nearly 50 abstracts accepted at American Society of Hematology (ASH) Annual Meeting, highlighting late-stage hematology portfolio

• On October 13, 2025, we announced that the U.S. Food and Drug Administration (“FDA”) has granted Breakthrough Therapy Designation for sonrotoclax, a next-generation and potentially best-in-class investigational BCL2 inhibitor, for the treatment of adult patients with relapsed or refractory (R/R) man…

• On August 29, 2025, we announced positive topline results from a Phase 1/2 study (BGB-11417-201) of sonrotoclax, a next-generation and potentially best-in-class investigational BCL2 inhibitor, in adult patients with relapsed/refractory mantle cell lymphoma, following treatment with a Bruton’s tyrosi…

• On August 27, 2025, we announced that the European Commission (“EC”) has approved TEVIMBRA (tislelizumab), in combination with platinum-containing chemotherapy as neoadjuvant treatment followed by TEVIMBRA monotherapy as adjuvant treatment, for adult patients with resectable non-small cell lung canc…

相对上期新增的文字 · 来源:10-Q · 2026-05-06

• On September 6, 2024, AbbVie Inc. filed a complaint in the U.S. District Court for the Northern District of Illinois against the Company, one of its wholly-owned subsidiaries and an individual scientist, alleging misappropriation of trade secrets concerning the Company’s BTK degrader program, includ…

• On February 25, 2026, our subsidiaries, BeOne Medicines USA Inc. and BeOne Medicines I GmbH, filed a patent infringement suit under the Hatch-Waxman Act against Zydus Pharmaceuticals (USA) Inc. and Zydus Lifesciences Limited (collectively, “Zydus”) in the United States District Court for the Distric…

• BeOne’s complaint alleges that by filing the ANDA, Zydus infringes certain of BRUKISNA’s Orange Book patents and seeks a permanent injunction to prevent Zydus from commercializing a generic version of BRUKINSA® tablets until the expiration of the asserted patents.

• ANDA litigation is common in the U.S. pharmaceutical industry. We may receive additional notices from other generic drug companies and may file additional ANDA lawsuits in the future.

相对上期删除的文字 · 来源:10-Q · 2025-11-06

• On June 13, 2023, Pharmacyclics LLC (“Pharmacyclics”) filed a complaint in the U.S. District Court for the District of Delaware (the “Court”) against the Company and its subsidiary, BeiGene USA, Inc., which subsequently changed its name to BeOne Medicines USA, Inc., alleging that BRUKINSA infringes …

• On October 12, 2023, the Court entered a joint stipulation filed by the parties to stay the infringement suit pending resolution of a petition for post-grant review (“PGR”) of the ‘803 Patent with the U.S. Patent and Trademark Office (the “USPTO”) that was later filed by the Company on November 1, 2…

• On September 6, 2024, AbbVie Inc. filed a complaint in the U.S. District Court for the Northern District of Illinois against the Company, one of its wholly-owned subsidiaries and an individual scientist, alleging misappropriation of trade secrets concerning the Company’s Bruton’s tyrosine kinase (“B…

相对上期新增的文字 · 来源:10-Q · 2026-05-06

• •Restrictive covenants in our facilities agreements may limit our ability to respond to changes in market conditions or pursue business opportunities.

• •As a Swiss corporation, our flexibility will be limited with respect to certain aspects of capital management.

• •international military conflicts, such as the ongoing conflicts between Russia and Ukraine or in Iran, and related sanctions.

• For example, in 2025, the U.S. imposed tariffs on imports on its trading partners, including Canada, Mexico, the EU and China, and has subsequently proposed additional or alternative tariffs. While certain tariffs have been subsequently invalidated, suspended, modified or temporarily reduced, and th…

• Furthermore, in April 2025, the Bureau of Industry and Security of the U.S. Department of Commerce (“BIS”) initiated an investigation under Section 232 of the Trade Expansion Act of 1962 (“Section 232”) into whether imports of pharmaceutical products present a risk to the national security of the U.…

相对上期删除的文字 · 来源:10-Q · 2025-11-06

• •Your rights as a shareholder changed as a result of the Continuation.

• •As a result of increased shareholder voting requirements following the Continuation, we have less flexibility with respect to certain aspects of capital management than previously.

• For example, in 2025, the U.S. imposed tariffs on imports on its trading partners, including Canada, Mexico, the EU and China. While certain tariffs have been subsequently suspended, modified or temporarily reduced, their impact has already been seen, and we expect will continue to be seen, in globa…

• Furthermore, on April 1, 2025, the Bureau of Industry and Security of the U.S. Department of Commerce (“BIS”) initiated an investigation into whether imports of pharmaceutical products present a risk to the national security of the U.S. This investigation could result in BIS recommending additional …

• *The approval processes of regulatory authorities in the U.S., China, Europe and other comparable regulatory authorities are lengthy, time consuming, costly, and inherently unpredictable. If we experience delays or are ultimately unable to obtain regulatory approval for our drug candidates, our busi…

相对上期新增的文字 · 来源:10-Q · 2026-05-06

• The following table describes for the quarterly period covered by this report each trading arrangement for the purchase or sale of the Company’s securities adopted, modified or terminated by our directors and officers that is either (1) a contract, instruction or written plan intended to satisfy the…

• Name (Title)Action Taken (Date of Action)Type of Trading ArrangementNature of Trading ArrangementDuration of Trading ArrangementAggregate Number of Securities

• (Co-Founder, Chief Executive Officer, and Chairman of the Board of Directors)

• (ii)up to such net number of ADSs to be received upon vesting of unvested RSUs in 2026 after sell-to-cover for withholding tax, to be sold by Mr. Oyler; and

• (iii)up to 60,010 ADSs to be sold by the Pan-Oyler Foundation.

相对上期删除的文字 · 来源:10-Q · 2025-11-06

• During the quarter ended September 30, 2025, none of our directors or officers (as defined in Rule 16a-1(f) under the Exchange Act) adopted, modified or terminated a “Rule 10b5-1 trading arrangement” or a “non-Rule 10b5-1 trading arrangement” (as each term is defined in Item 408 of Regulation S-K).