Two tumor products approved intensively within the year, looking at Xuanzhu Bio (02575) from the perspective of product strength and innovation value.

In the context of the continuous evolution of the global biotechnology field with the intertwining of capital rationality and innovation passion, China Meheco Group is undergoing a profound revaluation of its industry. From reliance on "storytelling" to focusing on "product efficacy validation," from homogenization to the pursuit of original innovation and global value, the industry's competitive logic has undergone a fundamental transformation. In this background, Xuanzhu Biotechnology (02575) is entering a period of concentrated realization of its tumor pipeline in 2025 - its self-developed CDK4/6 inhibitor Palbociclib and ALK inhibitor Lorlatinib have successively received market approval within the year, together with earlier marketed digestive product Anelazol sodium, jointly forming the "three pillars" driving the company's commercialization. In terms of market performance, the company's stock price has been continuously rising since its listing, reflecting the market's recognition of the company's product prospects and confidence in its future development. So, what is the actual product strength that supports this market confidence? From the backline to the frontline, the full-spectrum indication layout of the CDK4/6 inhibitor Palbociclib has taken shape. At the European Society for Medical Oncology (ESMO) Annual Meeting that just ended in 2025, Xuanzhu Biotechnology disclosed the Phase III (BRIGHT-3) study data of its self-developed CDK4/6 inhibitor Palbociclib through posters. From a data perspective, this randomized double-blind trial involving 58 centers in China and 397 patients has clearly demonstrated the clinical application potential of Palbociclib in combination with letrozole or anastrozole in the first-line treatment of HR+/HER2- advanced breast cancer. In terms of efficacy, as of January 10, 2025, with a median follow-up of 20.7 months, the median progression-free survival (mPFS) evaluated by researchers and an independent review committee did not reach, significantly better than the control group's 18.43 months and 19.55 months; the objective response rate (ORR) reached 63.5%, a 21 percentage point increase over the control group; the risk of disease progression or death decreased by 47%, with liver metastasis patients experiencing a higher risk reduction of 64%, multiple key indicators reflecting clear treatment advantages. In terms of safety, the common adverse events of the Palbociclib combination regimen, such as diarrhea and neutropenia, were mostly grade 1-2, and could be effectively managed through supportive treatment or dose adjustment, further consolidating its clinical application foundation. Based on the data support mentioned above, the National Medical Products Administration accepted the new drug market application for the first-line treatment of Palbociclib earlier this year, marking the official launch of this domestically produced innovative drug into the first-line treatment market for breast cancer. It is worth noting that the first-line data disclosed by Palbociclib this time is not an isolated clinical breakthrough, but a crucial move in its "full-course treatment strategy." Looking back to May of this year, the drug had already been approved by the National Medical Products Administration for two indications. One is for the second-line treatment of progressive patients in combination with fulvestrant, and the other is for single-agent use in patients who have failed two or more hormonal therapies plus chemotherapy, becoming the first and only CDK4/6 inhibitor to be approved for a single-agent indication in China. Now that the first-line NDA is in the review stage, it means that Palbociclib is about to complete a full coverage from salvage therapy in the backline, combination therapy in the second line to initial treatment in the first line, and at the same time achieve a dual-mode layout of "single-agent + combination therapy." This three-dimensional strategy precisely matches clinical needs. For newly diagnosed advanced patients, first-line combination therapy can achieve long-term disease control. For difficult-to-treat patients who have failed treatment, a single-agent regimen can provide an effective salvage option. From a commercial perspective, the comprehensive indications of Palbociclib will significantly expand the patient coverage base, laying a crucial foundation for future market penetration. With an ORR of over 91% in intracranial lesions, Lorlatinib brings a breakthrough strategy for the treatment of ALK-positive NSCLC brain metastases. If Palbociclib has built competitive barriers in the HR+/HER2- advanced breast cancer track with "single-agent + combination therapy" and "from backline to frontline", then Lorlatinib focuses on the clinical need for brain metastases in ALK-positive NSCLC, and is expected to bring a new strategy with an intracranial objective response rate (IC-ORR) of over 91%. The targeted therapy of ALK-positive NSCLC has undergone three generations of iterations, from the first-generation crizotinib opening the era of targeted therapy, to the second-generation drugs further extending patients' progression-free survival (PFS), overall survival (OS), and significantly improving quality of life, but brain metastasis remains a key unmet need. ALK-positive NSCLC patients have a high incidence of brain metastases and a high risk of progression, and the presence of the blood-brain barrier limits the intracranial penetration of most inhibitors. Although some second-generation drugs have improved, some patients still have inadequate control of intracranial lesions, directly restricting survival benefits. This clinical gap also provides a broad market space for targeted innovative drugs. From the perspective of product competitiveness, Lorlatinib's core advantages focus on "mechanical precision" and "superior clinical data." On the one hand, its molecular structure has been optimized for targeted penetration of the blood-brain barrier, directly addressing the core bottleneck of brain metastasis treatment from a mechanistic perspective, providing a crucial foundation for the sustained control of intracranial lesions - this is also the core differentiation highlight of the drug from traditional ALK inhibitors; on the other hand, head-to-head clinical study (NCT05204628) data fully validate its efficacy advantages: in ALK-positive advanced NSCLC patients, the objective response rate (ORR) reaches 88.5%, the median progression-free survival (mPFS) is as long as 31.3 months, more than doubling the 12.9 months of crizotinib, which means patients can achieve more prolonged disease control; most importantly, in the group of patients with brain metastases, the breakthrough performance of Lorlatinib is impressive: the intracranial objective response rate (IC-ORR) of Lorlatinib reaches 91.7%, far exceeding crizotinib's 11.1%, and the median intracranial response duration (IC-DoR) has not yet been reached, as compared to crizotinib's 3.55 months, fully demonstrating strong and sustained inhibitory ability on intracranial lesions, providing a new treatment option for these refractory patients. Looking at it from the perspective of clinical value and market logic, brain metastasis, as a common and challenging complication of ALK-positive NSCLC, represents a clear unmet need. Lorlatinib, with its "high intracranial penetration," is expected to establish a strong competitive barrier in this specific track. With the advancement of commercialization, its core value of precisely solving clinical pain points will continue to be transformed into market penetration power, forming a synergistic effect with Palbociclib. Conclusion In the context of the pharmaceutical industry's return to the value of product efficacy, Xuanzhu Biotechnology's two new oncology drugs approved in 2025 have completed the key realization of innovative value. Palbociclib's "differentiated indications" layout in the breast cancer track, and Lorlatinib's filling of the treatment gap in brain metastases with high intracranial penetration and over 91% IC-ORR, along with Anelazol sodium constitute the commercialization pattern of the "three pillars," laying a core foundation for the company's long-term growth.