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BeOne Medicines Ltd. (ONC) SEC Filings, Apr-May 2026

ONC NASDAQ

Ticker history: BGNE became ONC (BeOne Medicines Ltd.) on . Earlier news and filings retain their original names and dates. View BGNE history.

The BeOne Medicines Ltd. (ONC) SEC filings page on Stock Titan provides access to the company’s U.S. regulatory disclosures, including current reports on Form 8‑K and other documents filed with the Securities and Exchange Commission. BeOne is a Switzerland‑domiciled global oncology company whose American Depositary Shares are registered with the SEC, while its ordinary shares trade on the Hong Kong Stock Exchange and it also reports to the STAR Market in Shanghai.

Through its filings, BeOne reports on financial results, material agreements and corporate events. BeOne Medicines Ltd.'s recent Forms 8-K announced quarterly financial results, describing revenue growth driven primarily by BRUKINSA product sales and contributions from TEVIMBRA and in-licensed products. Other 8‑K filings detail a royalty purchase agreement with Royalty Pharma tied to royalty rights on IMDELLTRA (tarlatamab) ex‑China net revenue, as well as the creation of related financial obligations and escrow arrangements.

Additional 8‑K reports cover topics such as the termination of a prior credit facility after arranging new financing, and the appointment and compensation terms of senior research and development leadership. The company also furnishes information about its interim reports filed with the STAR Market, including financial data prepared under China Accounting Standards and summaries of differences from U.S. GAAP.

On Stock Titan, users can review these ONC filings alongside AI‑generated summaries that explain the main points of each document in plain language. This includes highlighting key items in earnings‑related filings, summarizing the structure and implications of material agreements, and pointing out governance or leadership changes disclosed under Item 5.02 of Form 8‑K. Investors can also use the filings page to monitor how BeOne describes its oncology portfolio, collaborations and financial position over time, and to cross‑reference U.S. disclosures with the company’s press releases and non‑U.S. reporting.

Real‑time updates from EDGAR, combined with AI‑assisted overviews, help readers navigate lengthy filings and focus on sections most relevant to their interests, whether they are following BeOne’s hematology and solid tumor programs, its financing arrangements or its multi‑exchange reporting obligations.

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BeOne Medicines Ltd. reports that the U.S. FDA has granted accelerated approval for BEQALZI (sonrotoclax), a next-generation BCL2 inhibitor, to treat adults with relapsed or refractory mantle cell lymphoma after at least two prior systemic therapies, including a BTK inhibitor.

The decision is based on a Phase 1/2 study showing a 52% overall response rate, a 16% complete response rate, and a median duration of response of 15.8 months. Approval is conditional on confirmatory trial results, and the label carries important safety warnings, including tumor lysis syndrome and serious infections.

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BeOne Medicines Ltd. ownership update: Capital International Investors filed an amendment to report beneficial ownership of 65,211,266 shares, representing 4.2% of the class based on 1,540,975,898 shares outstanding. The filing states CII has sole voting power over 64,349,154 shares and sole dispositive power over 65,211,266 shares. The report also notes 4,638,440 Depository Receipts that the filer says represent 60,299,720 Common Stock.

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ONC submitted a Form 144 reporting the proposed sale of 1,328 ADS on 05/13/2026 following an exercise of stock options. The filing also discloses prior Rule 10b5-1 sales of 332 ADS on 04/08/2026 for $103,447.88 and 341 ADS on 03/11/2026 for $102,300.00.

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BeOne Medicines Ltd. filed a post-effective Form S-3 shelf registration to replace an expiring registration, registering up to 398,880,905 Ordinary Shares, including 374,373,961 Ordinary Shares represented by 28,797,997 ADSs (each ADS = 13 Ordinary Shares). The prospectus states BeOne is not selling any shares here and will not receive proceeds; proceeds, if any, will go to the listed selling shareholders. The registration covers resale by Amgen, entities affiliated with Baker Bros. Advisors and HHLR Advisors under existing registration rights. The filing notes cross‑listings on HKEx, Nasdaq and the STAR Market and highlights business, liquidity and China‑related operational risk disclosures incorporated by reference.

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BeOne Medicines Ltd. files a new shelf registration on Form S-3 to replace an expiring registration and permit, from time to time, primary offerings and resales of ordinary shares, ADSs, preferred shares, debt securities, warrants and units.

