Revenue surged by over 70% year-on-year, signaling imminent commercialization breakthroughs for its three key drivers... In 2025, XUANZHUBIO-B successfully entered a phase of full-scale commercialization, further solidifying its self-sustaining capabilities and projecting a crossing of the breakeven point based on its 2025 annual results. While accelerating internal growth, the company is also actively expanding globally through innovation, recently securing a significant business development transaction with Boston Oncology for two of its core commercial products. From the perspective of sustained performance improvement, with commercialization breakthroughs expected in the next two years, coupled with the continued realization of milestone payments from subsequent BD deals, the company is poised to enter a positive cycle of innovation value release. Furthermore, XUANZHUBIO-B recently completed the filing for full circulation of its H-shares, which is expected to fundamentally improve the stock's liquidity in the secondary market. As the stock price more accurately reflects its intrinsic value, the company's status as a Hong Kong Stock Connect constituent will also be reinforced, laying a solid foundation for the market realization of its accelerating earnings inflection point and valuation recovery.
With full-scale commercialization commencing in 2025, breakthroughs are anticipated within the next two years. XUANZHUBIO-B's 2025 annual results have been officially released. Benefiting from the initial commercialization of two key products in its oncology portfolio, the company achieved revenue of 51.772 million yuan, a significant increase of 72.0% year-on-year. Although XUANZHUBIO-B's two core oncology products were in the early stages of commercialization in 2025, the company had proactively established a preliminary, mature sales system with a professional team exceeding 150 members. Examining the details of commercialization implementation reveals impressive progress in building its national distribution network. Within less than seven months from regulatory approval to year-end, the company achieved coverage for Piroxiclib in 500 hospitals and 206 Direct-to-Patient pharmacies, spanning all 31 provinces, municipalities, and autonomous regions nationwide, and completed its listing on all provincial centralized drug procurement platforms during the period. For Derolac, the company successfully secured coverage in 200 hospitals and 206 DTP pharmacies, focusing on key provinces and cities like Beijing, Shanghai, Guangzhou, and Shenzhen. Regarding the critical aspect of reimbursement, Piroxiclib was included in the National Reimbursement Drug List in the same year it was approved for market, leveraging policy benefits to accelerate clinical penetration and commercial scale-up.
Despite strong revenue growth from innovative drugs in 2025, XUANZHUBIO-B remains in the early stages of commercialization. As core commercial products continue to gain market share, the company is expected to achieve further breakthroughs in product commercialization in 2026 and 2027. Currently, XUANZHUBIO-B demonstrates strong expectations for commercial scaling within the next two years. In March of this year, a significant new indication for Piroxiclib was approved: first-line treatment of HR+/HER2- advanced breast cancer in combination with an aromatase inhibitor. This marks the third indication approved in China for Piroxiclib, following its earlier approvals for second-line combination therapy with Fulvestrant and later-line monotherapy. With this first-line approval, the drug has become the first and only CDK4/6 inhibitor in China to cover the entire treatment course (first-line, second-line, and later-line) for HR+/HER2- advanced breast cancer. It is also the first monotherapy approved domestically with globally leading efficacy data, positioning Piroxiclib to strongly enter the large breast cancer market with differentiated advantages. Data indicates that the Chinese CDK2/4/6 inhibitor market is projected to reach 13 billion yuan by 2032. Furthermore, breast cancer, having the highest incidence rate among malignancies in women globally, is expected to reach approximately 435,000 cases in China by 2032, with about 75% being the HR+/HER2- subtype, representing a substantial unmet medical need. As an outcome of the National "Major New Drug Innovation" program, Piroxiclib holds a significant first-mover advantage as "China's first and only." The first-line approval expands its target patient population from later-line treatment to a broader newly diagnosed group, significantly moving the market access point forward. Moreover, this first-line indication is expected to be included in the updated NRDL through the 2026 year-end医保谈判, potentially leading to breakthrough volume growth facilitated by reimbursement.
