JinDaWei's NMN Ingredient Clears FDA Hurdle: Scientific Breakthrough or Capital Play?
Kingdomway
Health Product Manufacturer
2025Year12Month23Recently, the official WeChat account of Kingdomway Group announced that,β produced by its wholly-owned subsidiary, Inner Mongolia Kingdomway Pharmaceutical Co., Ltd.-Nicotinamide Mononucleotide (NMN) The raw materials have successfully completed the U.S. Food and Drug Administration (FDA) Regarding New Dietary Ingredients (New Dietary Ingredient，NDI) relevant compliance procedures, and obtainFDAIssued Confirmation Letter (Acknowledgement Letter）。
Completion of the aforementioned procedures has enabled Kingdomway’s related products to meet the compliance requirements for sales in the U.S. market, while also providing its U.S. subsidiary Doctor’s Best Recovery and AdvancementNMNThe dietary supplement product portfolio provides a more solid foundation.
Notably, Kingdomway is not the only one to have obtainedFDArecognized enterprises. According to information from Shangke Biological Medicine, a domestic synthetic biology enterprise,2025Year12Month2Day,FDAOfficial Notice: Resumption of Shangke Biological MedicineNMNRaw MaterialsNDI, allowing its production ofNMNThe raw material is legally used as a dietary supplement ingredient in the U.S. market.
Kingdomway defines itself as “a company driven by synthetic biology technology.”
This positioning reveals its technological core, which transcends that of traditional nutritional supplement companies. The company has established a comprehensive technology translation platform covering key processes such as targeted strain selection and breeding, precise fermentation control, biocatalysis with enzymes, and high-efficiency separation and purification.
This technology platform directly underpins the competitive advantage of its core raw materials. For example, in coenzymeQ10ProductionThe Company selects high-yield strains and employs advanced metabolic regulation and automated control technologies, achieving fermentation unit yields that are at the industry-leading level.Currently has become the global coenzymeQ10The largest manufacturer.
Similarly, the company employs microbial fermentation to produce physiologically active vitamins.K2, produced using a green biocatalytic processNMN, with design production capacity ranking among the top globally. According to2025Semi-Annual Report Information,ItsNMNThe designed production capacity and actual production capacity of the series products are both500tons.
01
Clarifying the Regulatory Maze
Market forNMNThe focus is primarily on two aspects, one of which is regulatory changes.
It is understood that,NMNAs a coenzymeI（NAD+) as a direct precursor, demonstrating potential in research on cellular energy metabolism and aging-related processes, thereby establishing it as a “star ingredient” in the dietary supplement sector.
However, its path to global compliance, particularly in the U.S. market, has been fraught with twists and turns.
2022Year,FDAPreviously, in accordance with the relevant provisions of the United States Code,NMNraised questions about its applicability to the dietary supplement regulatory framework,Triggered the so-called “drug exclusion clause” controversy, causing business operations related to this matter at numerous companies, including Kingdomway, to come to a standstill.
The turnaround began with the sustained efforts of industry organizations.
2023Year3Month, the Natural Products Association (NPA) and other institutions toFDASubmission of a Citizen Petition. After protracted legal and administrative communications,FDAat2025Year9Month29officially responded on the day,Clear ClarificationNMN“Not excluded from the scope of application of regulations related to dietary supplements.”
In this context, the Chinese synthetic biology enterprise Shangke Biological Medicine12announced at the beginning of the month itsNMNRaw MaterialsNDIAcquisitionFDARecovery further validated the opening of the regulatory channel.
Kingdomway has also rapidly completed its internal compliance procedures, with regard to its important U.S. subsidiary and well-known dietary supplement brandDoctor's Bestthis development is of great significance.
According to reports, currentlyDoctor's BestInitiatedNMNProduct portfolio, launchedNMN + CoQ10（150 mg）、NMN+（200 mg）、NMNSustained-release (400 mg) Three differentiated formula products, designed to precisely meet the health needs of different consumer groups.
VCBeat learned through research interviews that previouslyNMNThe application for dietary supplement status in the United States was previously rejected,However, the reason is not due to safety concerns, but rather stems from conflicts in regulatory provisions.
U.S. regulations stipulate that if an ingredient has been developed as a drug, it cannot simultaneously be classified as a dietary supplement.NMNApproved prior to the initiation of drug development, but subsequent drug development processes led to contradictions in regulatory applicability. The U.S. Food and Drug Administration (FDA) Recently, this regulation has been re-examined, and it is considered that this clause is unreasonable, recognizingNMNIt can serve both as a safe dietary supplement and as an active pharmaceutical ingredient.
Therefore,FDAthis year9Around the end of the month, the previous decision was officially reversed, allowingNMNIt holds the dual status of both a drug and a dietary supplement. This adjustment is based on an exceptional approval under regulatory provisions, rather than a re-evaluation of the product’s safety.
