Sotoclar becomes the first new BCL-2 inhibitor approved in the United States in ten years, and is currently the only approved BCL-2 targeted drug for the indication of relapsed/refractory mantle cell lymphoma (MCL)
<h4>Key Points:</h4>
<ul>
<li>The approval of Sotoclar can retain the large user base of Zebutini within BeiGene's treatment system, greatly enhancing the medication adherence of patients and doctors.</li>
<li>The company has raised its revenue forecast to between 43.6 billion and 45.2 billion yuan, with the gross profit margin remaining high at around 80%.</li>
</ul>
Molly
For innovative pharmaceutical companies with limited product accumulation, the explosive growth of a single blockbuster product is often a key driver for achieving profitability. However, if a single product dominates the revenue structure for a long time, it may raise concerns in the capital market about the long-term stability of its revenue structure. On May 14, BeiGene, Ltd. (688235.SH; 06160.HK; ONC.US) announced that its self-developed next-generation highly selective BCL-2 inhibitor Sotoclar received accelerated approval from the U.S. Food and Drug Administration (FDA), which is expected to build a more comprehensive product matrix for hematologic tumors.
According to BeiGene's announcement, Sotoclar is approved in the U.S. for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL) who have previously received at least two lines of systemic therapy (including BTK inhibitors). This is the first new BCL-2 inhibitor approved in the U.S. market in ten years. Additionally, Sotoclar was approved in January of this year for MCL and chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) in China, allowing BeiGene to efficiently complete its BCL-2 layout in the two major core markets of China and the U.S. within six months.
More critically, in the field of hematologic tumor treatment, BCL-2 complements BeiGene's flagship product, the BTK inhibitor Zebutini, in terms of mechanism of action. Patients who have been on BTK inhibitors for a long time inevitably develop resistance, and the BCL-2 pathway is downstream of the BTK resistance mechanism. The approval of Sotoclar can retain the large user base of Zebutini within BeiGene's treatment system, greatly enhancing the medication adherence of patients and doctors.
However, the capital market's reaction to this significant pipeline progress has been relatively muted. From May 14 to 18, BeiGene's Hong Kong stock price fell consecutively, with a cumulative decline of 6.8%. This trend was more affected by the overall market and sector pullback during the same period, with the Hang Seng Index also declining, and the Hang Seng Innovative Drug Index focusing on the industry showing a cumulative decline of 6.5%, indicating a weak overall sentiment in the sector. Additionally, due to the positive clinical data of Sotoclar and the FDA approval having been anticipated by the market, this good news had already been partially factored into the stock price months ago. Therefore, after the official announcement, the market instead exhibited a &#34;good news realization&#34; effect, with some funds choosing to sell
<h4>First Quarter Performance Continues to Be Profitable</h4>
Setting aside short-term stock price fluctuations, BeOne Medicines' financial fundamentals are at their historical best stage. The Q1 2026 report disclosed on May 6 shows that the company achieved operating revenue of 10.544 billion yuan, a year-on-year increase of 31%; it realized a net profit attributable to shareholders of 1.608 billion yuan, turning losses into profits compared to the previous year, continuing the positive trend of the company achieving annual profitability for the first time in 2025.
The financial report shows that product revenue accounted for as much as 98% of total revenue, reaching 10.321 billion yuan, a year-on-year increase of 29.3%. Among them, the global sales of Zebutini reached 7.598 billion yuan, a year-on-year increase of 33.5%. From a regional market perspective, the United States remains the core growth engine for Zebutini, with sales in the first quarter reaching 5.283 billion yuan, a year-on-year increase of 30.8%, accounting for nearly 70% of the product's global revenue. The European market saw even more rapid growth, with sales increasing by 51.4% year-on-year to 1.266 billion yuan. In addition, the company's other product lines also showed a robust trend, with global sales of the PD-1 monoclonal antibody Tislelizumab in the first quarter reaching 1.429 billion yuan, a year-on-year increase of 14.8%; sales from authorized products from Amgen (AMGN.US) amounted to 989 million yuan.
Based on the strong performance in the first quarter, BeOne Medicines has raised its performance forecast for 2026: it expects full-year operating revenue to be between 43.6 billion yuan and 45.2 billion yuan, with gross margin remaining high at around 80%; the adjusted operating profit for the year is expected to be raised to between 10 billion yuan and 10.6 billion yuan.
In addition to its self-developed pipeline, BeOne Medicines is also continuously expanding its frontier layout through external collaborations (BD). In the first quarter of this year, the company reached an exclusive option agreement with Huahui Anjian, obtaining global rights to the novel trispecific antibody HH160 (BON-110) targeting PD-1, VEGF-A, and CTLA-4. This means that, against the backdrop of increasingly abundant cash flow, the company is actively leveraging BD to quickly enter the next generation of immunotherapy frontier target combinations.
BeOne Medicines currently has a price-to-earnings ratio of about 66 times, significantly higher than the price-to-earnings ratio of 46 times for domestic traditional pharmaceutical leader HengRui Medicine (600276.SH; 1276.HK). This valuation premium reflects the market's higher pricing for its globalization platform capabilities and the growth potential contained in the hematology product matrix centered around Zebutini and Sotokura. Whether future valuations can be continuously supported will mainly depend on whether Zebutini's sales peak can further break through and whether the commercialization process of Sotokura after approval can quickly ramp up

688235

159992

512010

BeOne Medicines' BCL-2 inhibitor Sotorasib has received accelerated approval from the FDA, becoming the first new BCL-2 targeted drug approved in the United States in the past decade, suitable for relapsed/refractory mantle cell lymphoma. The company expects net profit in the first quarter to exceed 1.6 billion yuan, with revenue expectations raised to between 43.6 billion and 45.2 billion yuan, maintaining a gross margin of 80%. This move is expected to break the reliance on a single product and enhance medication adherence among patients and doctors

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BeOne Medicines is expected to break the "single product dependence" with a net profit exceeding 1.6 billion yuan in the first quarter