China's Modified New Drug Development Gains Momentum with Approvals of Long-Acting and Pediatric-Specific Formulations

　　【Pharmaceutical Network | Industry Dynamics] Recent news indicates that Jiangsu Aidea Pharmaceutical Co., Ltd. has received the "Notice of Approval for Drug Clinical Trials" issued by the National Medical Products Administration (NMPA). The company’s independently developed Class 2.3 improved new drug, ADC119 tablets, has been officially approved to commence clinical trials, intended for use as part of a complete regimen for the treatment of antiretroviral-naïve adult patients with HIV-1 infection.
 

It is reported that this approval marks a significant step for the company in leveraging its core innovative drug, Ainvovirine, to extend into combination formulations and establish a comprehensive anti-HIV product portfolio. The active ingredients of ADC119 tablets include Ainvovirine, Emtricitabine, and Tenofovir Alafenamide. Among these, Ainvovirine is a Class 1 new drug developed in China as an oral anti-HIV agent and functions as a non-nucleoside reverse transcriptase inhibitor (NNRTI), while FTC and TAF are nucleoside reverse transcriptase inhibitors (NRTIs).
 

In fact, in recent years, improved new drugs have become a core choice for the pipeline layout of many pharmaceutical companies due to their advantages such as controllable risks, short development cycles, and strong feasibility. Since 2026, numerous improved new drugs have been approved for clinical trials and market launch in China.
 

On July 1, the website of the National Medical Products Administration (NMPA) announced that Hybio Pharmaceutical’s Class 2.2 new drug, Liraglutide (H) Injection, had been approved for marketing. Liraglutide is a GLP-1 receptor agonist with multiple mechanisms, including glucose-dependent insulin secretion, protection of pancreatic β-cells, delayed gastric emptying, and appetite suppression. In the domestic market, four companies—Lianbang Pharmaceutical, Huadong Medicine, Tonghua Dongbao Pharmaceutical, and Chia Tai Tianqing Pharmaceutical—had previously launched generic versions of liraglutide.
 

On June 22, Changchun High-Tech announced that its controlling subsidiary, GenSci, had received the Drug Registration Certificate approved and issued by the National Medical Products Administration (NMPA). The application for marketing authorization of domestically produced Triptorelin Acetate for Injection (II) by GenSci was approved. This drug is classified as a chemical drug category 2.2 and is indicated for the treatment of central precocious puberty (CPP) in children weighing 20 kg or more.
 

On June 10, the improved new chemical drug Class 2.2—Paclitaxel for Injection (Albumin-Bound) (II), developed by CSPC Ouyi Pharmaceutical Co., Ltd., was approved for marketing by the National Medical Products Administration. It is reported that the approved indications for this drug are metastatic breast cancer after failure of combination chemotherapy and breast cancer relapsing within six months after adjuvant chemotherapy, with a focus on the treatment of clinically refractory and recurrent breast cancer. After its launch, it will further enrich the standardized treatment medication system for breast cancer in China and effectively reduce the medical and medication burden on patients.
 

On May 7, Chengdu Easton Bio Pharmaceuticals Co., Ltd. announced that its new chemical drug, Oxycodone and Acetaminophen Extended-Release Tablets (Class 2.2), had been successfully approved. This medication is indicated for the treatment of moderate to severe postoperative pain and should be used when patients cannot tolerate alternative treatments (such as non-opioid analgesics) or when such alternatives fail to provide adequate analgesia, necessitating opioid therapy. Earlier this year, the company had two improved new drugs approved: Chloral Hydrate Syrup and Oxycodone and Acetaminophen Extended-Release Tablets.
 

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Overall, since 2026, the majority of approved modified new drugs disclosed in China have been formulations focused on optimizing drug delivery methods or enhancing safety. Industry experts predict that, guided by policy and driven by market forces, China’s modified new drug industry will accelerate into a new stage characterized by “high-barrier, differentiated value creation.” This shift will not only impose higher requirements on enterprises but also unlock greater market potential.
 

　　Disclaimer: Under no circumstances shall the information contained herein or the opinions expressed constitute investment advice to any person.