Regarding the approval prospects in China,As of now,NMNIt has not yet obtained approval in China as a novel food ingredient, food additive, health food, or drug, which means thatNMNIt shall not be produced or marketed in China as ordinary food or health food.
2021Year1In [Month], the State Administration for Market Regulation issued a letter requesting an investigation into illegal business operations.“Elixir of Life”NMNbehavior.
Thereafter,NMNFood additive applications have also encountered setbacks——2023Year1accepted in [Month], same year5month was included in the list by the National Health Commission“Non-approval of Administrative License”List. Although2025Year1In [Month], it was reported that the company had been re-listed on the acceptance list, but the relevant announcement subsequently became unavailable for query.
Currently,NMNIn China, the legally approved application is limited to cosmetics.Self2022Year1Since [Month], multiple companies, including Fu Er Jia, have completedNMNFiling as a New Cosmetic Ingredient.
Some experts believe that, althoughNMNIt is difficult to obtain approval for “anti-aging” claims in the short term, but other indications may gain regulatory approval in the future, provided that claims of “delaying aging” are not made—since the permitted health benefits of dietary supplements in China are limited to27species, excluding those that delay aging.
02
Elixir of Youth? A “Medical Miracle”or“IQ Sickle”
Another area of concern lies inNMNThe Debate Over Efficacy.
In humanity's eternal quest for youth and longevity, β-Nicotinamide Mononucleotide (NMN) Once hailed as the “elixir of youth,” it ignited investor enthusiasm while also drawing cautious skepticism from top scientific journals.
The story begins in the temple of science.
2013In [year], a studyNMNthrust into the spotlight. Harvard University’sDavid SinclairThe team published a paper in the journal Cell, indicating thatNMNCan be converted in vivo intoNAD+（NAD+Participates in mitochondrial energy metabolism andDNArepair, the level of which naturally declines with age).
Even more sensational is2014Years of Research:22-month-old aged mice supplemented withNMN, mitochondrial function in muscle cells was significantly improved,“Certain indicators return to6levels at months of age.” Equivalent to “humans from80years returned to20“years old”.
Thereafter, 《Cell》《Nature》and other top-tier journals, with a cumulative total of over2000relevant papers.
Capital has an extremely keen sense of smell, and the halo of science is quickly transformed into a commercial selling point. "Smart" pharmaceutical companies have seized this trump card, rapidly launching it on the market in the form of health supplements, with a focus on anti-aging.
Among them, the most eye-catching “spokesperson” is none other than96-year-old Chinese billionaire Li Ka-shing. According to reports, after taking a supplement containingNMN"Brother" ingredient nicotinamide riboside (NR) health supplements, exclaimed, "It feels like I've returned to20years old,”and made a one-time investment for this purpose2500ten thousand US dollars (approximately2hundred million yuan).
Real estate tycoon Pan Shiyi also voiced his support for him on Weibo.
Under the influence of celebrity endorsement, includingNMNandNRhealth supplements instantly ignited the market, being hailed in China as the new generation of “longevity drugs,” with prices soaring.
However, as the commercial boom surged, regulatory attitudes revealed a striking disparity between China and the United States.
Regulatory Divergence Between China and the US Has Shaped a Unique Industrial Landscape:China Holds the Global90%ofNMNRaw material production capacity, yet the cautious regulatory stance in China has trapped enterprises in a dilemma of “exporting raw materials but struggling to bring finished products back.”
Leading enterprises such as Kingdomway and Yaben Chemical have had to resort to cross-border e-commerce, shipping locally produced raw materials to overseas facilities for processing before “circling back” for sale in the domestic market. Although Chinese companies have established advantages in the upstream supply of raw materials, they still lag behind international giants in terms of branding and end-market presence.
Moreover, just as the commercial feast appeared to be unfolding, calm and even stern voices from the scientific community cast a shadow over this frenzy.
Despite the impressive data from animal experiments, the journey from the laboratory to clinical application is far more distant than imagined. In medical history, drugs that have shown significant efficacy in mice, inHuman Clinical TrialsCases of treatment failure or even adverse effects are commonplace.
It is reported that as of2025Year10month, globally registeredNMNClinical Trials Only19Example.
2022The commentary published in The Lancet Healthy Longevity this year pointed directly at the currentNMNThree Major Issues in Research: Insufficient Clinical Evidence, Unclear Mechanisms of Action, and Unknown Potential Risks. The article calls for refraining fromNMNPromoted to the public as a “miracle drug” for anti-aging.
More intense scrutiny has come from authoritative scientific journals. A research team from the University of Copenhagen in Denmark"Science"Sub-journal 《Science Advances》published a review article evaluating25Articles & HumansNRFrontier Literature on Supplement Clinical Trials Yields Groundbreaking Conclusions:“There is hardly any evidence of clinical efficacy!” Moreover, most relevant researchers have been found to exaggerate or even falsify data.
