Independently designed multi-dose blister DPI achieves equivalence to the reference product in a head-to-head Phase III study and enters commercial supply

Highlights

■    China’s NMPA has approved Chia Tai Tianqing’s Suhuan®, the country’s first generic umeclidinium/vilanterol inhalation powder, which uses Singmed’s Shumaitian device

■    Shumaitian is independently designed, structurally distinct from the reference ELLIPTA® device and protected by Singmed’s own intellectual property

■    Singmed will supply the device for commercial launch; its devices support more than 30 drug–device programs in China, the U.S. and Europe

SUZHOU, China, Oct.22nd, 2026 - Singmed, a developer and manufacturer of inhalation and nasal drug delivery devices, today announced that its Shumaitian multi-dose blister dry powder inhaler (DPI) has been approved in China as part of Suhuan® (umeclidinium/vilanterol inhalation powder), a treatment for chronic obstructive pulmonary disease (COPD) developed by Chia Tai Tianqing Pharmaceutical Group (CTTQ), a subsidiary of Sino Biopharmaceutical Limited (HKEX: 1177). China’s National Medical Products Administration (NMPA) published the approval on Oct. 22.^[1]

Suhuan® combines a long-acting muscarinic antagonist (LAMA) with a long-acting beta2-agonist (LABA). According to CTTQ, it is the first domestically developed version of the product approved in China to have completed a head-to-head Phase III study against the reference product, GSK’s ANORO® ELLIPTA®.^[2] Data provider Pharnex identifies it as the first generic of the product in China, a market the originator served alone in 2025, with sales of nearly RMB 1 billion (about US$140 million).^[3]

Figure 1  Singmed’s Shumaitian multi-dose blister DPI, approved in China as part of Suhuan® (actual product photo, Singmed-branded version).

Different Structure, Equivalent Product

The device is often the hardest part of developing a generic inhaled medicine. Reference products are typically protected by long-lived patents; GSK has disclosed that U.S. patents and exclusivities for ANORO® ELLIPTA® extend to 2031.^[4] A generic product therefore needs an independently designed device with freedom to operate (FTO) that still performs equivalently to the reference product.

Singmed developed Shumaitian with a structure and operating mechanism that differ from those of the ELLIPTA® device and conducted an FTO analysis during development, as it does for every program. Both the device design and its manufacturing processes are protected by Singmed’s own intellectual property. Device design and formulation work proceeded in parallel, and the program demonstrated human factors consistency, in vitro equivalence and pharmacokinetic bioequivalence (PK-BE).

Head-to-Head Phase III Results

In the multicenter, randomized, open-label Phase III study (TQC3403-CS-01; ChiCTR2600120078), 414 patients with moderate-to-severe COPD at 56 sites in China received either Suhuan® delivered by the Shumaitian device or the reference product. After 24 weeks, the least-squares mean difference between groups in change from baseline in trough FEV₁, a key measure of lung function, was 16 mL (95% CI: −30 to 62 mL), within the prespecified equivalence margin of ±70 mL. The study met its primary endpoint, and safety profiles were similar between groups. The results were presented at the European Respiratory Society (ERS) International Congress 2025 and published in the Journal of Thoracic Disease in July 2026.^[2][5]

Commercial Supply

Singmed will supply Shumaitian for the launch of Suhuan® from its company-owned site in Changshu, near Shanghai, which began operations in August 2024 and has a planned annual capacity of 50 million units. Device design, in vitro testing, precision tooling, cleanroom molding, silicon microfluidic chip fabrication and automated assembly are all performed in-house. The site is certified to ISO 13485 and ISO 15378, and its quality system is designed in line with NMPA, FDA and EMA requirements.

Figure 2  Singmed’s company-owned R&D and manufacturing site in Changshu, near Shanghai (actual site photo).

A Platform for Global Partners

Beyond Suhuan®, Singmed’s devices are in development or supply for more than 30 drug–device combination products, nearly 10 of which have successfully completed PK-BE, PD-BE or Phase III studies under NMPA or U.S. FDA pathways. Customers include leading Chinese and multinational drugmakers, with programs in clinical development or registration in China, the U.S. and Europe, spanning generics, 505(b)(2) products and novel drugs. Singmed’s DPI devices also support novel inhaled candidates targeting PDE3/4 and PDE4B for COPD and pulmonary fibrosis; one has reported positive Phase II topline results, and another has received Investigational New Drug (IND) clearance from the U.S. FDA.

“This approval shows that an independently designed device can deliver a product equivalent to the reference and be manufactured consistently at scale,” said Albert Zhao, Chairman of Singmed. “Many companies can build a prototype. The real test is delivering the same performance through clinical development, registration and commercialization. We look forward to working with pharmaceutical partners worldwide to bring more inhaled medicines to patients faster.”

About Singmed

Singmed (Suzhou Singmed Medical Device Science and Technology Ltd.) designs and manufactures drug delivery devices for pharmaceutical companies worldwide. Its four technology platforms cover dry powder inhalers, soft mist inhalers, pressurized metered-dose inhalers and nasal delivery systems, and the company also develops on-body subcutaneous delivery and wearable devices. Founded in 2016 and headquartered in Suzhou, China, Singmed has approximately 350 employees, a company-owned manufacturing site in Changshu, and 256 granted patents and 150 pending patent applications. It is backed by U.S. and Singapore-based venture capital investors and Chinese institutional investors. For more information, visit www.singmed.cn.

Forward-Looking Statements

This press release contains forward-looking statements, including statements about commercial supply, product development and regulatory progress. These statements are based on current expectations and involve risks and uncertainties that could cause actual results to differ materially. Singmed undertakes no obligation to update them, except as required by law.

Trademarks

ANORO and ELLIPTA are registered trademarks of the GSK group of companies. Suhuan is a trademark of Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Contacts

Media Inquiries: media@singmed.cn

Business Inquiries: business@singmed.cn

References

[1] National Medical Products Administration (NMPA), Drug Approval Certificate Delivery Information, Oct. 22, 2026

[2] Chia Tai Tianqing (CTTQ) official WeChat account, announcement of Suhuan® approval, Oct. 23, 2026

[3] Pharnex, Oct. 23, 2026: https://mp.ofweek.com/biotech/a356714977687

[4] GSK Annual Report 2025, p. 288: https://www.gsk.com/media/kn0bknmd/annual-report-2025.pdf#page=288

[5] Journal of Thoracic Disease, July 2026; ChiCTR2600120078: https://jtd.amegroups.org/article/view/121006/html