On December 23, 2025 , the official WeChat account of Kingdaw Group announced that the β - nicotinamide mononucleotide ( NMN ) raw material produced by its wholly-owned subsidiary, Inner Mongolia Kingdaw Pharmaceutical Co., Ltd., had successfully completed the relevant compliance procedures of the U.S. Food and Drug Administration ( FDA ) regarding New Dietary Ingredient ( NDI ) and obtained an Acknowledgement Letter from the FDA .

Completing the above procedures enables Kingdaw's products to be legally marketed in the United States, and also provides a more solid foundation for Doctor 's Best, the company's US subsidiary , to resume and advance its NMN dietary supplement product portfolio.

It's worth noting that Kingway is not the only company to receive FDA approval. According to information from the domestic synthetic biology company Shangke Biotechnology, on December 2, 2025 , the FDA officially notified Shangke Biotechnology to reinstate its NMN raw material NDI , allowing its NMN raw material to be legally used as a dietary supplement ingredient in the US market.

Kingway defines itself as "a company driven by synthetic biology technology".

This positioning reveals its technological core that transcends traditional nutritional supplement companies. The company has established a complete technology transfer platform covering aspects such as targeted strain selection, precise fermentation control, bio-enzyme catalysis, and efficient separation and purification.

This technological platform directly supports its competitive advantage in core raw materials. For example, in the production of coenzyme Q10 , the company selects high-yield strains and uses advanced metabolic regulation and automated control technologies, achieving industry-leading fermentation yields and becoming the world's largest producer of coenzyme Q10 .

Similarly, the company uses microbial fermentation to produce physiologically active vitamin K2 and employs a green bio-enzyme catalysis process to produce NMN , with designed production capacity ranking among the top in the world. According to its 2025 semi-annual report, the designed and actual production capacity of its NMN series products is 500 tons each.

01
The Road to Clarifying the Regulatory Conundrum

The market 's focus on NMN is mainly on two aspects: firstly, changes in regulation.

It is understood that NMN , as a direct precursor of coenzyme I ( NAD+ ), has shown potential in cellular energy metabolism and aging-related research, making it a "star ingredient" in the field of dietary supplements.

However, its global compliance journey, especially in the US market, has been fraught with twists and turns.

In 2022 , the FDA raised questions about whether NMN was suitable for the dietary supplement regulatory framework based on relevant provisions of the United States Code, triggering the so-called "drug exclusion clause" controversy, which brought the related businesses of many companies, including Kingway, to a standstill.

The turnaround began with the sustained efforts of industry organizations.

In March 2023 , the Natural Products Association ( NPA ) and other organizations submitted a citizen petition to the FDA . After a lengthy legal and administrative process, the FDA officially responded on September 29 , 2025 , clarifying that NMN "is not excluded from the scope of regulations governing dietary supplements."

Against this backdrop, Chinese synthetic biology company Shangke Biotechnology announced in early December that its NMN raw material NDI had received reinstatement from the FDA , further confirming the opening of regulatory channels.

Kingdavi also quickly completed its own compliance procedures, which is of great significance to Doctor's Best , a well-known dietary supplement brand and an important U.S. subsidiary of Kingdavi.

According to reports, Doctor's Best has already begun to develop its NMN product portfolio, launching three differentiated formula products: NMN + CoQ10 ( 150 mg ), NMN+ ( 200 mg ), and NMN sustained-release ( 400 mg ), aiming to precisely meet the health needs of different consumer groups.

Artery Network learned during its research and interviews that NMN 's application for dietary supplement status in the United States had been rejected, not because of safety issues, but because of conflicts with regulations.

US regulations stipulate that if an ingredient is being developed as a drug, it cannot simultaneously be listed as a dietary supplement. NMN was approved before drug development began, but subsequent drug development led to a conflict in the application of regulations. The US Food and Drug Administration ( FDA ) recently reviewed this regulation, concluding that the clause was unreasonable and recognizing that NMN can exist as both a safe dietary supplement and a drug ingredient.

Therefore, around the end of September this year , the FDA officially reversed its previous decision, allowing NMN to have dual status as both a drug and a dietary supplement. This adjustment was based on an exception to the regulatory provisions, rather than a re-evaluation of product safety.

Regarding its prospects for approval in China, as of now, NMN has not obtained any licenses in China as a new food ingredient, food additive, health food, or drug. This means that NMN cannot be produced and sold in China as a regular food or health food.

In January 2021 , the State Administration for Market Regulation issued a letter requiring an investigation into the illegal sale of the " anti-aging drug " NMN .

Subsequently, the application for NMN as a food additive also encountered setbacks — it was accepted in January 2023 , but was included in the " not granted administrative license " list by the National Health Commission in May of the same year . Although there were reports in January 2025 that it had been included in the acceptance list again, the relevant announcements have since become unavailable.

Currently, the legal application of NMN in China is limited to cosmetics. Since January 2022 , several companies , including Fu'erjia, have completed the registration of NMN as a new ingredient in cosmetics.

