According to the official website of the National Medical Products Administration (NMPA), the generic apalutamide tablets submitted by Kerui Pharmaceutical, a subsidiary of Qingfeng Pharmaceutical Group, were approved for production on May 19 and are considered to have passed the consistency evaluation. This is the third endocrine therapy chemical drug approved for Qingfeng Pharmaceutical, marking a new milestone in the company's R&D and commercialization strategy in the field of prostate cancer treatment.
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Apalutamide tablets: A new generation of androgen receptor inhibitors
Blockbuster drugs for prostate cancer treatment
Apalutamide is a new generation of oral, highly selective nonsteroidal androgen receptor (AR) inhibitors. It competitively blocks androgen binding by binding to the intracellular ligand-binding domain of AR with high affinity, inhibiting receptor conformational changes and nuclear translocation, and preventing AR translocation into the nucleus.¹ Simultaneously, it blocks the binding of AR to DNA response elements, inhibiting the transcription of pro-proliferation and pro-survival genes, thereby synergistically inhibiting tumor cell proliferation and inducing apoptosis through multiple mechanisms .² This drug has no risk of antagonistic conversion in routine clinical practice. ³ Furthermore, it maintains a certain inhibitory effect even in cases of AR overexpression or mutation . ⁴
Apalutamide tablets are indicated for two key indications :

Combined androgen deprivation therapy (ADT) for adult patients with non-metastatic castration-resistant prostate cancer (NM-CRPC) at high risk of metastasis;

Combined androgen deprivation therapy (ADT) for adult patients with metastatic endocrine therapy-sensitive prostate cancer (mHSPC).

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Deepening its expertise in endocrine therapy and perfecting its prostate cancer product portfolio.
Since its launch, apalutamide's global sales have increased from US$1.881 billion in 2022 to nearly US$3 billion in 2024, with an average annual growth rate of over 45%. According to Menet, apalutamide's sales have also increased significantly since it was included in China's medical insurance catalog, jumping from tens of millions to hundreds of millions within three years. In 2025, its terminal sales exceeded 800 million yuan, a year-on-year increase of nearly 15%, with market demand continuing to rise and a strong growth momentum.

The approval of apalutamide tablets marks another significant step forward for Qingfeng Pharmaceuticals in the fields of endocrine therapy and anti-tumor treatment. Previously, the company had already received approval for several endocrine therapy drugs, including abiraterone acetate tablets and enzalutamide soft capsules. Apalutamide tablets, as the company's third approved endocrine therapy drug, will create a synergistic effect with existing products, providing more comprehensive treatment options for prostate cancer patients at different stages.

Qingfeng Pharmaceutical Group has long focused on the field of anti-tumor treatment and has developed a rich product pipeline covering multiple sub-sectors such as targeted therapy, endocrine therapy, and adjuvant chemotherapy. In the future, the company will continue to be driven by clinical needs, further developing differentiated and high-value products to provide patients with more safe, effective, and accessible treatment options.

https://mp.weixin.qq.com/s/7GgUtsZPtsp5SyP0xVMEWg