Entrusted by the Publicity Department of the CPC Central Committee and sponsored by Xinhua News Agency, the magazine "Half Moon Talk" published a long article on August 7 titled "The ‘Table-Entering Moment’ of Chinese Innovative Drugs". The report starts with the approval of Cilobol by the US FDA, and explores Chinese innovative drugs through three aspects: putting "precision navigation clothes" on the drugs, gaining global trust, and adopting international thinking in advance.

The report states: “Cycloheximide acts like a mirror, reflecting the exploration and breakthroughs of Chinese innovative drugs from ‘following’ to ‘running alongside’, and even achieving ‘leading’ in specific fields.” The original text is reproduced here for readers.

Half Moon Talk | The "table presentation" moment of Chinese innovative drugs

Recently, Cibophen injection, a class 1 intravenous anesthesia innovation drug independently developed by Hisiko Pharmaceutical Group, has been officially approved for marketing by the US Food and Drug Administration (FDA) for the indication of general anesthesia induction in adults. This is not only China's first international intravenous anesthesia original research innovation drug, but also the first new type of intravenous anesthetic to be approved for market after decades of inactivity in the global anesthesiology field.

Cycloheximide acts like a mirror, reflecting the exploration and breakthroughs of Chinese innovative drugs from "following" to "running alongside," and even achieving "leading" in specific fields.

Weave a “precise navigation suit” onto the medicine

Anesthesiologists are known as "guardians of life," and anesthetic drugs are the sharpest and most dangerous "weapons" in their hands. "I have seen a little girl who hid her hand as soon as she entered the operating room due to multiple surgeries, because she was afraid of the pain of injections," said Zuo Yunxia, a chief physician at the Anesthesiology and Surgery Center of West China Hospital of Sichuan University, regarding the psychological trauma caused by the pain of propofol injections to patients, especially children, in clinical practice.

The development and research of cyclopellin directly addresses clinical challenges. The Haisco technology team did not focus on simple formulation improvements orProdrug DevelopmentInstead of a straightforward approach, they chose the more challenging “underground innovation” – structural modification of molecular structures. Starting with the propofol molecule, they filtered out hundreds of compounds to select candidate drugs that underwent modification by introducing “chiral cyclopropyl” groups.

This clever chemical adjustment gives the drug a “precise navigation suit”, enabling it to retainPropofolWith the advantages of rapid onset and quick recovery, optimization is achieved in receptor selectivity and pharmacokinetics. Clinical data confirm the improved results: the incidence of injection pain is significantly reduced, there are fewer respiratory depression and cardiovascular adverse reactions, and the circulation is more stable... This indicates a substantial improvement in clinical safety.

How to win global trust

When submitting the new drug clinical trial application to the FDA, Hisicor faced significant challenges. "We surveyed 25 centers in the US over 3 months, but only one agreed to participate," recalled Wu Nan, deputy general manager of Hisicor Pharmaceutical Group. Geopolitical factors, cross-border management costs, and a unfamiliar clinical environment were all obstacles.

The final stage was successfully completed. Based on clinical data of cyclobutanol in China and Australia, the FDA directly exempted Phase I and Phase II clinical trials, allowing it to proceed directly to key Phase III trials.

Yang Mengchang, director of the Clinical Trial Center at Sichuan Provincial People's Hospital, is a witness to the clinical research of cyclopentolate. He keenly noticed that cyclopentolate might be superior to propofol in circulatory stability. Therefore, the team followed US approval standards and conducted clinical studies covering almost all scenarios of intravenous anesthesia, such as anesthetic induction, maintenance, ICU induction, and ICU maintenance, so that "the Americans cannot raise any questions".

Dou Ying, the deputy general manager of R&D at Hisicor Pharmaceutical Group, concluded that the key to gaining FDA recognition lies in two aspects: first, cyclobutanol itself addresses unmet clinical needs; second, the entire quality system meets international standards, and the data is genuine and reliable.

Prerequisite international perspective

Currently, China's innovative drugs entering international markets are at a critical stage of transitioning from quantitative growth to qualitative improvement. The transaction value in the first half of 2026 is approximately ten billion US dollars.

From early export of generic drugs, to later licensing agreements, and now to the "self-declaration + partner collaboration for commercialization" model adopted by cyclobutanol, Chinese pharmaceutical companies are becoming more diverse on their internationalization path. "In the past, we would talk about cooperation with the US, and they would often only express interest politely. But now, China's core assets have made it onto the stage, and even taken a prominent position," Wu Nan said.

For innovative pharmaceutical companies, an international mindset must be established from the beginning. From the initial stage of project initiation, research plans should be designed according to standards for both Chinese and American submissions, or even global applications, rather than focusing on domestic efforts before considering overseas markets. It is essential to maintain frequent and high-quality communication with regulatory authorities to deeply understand international standards. A internationalized quality system must be established. This is the foundation, as well as the confidence to cope with challenges such as geopolitics and data scrutiny.

How to choose the right overseas commercial partner? How to achieve value return in the complex international payment system? How to address potential intellectual property risks? How to reinvest global profits into domestic research and development? The challenges of going global remain.

Yan Pangke, General Manager of Hisicor Pharmaceutical Group, said that biomedicine has been listed by the country as a new pillar industry, and the efficiency of review and approval has greatly improved. He hopes that in the future, more policy support will be provided in areas such as regulatory mutual recognition (such as GMP systems) and diverse payment systems (such as commercial insurance), to help Chinese innovative drugs better "go global".

Source: Xinhua News Agency's Half Moon Talk