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Shandong Xinbo Assists Ningbo Aixoso in Obtaining Clinical Approval for Innovative Endometriosis Drug

2025/10/23

According to the official website of the Center for Drug Evaluation (CDE) under the National Medical Products Administration and publicly available data, Shandong Xinbo Pharmaceutical Research Co., Ltd. (hereinafter referred to as "Shandong Xinbo") has assisted Ningbo Aikexue Pharmaceutical Technology Co., Ltd. in obtaining an implied approval for clinical trials of the new drug "EGFNASA Capsule" (Acceptance No.: CXHL2500729).

As a key partner in the R&D process, Shandong Xinbo strictly adheres to the guidelines of the NMPA and ICH. Leveraging its profound expertise in preclinical safety evaluation, the company provided critical technical support for the development of this innovative drug, facilitating the partner's successful acquisition of clinical trial approval.


Focusing on clinical pain points: an innovative drug that fills the treatment gap
Endometriosis, as a common gynecological disease affecting the health of women of childbearing age worldwide, causes chronic pain, infertility, and other complications that have long plagued patients, seriously affecting their quality of life, especially their marital relationship. The first drug successfully used for clinical treatment was the androgen regulator danazol, which has been almost completely replaced by progestogens and GnRH inhibitors (agonists) due to its masculine secondary sexual side effects. Although these two types of drugs have good clinical treatment effects, they still prevent women of childbearing age from entering a quasi menopausal state prematurely and the various serious side effects caused by long-term use, which still prevent patients from completely getting rid of the disease. Therefore, developing new clinical treatment strategies for endometriosis remains a top priority in current clinical drug research and development. EGFNASA capsules, as a new generation oral preparation independently developed by Ningbo Aikosol, adopt a unique molecular design and can simultaneously act on androgen receptors and cyclooxygenase targets in the body, inhibiting excessive estrogen while suppressing chronic inflammation, thus achieving the therapeutic effect of inhibiting pain and endometriosis. Due to its non steroidal structure, it can better improve the emotional life between couples while avoiding the side effects of male secondary sexual characteristics in androgens, completely avoiding the side effects of existing clinical drugs. The development of this drug not only meets the unmet clinical needs, but also reflects the innovative breakthroughs of domestic pharmaceutical companies in the field of gynecological diseases. The scientific evaluation of its preclinical safety and efficacy is the core link for Shandong Xinbo to leverage its technological advantages.


Collaborative innovation, jointly building a new line of defense for women's health
Ningbo Aikoso Pharmaceutical Technology Co., Ltd. is deeply engaged in the research and development of innovative drugs for gynecological diseases. The promotion of EGFNASA capsules is an important attempt to fill the treatment gap; As the "guardian" of preclinical evaluation, Shandong Xinbo will continue to leverage its technological advantages in the field of preclinical evaluation of drugs, such as cell therapy and targeted formulations, and work with more innovative pharmaceutical companies to address unmet clinical needs and promote the development of the pharmaceutical industry.

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