As for Derolac, another key product in XUANZHUBIO-B's oncology pipeline targeting ALK-rearranged advanced non-small cell lung cancer, it is anticipated to achieve breakthrough sales volume in 2027, following its expected inclusion in the NRDL via the 2026 year-end negotiation. Analyzing expense trends, the company achieved a gross profit of 33.369 million yuan during the reporting period, an increase of 102.33% year-on-year, while its annual net loss narrowed significantly by 55.88%, signaling an accelerated release of profit potential to the market. As commercialization is expected to accelerate and breakthrough in 2026 and 2027, XUANZHUBIO-B may cross the breakeven point in the near term, significantly exceeding previous market expectations.
Demonstrating BD prowess with excellent products, internal growth combined with overseas revenue enhances growth certainty. In the current environment, a key indicator of high investment certainty for an innovative biopharma company is the shift of its cash cycle pillar from financing cash flow to operating net cash flow. XUANZHUBIO-B's promise lies not only in internal growth driven by key commercial products but also in its active global expansion strategy, enhancing the realization of global commercial value and growth certainty. On April 9 this year, XUANZHUBIO-B entered into a significant overseas licensing collaboration with Boston Oncology, granting exclusive rights and supply agreements for its two core innovative oncology drugs, Piroxiclib and Derolac, across over 20 countries in the Middle East and North Africa. Under the agreement, XUANZHUBIO-B is eligible to receive total potential milestone payments exceeding $100 million, plus royalties on regional sales, which will continuously bolster its cash flow and provide solid support for growth in 2026 and beyond.
A greater driver for the increasing investment certainty surrounding XUANZHUBIO-B stems from the global commercial value realization of its core assets. Emerging markets are increasingly becoming significant contributors to global innovative drug market growth, driven primarily by two factors: the刚性治疗需求 from the local disease burden and the gradual improvement in payment capacity due to economic development and policy optimization. Taking Saudi Arabia as an example, under its "Vision 2030," the government plans to increase healthcare spending as a percentage of GDP from the current approximately 5% to a higher level, actively promoting private healthcare and medical tourism with the goal of establishing Riyadh as a regional medical hub. More importantly, while regulatory systems in these regions differ from the FDA/EMA, the barriers to entry and requirements for bridging studies are relatively flexible. For companies like XUANZHUBIO-B with robust late-stage clinical data, the Middle East presents a practical and efficient monetization channel, underpinned by the company's strong innovative product capabilities as the core support. Following the presentation of Piroxiclib's BRIGHT series clinical study results at major conferences, the other core product involved in this BD deal, Derolac, presented its Phase III head-to-head data against Crizotinib at the 2026 AACR conference. The results demonstrated superior survival benefits for Derolac in the first-line treatment of ALK-positive NSCLC, with its notable intracranial anti-tumor activity achieving an intracranial objective response rate as high as 91.7%, garnering significant market attention and providing strong data support for the global expansion of the company's core assets.
Leveraging the substantial clinical needs in emerging markets and the proven efficacy of its core products, XUANZHUBIO-B's deep collaboration with Boston Oncology utilizes the latter's expertise in pharmaceutical sales and local regional resources in the Middle East. This partnership can effectively reduce XUANZHUBIO-B's overseas market development costs, shorten time-to-market, and enhance product accessibility and competitiveness through the partner's local sales channels, making significant contributions to the global deployment of future key innovative assets and the realization of XUANZHUBIO-B's international value.
In conclusion, despite recent volatility in the Hang Seng Index and the Hong Kong-listed biotech sector leading to what appears to be undervaluation of fundamentally sound companies like XUANZHUBIO-B, the accelerating commercialization of its key product drivers and steady progress across multiple innovative technology fronts are expected to continuously validate the company's value creation. With the completion of the H-share full circulation filing further facilitating two-way capital flow between the mainland and Hong Kong, the recent market sentiment-driven sell-off may have created a highly attractive valuation anchor point for XUANZHUBIO-B.
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