China's First Dual-Target Weight-Loss Drug Shakes up the Global Market Landscape

A senior executive from a leading Chinese biopharmaceutical firm has announced the landmark approval of a new weight-loss treatment, highlighting a significant advance in a fiercely competitive global market.

The Production Director of China's Innovent Biologics, Inc. stated that Mazdutide, described as the world's first and only dual-targeted weight-loss drug to gain market approval, submitted its application for weight-loss indications in February last year and secured that approval in June this year. The company positions its unique dual-targeted design as a potential game-changer capable of 'disrupting' the international weight-loss drug market.

According to the company, the drug's post-launch performance has been spectacular, becoming a significant driver of revenue growth. This rapid journey from application to market was attributed to robust institutional mechanisms in Jiangsu province, where the company is based. These mechanisms focus on achieving breakthroughs across the entire industrial chain, thereby promoting the convergence of advanced production factors for developing what officials term 'new productive forces'.

The announcement comes as global competition in biopharmaceuticals intensifies, with new frontiers like cell and gene therapy and dual-target drugs continually emerging. Nevertheless, the industry still faces numerous innovation bottlenecks.

Tailored Government Support

Shen Xiaojie, Director of the Administrative Approval Division at the Provincial Drug Administration, explained the region's approach. He stated that in response to enterprises' practical needs, Jiangsu Province has pioneered a tailored support mechanism. This involves identifying the baseline status and gathering requirements for innovative drugs and medical devices.

For major innovative products like Mazdutide, dedicated service teams are formed. Experts visit production sites to conduct comprehensive assessments across multiple dimensions—including process design, cleanroom layout, and risk control-guiding enterprises in establishing stringent contamination prevention systems.

Mr Shen noted that the province also facilitated proactive communication between enterprises and China's National Medical Products Administration (NMPA), securing national endorsement for shared-line production protocols and clearing obstacles for rapid production line commissioning.

This reform is not a solitary advance but a systemic integration, pointing to a comprehensive reform spanning the entire chain from 'research and development-manufacturing-distribution-utilisation'.

A Parallel Case: Proton Therapy System

Another company, Mevion Medical Systems, received its regulatory 'good news' somewhat earlier. Late last year, its imported registration project, the 'Proton Therapy System', secured approval for market launch as a Class III innovative medical device from the NMPA.

The technology uses protons-positively charged particles-which halt cancer cell replication by destroying their DNA. Compared to photon radiotherapy, proton therapy offers superior precision. Mevion's system employs ultra-high-speed pencil beam scanning technology capable of switching energy layers within 50 milliseconds and delivering one-litre doses to tumour targets within six seconds. This concentrates radiation on the tumour while minimising damage to healthy tissue, enabling rapid, stable, and safe treatment for tumours near vital organs or those prone to movement.

However, its path to approval presented unique challenges. Unlike conventional medical devices, this ultra-large active medical equipment requires on-site assembly, commissioning, and testing at healthcare institutions. With no existing guidance for on-site inspections of such products, the regulatory path was unclear.

The Provincial Verification Centre, upon receiving the company's request, proactively reported to the NMPA's verification body and consulted inspection agencies in other provinces. A dedicated task force was established to provide liaison and follow-up services, eventually participating in drafting relevant inspection and verification regulatory documents to facilitate this 'groundbreaking achievement'.

A Systematised Approach to Innovation

The treatment afforded to Mazdutide and the proton therapy system is not an isolated case in Jiangsu. To date, Jiangsu's 'Innovative Pharmaceuticals and Medical Devices Consultation Service Interaction Platform' hosts 93 enterprises, covering 208 innovative pharmaceuticals and over 250 innovative medical devices.

Companies can submit queries regarding registration inspections online, with dedicated service teams responding within five working days. Drug projects that complete market authorisation applications may 'graduate' from the platform, while new projects continually join.

The diverse projects on the platform include original innovative drugs targeting previously unexplored international therapeutic areas, new 'life-saving drugs' for patients with recurrent or refractory tumours, and manual arthroscopic instruments providing orthopaedic surgeons with an 'extension arm'.

Under this 'targeted precision, end-to-end support' model, an increasing number of Jiangsu's innovative pharmaceuticals and medical devices are transitioning from laboratories to market, evolving from conceptual blueprints into clinical realities. This injects robust momentum into enhancing the province's core competitiveness in the biopharmaceutical sector and meeting the diverse health needs of its populace.