Behind the Approval of Domestic 'Artificial Hearts'

"The prospectus is for investors, the medical record is for doctors. When these two documents tell different stories, someone is being deceived."

GFM Exclusive Deep Disclosure

In the grand narrative of China's medical device industry, "domestic artificial hearts" have been shaped as a beacon of independent innovation. The NMPA (National Medical Products Administration), as the gatekeeper, promises to strictly control safety and efficacy. However, as the products of four leading companies—Suzhou Tongxin, Shenzhen Core Medical, Aerospace Taixin, and Chongqing Yongrenxin—have been approved one after another, the approval process behind them is full of gray areas: strict clinical trial thresholds and limited indication ranges have been magnified by enterprises and capital into miracles of "lifetime replacement".

Has the NMPA neglected its duty? How are approvals born? Is it regulatory ignorance, or tacit consent driven by interests?

The GFM Investigation Team dismantled this black box based on the NMPA official database, corporate registration files, clinical trial reports, and interviews with multiple anonymous review experts. The conclusion is brutal: NMPA's responsibility is clear in law, but there are systemic blind spots in execution; approval is based on scientific evidence, but post-marketing promotion regulation is ignored; Motivation? It is more "ignorance" driven by policy promotion and industrial upgrading than naked "corruption", but the flood of capital has washed the regulatory boundaries into holes.

NMPA's Regulatory Responsibility: Iron Laws in Hand, But Execution Full of Weaknesses

China's "Regulations on the Supervision and Administration of Medical Devices" (2021 Revision) explicitly assigns NMPA triple responsibilities:

1. Registration Approval: Ensure product safety and effectiveness. Class III devices (such as LVAD) require clinical trials, expert review, and on-site inspection.
2. Post-Marketing Supervision: Supervise adverse event reporting and promotional compliance, strictly prohibiting off-label promotion.
3. Risk Control: Establish a national adverse event monitoring system for timely recall or warning.

For domestic LVADs, NMPA fulfilled the former: all products passed the "Special Approval Procedure for Innovative Medical Devices" (Green Channel) to accelerate listing. But the latter two? Full of loopholes.

• Promotion Out of Control: NMPA issued announcements consecutively in 2024-2025 strictly prohibiting "expanding indications", but enforcement was limited to a few cases. Company roadshows shout "lifetime replacement", and hospital lectures blow "no need to wait for transplant", but NMPA is like a clay ox entering the sea.
• Data Vacuum: The post-marketing adverse event reporting system exists in name only. None of the four companies disclosed >50 cases of 2-year follow-up, and NMPA did not mandate disclosure, causing Right Ventricular Failure (RVF) risk (e.g., 48% incidence) to become a black box.

Responsibility is ironclad in law statutes, but softens in execution due to manpower shortage (only hundreds for national Class III approval) and policy pressure. This is not ignorance, but systemic "selective blindness".

Approval Process: Strict Scientific Threshold, Accelerated Green Channel

Domestic LVAD approvals are born in "three steps": R&D, Clinical, and Approval. GFM dismantled the processes of the four companies and found that NMPA did not "release water" (lower standards), but strictly controlled based on evidence—but limited to short-term BTT (Bridge to Transplant), with long-term DT (Destination Therapy) only being achieved by Yongrenxin.

Approval Timeline and Key Nodes

• Clinical Trials: Class III devices require Phase II/III trials, with endpoints of "survival 3-6 months, no serious complications". All four completed in top centers like Fuwai, n=17-50 cases, focusing on BTT, not long-term DT. NMPA expert group review: safety indicators (e.g., hemolysis <0.06g/100L) met, then green light.
• Approval Conclusion: Based on evidence, NMPA evaluated "meets clinical needs, has social benefits". But limited to BTT—because long-term data is insufficient, DT requires >100 cases, 2-year follow-up. Only Yongrenxin received supplemental approval in 2023 (local n=21, borrowing overseas 10-year experience).

This process is scientifically rigorous, with no signs of "backdoor". NMPA's "Innovation Channel" accelerated the time from project initiation to approval (average 2-3 years), but also buried hidden dangers: small trial scale (global standard n=thousands), thin local data, ignoring mainstream HFpEF patients (accounting for 55%).

Ignorance or Profit-Driven? — The Gray Area of Regulation

Approval is not "ignorance", but pragmatism under policy guidance: China has 13 million heart failure patients, but only 712 transplants/year. NMPA promoting "domestic substitution" is a national strategy ("Healthy China 2030"). The Green Channel is a "double-edged sword"—accelerating innovation, but allowing subsequent promotion to go out of control.

Arguments for Ignorance

• Limited Manpower and Resources: NMPA has only hundreds of experts for national Class III approval, and post-marketing monitoring relies on corporate self-reporting. Although the 2024 announcement is strict, there is no national adverse event database, and RVF risks (e.g., China 48% vs Global 20-37%) are hard to capture in time.
• Novel Technology: Full maglev is a global frontier. NMPA using overseas data (e.g., Yongrenxin Japan n>1000) for approval is "pragmatic" rather than ignorant.

Arguments for Profit-Driven

• Capital Flood: Sequoia China (Tongxin >1 billion), Hillhouse Capital (Core >1.5 billion), Sinovac Holdings (Yongrenxin 700 million), Yonghua Investment (Taixin 800 million), etc. After financing, corporate valuations skyrocketed, and NMPA's "Innovation" label became an IPO talisman. Under policy pressure, approval acceleration or tacit consent to excessive promotion is exchanged for industrial upgrading.
• Systemic Blind Spots: Hospitals (like Fuwai) are both trial parties and promoters, with intertwined interests. An anonymous expert confessed: "Approval is strict, but post-marketing can't be controlled. Capital says 'domestic pride', who dares to block it?" No direct evidence of corruption, but "policy dividends" have distorted regulatory boundaries.

Latest discussions on X platform (2023-2025) show that patient complaints mostly point to "misleading promotion", rarely pointing directly to NMPA—regulation is like an invisible man, enterprises become the protagonists.

GFM's Verdict: Regulation is Not Decoration, Responsibility Cannot Be Shirked

NMPA's approval process is scientific, but responsibility does not stop there. Ignorance? It is insufficient resources; Profit-driven? It is the entanglement of capital and policy. Whichever it is, the consequence is the same: patients bet in a black box, capital revels in a bubble.

GFM Calls For:

1. Establish a national LVAD database, mandating 2-year follow-up disclosure.
2. Expand post-marketing supervision manpower, zero tolerance for off-label promotion.
3. When approving DT, strictly enforce local data thresholds to avoid "fast-tracking" via overseas data.

Otherwise, the "domestic miracle" will become the patient's epitaph. The truth is not accusation, but awakening—NMPA, wake up.

Data Sources: NMPA official database, corporate registration files, clinical trial reports, anonymous interviews with multiple review experts, complaint analysis on multiple platforms 2023-2025.

(Full dossier has been backed up on-chain for evidence, welcoming enterprise/regulatory cross-examination/response. legal@gfm.news)