Some experts believe that although NMN is unlikely to be approved for "anti-aging" effects in the short term, it may be approved for other effects in the future, provided that it is not advertised as "delaying aging" - because the efficacy of health products in China is limited to 27 types, of which delaying aging is not included.

02
A miracle cure for eternal youth? A medical miracle or a "scythe of low intelligence"?

Another point of focus is the debate over the efficacy of NMN .

In humanity's eternal yearning for youth and longevity, β - nicotinamide mononucleotide ( NMN ) was once hailed as a "miracle drug for immortality," igniting the enthusiasm of investors while also attracting cautious skepticism from top scientific journals.

The story begins in the halls of science.

In 2013 , a study brought NMN into the spotlight. David Sinclair 's team at Harvard University published a paper in the journal Cell, showing that NMN can be converted into NAD+ in the body ( NAD+ is involved in mitochondrial energy metabolism and DNA repair, and its level naturally declines with age).

Even more groundbreaking was a 2014 study: 22 -month-old mice supplemented with NMN showed significant improvement in mitochondrial function in their muscle cells, with "some indicators returning to levels seen at 6 months old." This is equivalent to "humans going from 80 years old back to their 20s ."

Since then, top journals such as Cell and Nature have published more than 2,000 related papers.

Capital has an extremely keen sense of smell, and the halo of science quickly translates into a commercial selling point. "Smart" pharmaceutical companies seized this trump card, rapidly launching their products as health supplements, focusing on anti-aging.

Among them, the most eye-catching "spokesperson" is none other than Li Ka-shing, the 96- year-old richest man in Hong Kong. According to reports, after taking health supplements containing nicotinamide nucleoside ( NR ), a "brother" ingredient of NMN , he exclaimed that he "felt like he was 20 years old again" and invested US$ 25 million (approximately RMB 200 million) in it.

Real estate tycoon Pan Shiyi also publicly supported it on Weibo.

With the endorsement of celebrities, health supplements containing NMN and NR instantly ignited the market, and were touted as the new generation of "longevity drugs" in China, causing prices to soar.

However, as the business boom surged, the regulatory attitudes showed a significant difference between China and the United States.

The regulatory differences between China and the United States have created a unique industrial landscape: China holds 90% of the world's NMN raw material production capacity, but the cautious regulatory attitude in China has put companies in a dilemma of "raw material export, finished product difficult to return".

Leading companies like Kingway and Yaben Chemical have had to rely on cross-border e-commerce to ship domestically produced raw materials to overseas factories for processing before "circuiting" back to China for sale. While Chinese companies have established an advantage in the upstream raw material supply chain, they still lag behind international giants in terms of branding and end-market access.

In addition, just as the commercial boom seemed to be unfolding, calm and even harsh voices from the scientific community cast a shadow over the craze.

Despite impressive animal testing data, the distance between the laboratory and clinical application is far greater than imagined. Throughout medical history, there are numerous examples of drugs that are highly effective in mice but fail or even cause side effects in human trials .

According to reports, as of October 2025 , only 19 NMN clinical trials have been registered globally .

A 2022 commentary published in *The Lancet Longevity* directly addressed three major problems in current NMN research: insufficient clinical evidence, unclear mechanism of action, and unknown potential risks. The article urged that NMN should not be promoted to the public as a "miracle drug" for anti-aging until sufficient clinical evidence is obtained .

Even stronger criticism came from authoritative scientific journals. A research team from the University of Copenhagen in Denmark published a review in Science Advances , a sub-journal of Science , evaluating 25 cutting-edge papers related to clinical trials of human NR supplements and giving a revolutionary conclusion: "There is almost no evidence of clinical efficacy!" Moreover, most of the researchers involved exaggerated or even misrepresented the data.

The study also revealed another hidden concern: even if NAD+ levels increase after supplementation (some studies have shown that the average concentration can double), because NR has a half-life of only about 3 hours, it is necessary to take large doses continuously to maintain the effect, which may be up to 7 times the recommended dose , and its safety is unknown.

Even more alarming is the fact that some overlooked studies suggest that improper supplementation may actually increase the risk of cancer and promote cancer cell metastasis. While NAD+ increases the energy of normal cells, it may also "make cancer cells grow faster."

Amid scientific debate and regulatory caution, the market is beginning to return to rationality. Market data confirms this predicament— ChromaDex , a company that received investment from Li Ka-shing, reported that sales growth of NMN- related products was far below expectations.

The story of NMN is far from over; it is essentially a contemporary microcosm of humanity's fight against the eternal question of aging.

It may be a promising scientific path, but it is far from a "miracle drug" that has reached its destination. Under the careful framework of regulation, rigorous scientific verification, and rational market choices, the truth about NMN is still on a long journey from laboratory to shelf, from animal to human, awaiting more time and the accumulation of evidence.

This controversy itself serves as a reminder that in the fields of science and health, cautious anticipation may be more valuable than fervent pursuit.

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