Jiuzhitang Debuts at Boao Lecheng's "Never-Ending" International Innovative Medical Device and Pharmaceutical Exhibition


来源:Excerpt from the WeChat official accounts of the Lecity Pilot Zone Administration and Jiuzhitang Group

2021-04-14

On the morning of April 13, the "Never-Ending" International Innovative Medical Devices and Pharmaceuticals Exhibition officially kicked off at the Boao Lecheng International Innovation Center for Medical Device and Pharmaceutical Exchange and Transformation!

This is the nation’s only long-term exhibition hall showcasing innovative global pharmaceuticals and medical devices. The current pharmaceutical and medical device expo has drawn 80 international innovator companies from 16 countries, bringing with them 810 pharmaceutical and medical device products to exhibit at the Conversion Center—among these, 441 products are not yet available in China, while 394 are making their domestic debut.

Opening ceremony venue

Over 600 leaders from China's National Medical Products Administration, relevant government departments in Hainan Province, along with academician experts and representatives from international innovative pharmaceutical and medical device companies, gathered in Lingshui to attend the opening ceremony. Together, they aim to establish Lingshui as a global hub for real-world data research—both in China and across the world—while driving China to take the lead in the application of clinical real-world data on an international scale.

Additionally, during the opening ceremony of the medical device exhibition, the National Medical Products Administration's Hainan Key Laboratory for Real-World Data Research and Evaluation was officially unveiled.

Hainan Provincial Standing Committee Member Fu Caixiang (right) and Gu Gang, Party Secretary and Director of the Lingshui Lijiang International Medical Tourism Pilot Zone Administration (left), unveiled the National Medical Products Administration's Key Laboratory for Real-World Data Research and Evaluation in Hainan.

Recently, the National Medical Products Administration (NMPA) issued the "Notice on Designating the Second Batch of Key Laboratories," announcing that Hainan's Real-World Data Research and Evaluation Key Laboratory has been officially recognized by the NMPA. As a result, China's first-ever key laboratory dedicated to real-world data research and evaluation has now established itself in Lingshui's Lecheng Pilot Zone. This milestone will provide robust technological support, positioning China at the forefront of global leadership in the application of clinical real-world data.

Currently, Boao Lecheng's real-world data research has led to the registration and launch of three products in China. Last year, the Hainan Provincial Medical Products Administration also announced the first batch of three pharmaceutical and medical device products—and a second batch of 11 medical devices—to begin pilot programs leveraging real-world clinical data.

The Jiuzhitang Group booth is located at No. 5 in the A13 section of the Traditional Chinese Medicine exhibition area. To deeply implement the important instructions of General Secretary Xi Jinping—to "bring TCM to the world"—this year’s medical equipment and pharmaceuticals expo has specially set up a dedicated TCM zone. This initiative not only provides a premier global platform for TCM enterprises to showcase their corporate culture and core products in a long-term, comprehensive manner but also helps companies align more closely with international standards, enhancing their visibility and reputation in overseas markets. Meanwhile, by fully leveraging the policy advantages of the Lecity Pilot Zone, the exhibition will facilitate real-world studies for innovative TCM products, paving the way for pioneering trials and accelerating the registration and launch of these groundbreaking offerings.

Jiuzhitang Exhibition Booth

The Jiuzhitang booth attracted attention from the news media.

As a century-old enterprise, Jiuzhitang leverages its strong expertise in the traditional Chinese medicine industry while tapping into cutting-edge international technologies. With independent innovation and capital-driven growth as its dual pillars, the company is proactively expanding into fields like regenerative medicine. Jiuzhitang strives to integrate China’s time-honored traditional medicine with the nation’s most advanced biotechnology, paving the way for an innovative future for this iconic Chinese pharmaceutical brand.

Rooted in product R&D, driving technological innovation

Innovation Platform

National-level R&D Platform 3 One; Hunan Province-level municipal R&D platform 4 One.

Patent Status

Apply for a patent 508 Case, Authorization 350 Case; Awarded 2 The China Patent Award.

Technology Project

Undertake science and technology projects 45 Items, including the National Ministry of Science and Technology Support Program, Major New Drug Development Initiative, and the 863 Project, among others. 16 Item: Received science and technology awards at or above the provincial/ministerial level 22 Item, including second-class or higher provincial and ministerial-level awards for scientific and technological progress 4 Item.

Innovative product

1) Re-evaluation of already-marketed products, focusing on repurposing existing drugs, exploring alternative uses for established medications, and reassessing the safe use of older drugs.

Re-evaluation Study of Shuxuetong Injection

Re-evaluation Study of Tianma Gouteng Granules

Sikang: Standard Enhancement and Process Modifications

……

2) Development of first-in-class innovative drug products, focusing on the creation of breakthroughs in treating major, challenging, and rare diseases to meet the public's medication needs.

REMD-477 : A groundbreaking antibody drug for treating diabetes—the world’s first clinically developed molecular targeting a G-protein-coupled receptor—has become the first glucagon receptor antibody approved by the FDA to enter clinical trials for diabetes.

LFG (YB209) A new anticoagulant drug designed to reduce the risk of bleeding addresses a critical technical challenge—namely, the severe hemorrhage risks associated with existing anticoagulants—resulting in significantly improved safety. The project has already secured 13 patent authorization certificates across seven countries. Following a dual regulatory filing strategy in China and the U.S., the company has now submitted a Pre-IND application to the U.S. FDA. On January 7, 2021, the FDA provided a written response, positively acknowledging the pharmaceutical, pharmacological-toxicological aspects, as well as the proposed clinical trial plan, while also offering several constructive recommendations. Meanwhile, on March 20, the seventh revision of the quality standards for the active pharmaceutical ingredient was completed, and the fourth version of the formulation guidelines was finalized. On April 2, the company submitted its Pre-IND application to the Center for Drug Evaluation (CDE) under China’s National Medical Products Administration.

YB211 : Cyclopeptide antibiotics that rapidly kill Gram-positive bacteria, exhibiting no cross-resistance with other antibiotics, and effectively eliminating bacteria in both the growth and stationary phases.

Stem cell therapy : Committed to accelerating the first-ever launch of stem-cell therapies in the domestic market.

Stem Cell Drug R&D Pipeline: China vs. U.S.

In February 2020, Jiuzhitang Maker’s Phase I/II clinical trial for ischemic stroke treatment using allogeneic human bone marrow-derived mesenchymal stem cells (it-hMSC) was approved. This approval marked three industry "firsts" in China’s stem cell drug sector: it became the first clinical trial to utilize imported stem cells; the first trial targeting a major neurological indication with stem cell therapy; and, following the National Medical Products Administration’s resumption of accepting applications for stem cell clinical trials, the first study to employ bone marrow-derived mesenchymal stem cells. The trial officially kicked off on January 12, 2021, and is currently being conducted at several hospitals, including Beijing Tiantan Hospital, Affiliated to Capital Medical University.

Moving forward, we hope to leverage the "first-mover advantage" and pioneering policies of the Lingshui Li'an Pilot Zone, along with its initiatives in real-world data research, to fast-track the launch of Jiuzhitang's innovative products in China. By doing so, we aim to deliver valuable health solutions and services to people worldwide, solidifying our position as the public’s top-choice health partner and ultimately contributing even greater value to human well-being!