Firsekibart: The Emperor's New Clothes or a New Scam?

January 14, 2026

This article systematically reviews the historical scandals and penalties related to Changchun Jinsai Pharmaceutical (and its parent company, Changchun High & New Technology Industries Group) , and analyzes, based on existing publicly available information, the potential risk of exaggerated efficacy claims associated with its newly developed fosinocyclophosphamide (also known as "Jinbeixin").

I. Company Background Overview

Changchun Jinsai Pharmaceutical Co., Ltd. is a core subsidiary of Changchun High & New Technology Industries (Group) Co., Ltd. (hereinafter referred to as "Changchun High & New"), a large-scale biopharmaceutical company in China. It is mainly engaged in the research, development, production and sales of biopharmaceuticals, including a variety of innovative drugs and clinical drugs such as human growth hormone and follicle-stimulating hormone.

II. Historical Controversial Events and Penalty Records

1. International Litigation and Compliance Issues (2010)

Jinsai Pharmaceutical was sued for selling, marketing, importing, and distributing recombinant human growth hormone in the United States without FDA approval . The case was settled in a U.S. court. The company agreed to pay fines and related expenses, and also donated funds to establish a "Fair Competition Fund."

This indicates that it has encountered challenges in its compliance operations in the international market in the past, and such incidents are often accompanied by scrutiny of brand reputation and product compliance risks.

2. Controversy surrounding the "sales model" of growth hormone

Multiple media reports have pointed out that Jinsai Pharmaceutical has engaged in controversial practices in the marketing and sales of its growth hormone products, such as:

By partnering with specific medical institutions, drugs are sold in affiliated institutions outside of hospitals, leading to issues such as prescription referrals.
A court ruling has indicated that a certain cooperation model may violate relevant industry regulations (such as the Anti-Doping Ordinance) due to its direct supply of peptide hormone products to specific organizations.

Although these disputes are civil/compliance in nature, they highlight the risks for companies in terms of product promotion channels and standardized sales.

3. Historical disputes involving related parties that were not fully disclosed (at the Changchun High-tech Industrial Development Zone level)

According to publicly available information from Changchun High & New Technology Industries Group, another subsidiary of the company, Huakang Pharmaceutical, was investigated by the public security authorities for changing its production process without obtaining approval as required, which resulted in changes to the drug formula (although no prosecution was ultimately initiated). However, the company did not disclose this investigation process in a timely manner.

Although not directly targeting Jinsai Pharmaceutical, it shows that there are historical controversies regarding information disclosure and compliance governance at the group level.

4. Landmark events in the vaccine industry (different company from Jinsai Pharmaceutical)

It needs to be clarified that the "Changchun vaccine incident" well-known to the public mainly involves another company— Changchun Changsheng Biotechnology Co., Ltd. —not Changchun Jinsai Pharmaceutical Co., Ltd. However, due to similar locations and names, confusion often arises.

The company was fined approximately 9.1 billion yuan (about 1.3 billion US dollars) and had its production license revoked for falsifying rabies vaccine production records, using expired materials, and falsifying data. Its senior executives were also banned from the industry for life.

This incident has long been a landmark case of strengthened regulation in China's pharmaceutical industry, but it belongs to a separate company and cannot be directly attributed to Jinsai Pharmaceutical or Changchun High & New Technology Industries Group. The public and media's inaccurate confusion between the two names is a common misinterpretation.

III. Introduction to Firsekibart

(“Jinbeixin”)

Firsekibart (trade name "Jinbeixin") is an anti-IL-1β monoclonal antibody independently developed by Jinsai Pharmaceutical.

This drug was recently (in 2025) approved for marketing by the National Medical Products Administration of China for the treatment of acute attacks of gouty arthritis in adults. It is the first IL-1β antibody drug approved in China.
According to the manufacturer's publicity and internal releases, clinical data claims that it can significantly reduce the risk of gout recurrence (such as reports mentioning "reducing the risk of recurrence by 87% in six months").

The launch of this type of biopharmaceutical marks the progress of companies in innovative drug research and development.

IV. Evaluation of Technology and Market Effects: Is there a possibility of exaggerated effects?

After objectively analyzing the currently available information about voxincibazin, we can assess the probability of "exaggerated efficacy" from the following perspectives:

Is the clinical evidence transparent and publicly available?

Currently, publicly available information mainly comes from company announcements and some media reports; no independently published, complete Phase III clinical trial data (such as formal papers in international medical journals) has been found . This lack of transparent data makes it difficult for the third-party scientific community to prudently verify the actual efficacy of the treatment.

Scientific rigor in promotional language

Businesses or media outlets sometimes use catchy slogans (such as "will become the largest single product" or "significantly superior to previous treatments") to shape market expectations. These slogans have a certain marketing flavor and are not equivalent to rigorous scientific conclusions.
In the absence of complete data for comparison, extending the efficacy of a treatment to groups with non-approved indications or those not verified by controlled trials increases the risk of "exaggerated efficacy" assessments.

Industry competition and patient expectations

Innovative antibody drugs are inherently expensive and have high market expectations. For patients with inflammatory diseases such as gout, if other treatments already exist, it is difficult to determine whether a drug is truly "superior to similar drugs worldwide" based solely on company claims without independent clinical data validation.

V. Overall Conclusion

✅ Jinsai Pharmaceutical has indeed had compliance controversies and penalties in its history.

Encountering compliance litigation in international markets;
There are legal and industry regulatory controversies regarding the sales model of growth hormone.
There have also been controversial incidents regarding the information disclosure of the parent group.

This does not mean that the current product itself is invalid, but it suggests that it needs to strengthen transparency and standardized management in terms of compliance and corporate governance.

⚠️Regarding the promotional claims for the efficacy of

Firsekibart Baymall.

The drug has been approved by the state;
However, the currently available clinical data lacks comprehensive public verification;
Corporate or media promotions may have a marketing element and may involve exaggeration , especially when there is a lack of independent scientific research publications, so caution is advised.

Therefore, from a scientific and patient-interest perspective, it is recommended to focus on publicly available clinical data and authoritative medical evaluations , rather than relying solely on corporate promotional statements, and to carefully assess the efficacy of drugs.