Recently, Shandong New Era Pharmaceutical Co., Ltd., a subsidiary of Lunan Pharmaceutical Group, received marketing authorization notices from the National Medical Products Administration (NMPA) for six chemical active pharmaceutical ingredients (APIs) : doxorubicin hydrochloride, ibrutinib, pirfenidone, dronedarone hydrochloride, tetraenmenaquinone, and varenicline tartrate . These six APIs cover multiple therapeutic areas, including anti-tumor, anti-fibrotic, anti-arrhythmic, anti-osteoporosis, and smoking cessation. Specific information is as follows:

Doxorubicin hydrochloride belongs to the anthracycline antibiotic class and is a cell cycle-specific antitumor drug. Its clinical advantages lie in its broad antitumor spectrum and definite efficacy, and it is often used as a core drug in various combination chemotherapy regimens.

Ibrutinib is the first Bruton's tyrosine kinase (BTK) inhibitor, which is precise in targeting, convenient to take orally, has a long-lasting effect, broad indications, and controllable safety. It is a milestone drug in the history of B-cell malignant tumor treatment.

Pirfenidone is used for mild to moderate idiopathic pulmonary interstitial fibrosis. It has both anti-fibrotic and anti-inflammatory effects, which can significantly slow down the rate of decline in lung function, reduce the number of acute exacerbations, and prolong survival.

dronedarone hydrochloride is an antiarrhythmic drug whose clinical advantage lies in retaining its antiarrhythmic efficacy while significantly improving safety and reducing the risk of adverse reactions to thyroid function and lungs with long-term use. It is an important option for atrial fibrillation rhythm control.

Tetraene-menaquinone is a synthetic active form of vitamin K2, chemically identical to naturally occurring methylnaphthoquinone-4 (MK-4). Initially approved as a procoagulant, it was later shown to possess both bone-forming and bone-resorbing properties, making it an important clinical anti-osteoporosis drug. It also plays a positive role in maintaining bone density and preventing osteoporotic fractures in postmenopausal women and elderly men.

Varenicline tartrate is a selective partial agonist of the α4β2 subtype of nicotinic acetylcholine receptors. It is currently a widely used first-line smoking cessation drug in clinical practice. Its advantages lie in its strong targeting and definite efficacy. Compared with placebo and other smoking cessation therapies, it can significantly improve the long-term smoking cessation success rate.

The successful approval of these six active pharmaceutical ingredients (APIs) is a significant achievement for Lunan Pharmaceutical Group, demonstrating its deep commitment to R&D innovation and quality control. This not only enriches the company's API product line and fills gaps in related fields but also broadens the boundaries of its business layout, providing a continuous stream of resources for business expansion and market growth. The approval of these six APIs signifies that the company's R&D capabilities, production processes, and quality standards in these areas have reached advanced industry levels, enabling it to better meet the diverse market demands for various APIs. Furthermore, it lays a solid raw material foundation for the commercialization of the company's related pharmaceutical preparations, facilitating the rapid market launch and service to patients.

Lunan Pharmaceutical Group has always adhered to the working principle of "innovation-led and service-driven", taking R&D and innovation as the core driving force for enterprise development. It invests a lot of human, material and financial resources in the research and development and breakthroughs of new products and technologies, focuses on clinical needs, actively develops drugs with definite efficacy, high quality and low price, and strives unremittingly to achieve the grand goal of "Lunan Pharmaceutical, Healthy World".

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