The shelf contemplates offerings by the company and selling shareholders, with proceeds to the company disclosed only in future prospectus supplements; the company discloses key context figures including $731 million in cash and cash equivalents as of March 31, 2026, approximately 1,540,975,898 Registered Shares issued, and recent product and pipeline highlights (BRUKINSA sales of $3.9 billion in 2025). The registration replaces an earlier S-3 that would expire on May 9, 2026.

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BeOne Medicines Ltd. reported Q1 2026 revenue of $1.51B, up 35.5% from a year earlier, driven mainly by strong growth in BRUKINSA and TEVIMBRA. Net income rose sharply to $227.4M, compared with near breakeven a year ago, as higher sales and improved gross margin outpaced increased R&D and commercial spending.

Product revenue reached $1.49B, led by BRUKINSA at $1.09B (up 38.3%) and steady growth in Amgen-partnered products. Gross margin improved to 88.8% on a richer mix of BRUKINSA and efficiency gains. Operating cash flow climbed to $201.3M, lifting cash, cash equivalents and restricted cash to $4.85B, while total debt stood at $1.08B and the IMDELLTRA royalty financing liability at $904.4M.

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BeOne Medicines reported a very strong first quarter of 2026, with total revenue of $1.51 billion, up 35% from the prior year. Net product revenue was $1.49 billion, driven mainly by oncology medicines.

Flagship BTK inhibitor BRUKINSA generated global sales of $1.1 billion, up 38%, including U.S. sales of $761 million (up 35%). TEVIMBRA reached $206 million in global sales, while Amgen in-licensed products contributed $142 million.

GAAP income from operations rose to $249.9 million and GAAP net income to $227.4 million, compared with nearly break-even a year earlier. GAAP diluted earnings were $1.96 per ADS, and non‑GAAP diluted earnings were $3.24 per ADS. Free cash flow improved to $160.5 million from negative levels.

The company raised full‑year 2026 guidance, now expecting total revenue of $6.3 billion–$6.5 billion and GAAP operating income of $750 million–$850 million. Management highlighted a broad oncology pipeline with multiple late‑stage milestones and regulatory decisions anticipated through 2026–2027.

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BeOne Medicines Ltd. has released its 2026 proxy statement for the June 11, 2026 annual general meeting in Zurich, outlining 20 governance, compensation and capital-authorization proposals. Management highlights 2025 as a transformational year, with the company achieving GAAP profitability for the first time and generating meaningful cash flow.

The letter to shareholders emphasizes BeOne’s growing oncology franchise, led by BTK inhibitor BRUKINSA, which delivered $3.9 billion in 2025 global revenue, up 49% year over year. The company reports more than two million patients treated with its medicines and a workforce of nearly 12,000 employees across six continents.

Shareholders are asked to approve Swiss statutory financial statements, carry forward a Swiss standalone accumulated loss of $7.64 million, discharge directors and executives from liability under Swiss law, elect or re-elect ten directors, and ratify Ernst & Young entities as auditors. Additional resolutions seek say-on-pay approvals, updated equity plans, a mandate to issue up to 20% of issued shares, a 10% share repurchase mandate, and an authorization to allocate shares to Amgen to maintain its ownership percentage in future offerings.

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Schedule 13D/A
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Baker Bros. Advisors and affiliates report an 8.0% beneficial ownership stake in BeOne Medicines Ltd. (formerly BeiGene Ltd.) through ordinary shares and American Depositary Shares. The main adviser entities each report 115,462,653 Ordinary Shares, while Julian and Felix Baker each report 115,918,313 Ordinary Shares.

The filing notes BeOne’s redomiciliation to Switzerland and name change, and confirms that each ADS represents thirteen Ordinary Shares. It also discloses that Felix J. Baker has been nominated to serve as a director and Lead Director, while two existing Baker-affiliated directors are not standing for re-election. The Baker-managed funds state they hold their position for investment purposes but may increase or decrease holdings over time.

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FAQ

How many BeOne Medicines Ltd. (ONC) SEC filings are available on StockTitan?

StockTitan tracks 175 SEC filings for BeOne Medicines Ltd. (ONC), including 10-K annual reports, 10-Q quarterly reports, 8-K current reports, and Form 4 insider trading disclosures. Each filing includes AI-generated summaries, impact scoring, and sentiment analysis.

When was the most recent SEC filing for BeOne Medicines Ltd. (ONC)?

The most recent SEC filing for BeOne Medicines Ltd. (ONC) was filed on May 15, 2026.