Two cancer products were intensively approved during the year, looking at the innovative value of Xuanzhu Biology (02575) from the perspective of product strength

The global biotechnology sector continues to evolve in the intertwining of capital rationality and passion for innovation, and the Chinese pharmaceutical industry is undergoing a profound revaluation. From relying on “storytelling” to focusing on “product strength verification”, from homogenizing internal volume to pursuing source innovation and global value, the competitive logic of the industry has fundamentally changed.

In this context, Xuanzhu Biotech (02575) ushered in a centralized implementation period for its tumor pipeline in 2025 — its self-developed CDK4/6 inhibitor pyroxil and ALK inhibitor diroac were approved for marketing during the year. Together with the digestive product anneprazole sodium that was marketed earlier, they formed the “troika” driving the company's commercialization.

In terms of market performance, the company's stock price has continued to rise since its listing. This trend reflects the market's recognition of the company's product prospects and confidence in the company's subsequent development. So, what is the actual product strength that supports this market confidence?

From the back line to the front line, the CDK4/6 inhibitor pyrroxil full-scene indication layout was formed

The Zhitong Finance App learned that at the 2025 European Society of Medical Oncology (ESMO) Annual Meeting, which just ended this year, Xuanzhu Biotech disclosed research data on its self-developed CDK4/6 inhibitor phase III (BRIGHT-3) in the form of a poster.

Intuitively judging from the data, this randomized double-blind trial covering 58 centers and 397 patients in China has clearly demonstrated the clinical application potential of pyroxil 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, when the median follow-up was 20.7 months, the median progression-free survival (MPFs) assessed by the researchers and independent review committee had not been achieved, which was significantly superior to the control group at 18.43 months and 19.55 months; the objective response rate (ORR) reached 63.5%, an increase of 21 percentage points over the control group; the risk of disease progression or death was reduced by 47%, with a risk reduction of up to 64% for patients with liver metastases.

In terms of safety, most common adverse events such as diarrhea and neutropenia in combination with piroxil are grade 1-2, and effective management can be achieved by supporting treatment or dose adjustment. Controllable safety further strengthens the foundation for clinical application.

Based on the above data, the State Drug Administration accepted the marketing application for a new drug for first-line treatment of this drug in May of this year, marking the official impact of this domestically produced innovative drug on the first-line breast cancer treatment market.

It is worth noting that the first-line data revealed by piroxil this time is not an isolated clinical breakthrough, but a key implementation of its “full-cycle treatment strategy.”

Back in May of this year, the drug was approved by the State Drug Administration for two indications. The first is the second-line treatment of patients with advanced endocrine therapy in combination with fluvirizil, and the second is that the single drug is used for back-line patients who have gone through two or more types of endocrine treatment+one type of chemotherapy, making it the first and only CDK4/6 inhibitor approved for single drug indications in China.

The first-line NDA has now entered the review stage, which means that piroxilil is about to complete the full chain coverage from late-line rescue treatment and second-line combination treatment to first-line initial treatment, while achieving a “single drug+combination” dual-model layout.

This three-dimensional strategy accurately matches clinical needs. For newly diagnosed advanced patients, first-line combination can achieve long-term disease control. However, for intractable patients who have failed to be treated, a single drug plan can provide an effective remedy. From a commercial perspective, the comprehensiveness of pirosilil indications will significantly expand the patient coverage base and lay a key foundation for subsequent market penetration.

Intracranial ORR was over 91%, and Diroac brought a new strategy to break the game for ALK-positive NSCLC brain metastasis

If “single drug + combination” and “backline to frontline” are used to build a competitive barrier on the HR+/HER2 - advanced breast cancer circuit, then Diroac focuses on ALK positive NSCLC brain metastasis, a segment where clinical needs are just needed, which is expected to bring a new strategy to break the clinical demand with an intracranial objective remission rate (IC-ORR) of over 91%.

Targeted treatment for ALK-positive NSCLC has gone through three generations of iterations. From first-generation crizotinib pioneering targeted therapy to second-generation drugs further extending patients' progression-free survival (PFS), the overall survival (OS) and quality of life of patients have improved markedly, but brain metastasis is still a key pain point that has not been fully met. ALK-positive NSCLC patients have a high incidence of brain metastases and a high risk of progression. Most inhibitors have limited intracranial penetration due to the presence of a blood-brain barrier. Although some second-generation drugs have improved, some patients still have poor intracranial lesion control, which directly limits survival benefits. This clinical gap also provides a broad market space for targeted innovative drugs.

Judging from product competitiveness, the core advantages of Diroac focus on the two dimensions of “mechanism accuracy” and “clinical data superiority”.

On the one hand, its molecular structure has been optimized in a targeted manner, and can efficiently penetrate the blood-brain barrier and directly hit the core bottleneck of brain metastasis treatment in terms of mechanism of action, providing a key foundation for continuous control of intracranial lesions — this is also a core differentiating point that distinguishes this drug from traditional ALK inhibitors; on the other hand, head-to-head clinical study (NCT05204628) data fully validates its efficacy advantages: in patients with advanced ALK positive NSCLC, the objective remission rate (ORR) reached 88.5%, and the median progression-free survival (mPFs) was long 31.3 months, which is more than double the 12.9 month extension of crizotinib, which means that patients can obtain more long-lasting disease control; what is more critical is the breakthrough performance in people with brain metastases: the intracranial objective remission rate (IC-ORR) was as high as 91.7%, far exceeding 11.1% of crizotinib, and the median intracranial duration of remission (IC-DOR) has not been achieved. Compared with 3.55 months of cozotinib, this type of strong and long-lasting intracranial lesion inhibition was fully demonstrated. Patients were offered a new treatment option.

Judging from clinical value and market logic, brain metastasis, as a high-incidence and difficult complication of ALK-positive NSCLC, corresponds to a clear unmet need. With its “high intracranial penetrability,” Diroac is expected to establish a strong competitive barrier in this sub-race track. As the commercialization of the product progresses, its core value of accurately solving clinical pain points will continue to be transformed into market penetration and form a synergistic effect with piroxilil.

Conclusions

In the context of the return of value in the pharmaceutical industry to product strength, Xuanzhu Biotech approved two new oncology drugs in 2025, completing the key implementation of innovative value. Pirocilil lays out the breast cancer racetrack with “differentiated indications”. Diroac fills the gap in brain metastasis treatment with high intracranial penetrability and over 91% IC-ORR. Both form a “troika” commercialization pattern with aneprazole sodium, laying the core foundation for the company's long-term growth.