The study also revealed another hidden concern: even after supplementationNAD+Level enhancement (trials have shown that the average concentration can be doubled), but due toNR's half-life is only about3hours, requiring continuous high-dose administration to maintain efficacy, which may reach the recommended dosage's7times, with its safety unknown.
Even more alarming is that some overlooked studies suggest,Improper supplementation may instead increase the risk of cancer and promote cancer cell metastasis.NAD+While boosting energy in normal cells, it may also “cause cancer cells to grow faster.”
Amid scientific controversy and regulatory prudence, the market is also returning to rationality. Market data corroborates this predicament—backed by Li Ka-shing’s investment,ChromaDexThe company, whose financial statements showNMNSales growth of related products fell far short of expectations.
NMNThe story is far from over; it is, in essence, a contemporary microcosm of humanity’s eternal struggle against aging.
It may represent a promising scientific avenue, but it is by no means a “miracle drug” that has reached the finish line. Under the prudent framework of regulation, rigorous scientific validation, and rational market selection, regardingNMNThe truth remains on the long journey from laboratory to shelf, and from animals to humans, awaiting further accumulation of time and evidence.
This controversy itself serves as a reminder that in the realms of science and health, cautious expectation may be more valuable than fervent acclaim.
Supplementary Reading:
Kingdomway’s Synthetic Biology Industry Layout
Although existing materials do not separately disclose KingdomwayNMNfinancial data of the business, but the company's overall performance growth and the strong performance of the health supplements segment have provided support for its expansion into new categories.
2025Company revenue in the first half of the year17.28100 million yuan, a year-on-year increase of13.5%; Net profit attributable to shareholders of the parent company2.47hundred million yuan, a significant year-on-year increase90.1%; in the first three quarters, the Company achieved operating revenue26.04billion yuan, a year-on-year increase of11.16%, net profit3.61100 million yuan, a year-on-year increase of63.47%。
under its umbrellaDoctor's BestBrand in2025Year"618“Omni-channel Sales Growth During the Promotion Period”70%, which to some extent demonstrates its brand operation and channel capabilities.
Kingdomway’s strategy extends far beyond raw material production. Through years of organic growth and overseas mergers and acquisitions, the company has established an “upstream raw material production-Midstream Formulation R&D and Manufacturing-“Downstream Brand Marketing and Channels” Full Industry Chain Layout.
Upstream Raw Material Sector: The company is a global coenzymeQ10The largest manufacturer, also a vitaminA、D3, Algal OilDHAVitaminsK2、NMN...and other series of raw materials. Its raw material capacity table shows that coenzymeQ10Designed production capacity after expansion reaches920Ton/Year,NMNDesign Capacity500ton, VitaminASeries Design Capacity4000tons, etc., with significant scale advantages.
Midstream Production: U.S. SubsidiaryVitaBestThe factory provides manufacturing services for nutritional supplements in the form of capsules, tablets, and powders, with a softgel capsule production line currently under construction. This ensures autonomous control and quality stability throughout the entire manufacturing process, from core raw materials to finished products.
Downstream Brands and Channels: The company has acquiredDoctor's Best(Dotbase),Zipfizz、Viactiv、RxSugara brand portfolio covering various niche segments such as dietary supplements, energy drinks, chewable tablets, and sugar substitutes. In terms of sales channels, overseas markets are served throughCostco、Sam's Club、Amazon、iHerbsold through online and offline channels; in China, brand operations are mainly conducted via cross-border e-commerce platforms such as Tmall Global, JD Worldwide, and Douyin.
This vertically integrated model can, in theory, deliver significant synergies: raw material advantages ensure product quality and cost control, brand operations directly reach consumers and capture market premiums, and distribution networks guarantee product circulation.
A research report by Tianfeng Securities believes that this makes KingdomwayBterminal raw materials andCpossesses competitive advantages in the high-end health food sector.
Despite its grand strategic layout and prominent advantages, Kingdomway’s synthetic biology-driven path still faces several visible challenges and risks.
On one hand, there are risks associated with technological and market iteration. Although synthetic biology technology serves as the foundational support, the lifecycle and market popularity of specific products can change. The company's current performance relies on coenzymeQ10, VitaminsAHigh dependence on blockbuster products.NMNAlthough new raw materials have promising prospects, uncertainties remain regarding their ultimate market acceptance, the competitive landscape, and the potential emergence of next-generation alternative technologies.
On the other hand, it lies in the complexity of post-merger integration and brand management. The company has rapidly built a brand matrix through multiple overseas acquisitions. However, multi-brand (Doctor's Best, Zipfizz, Viactiv, RxSugar) synergistic management, clear differentiation in brand positioning, and the effectiveness of cross-cultural integration constitute a long-term test of managerial capabilities.
Another factor is the volatility of the market and regulatory environment: The nutritional health supplement industry is significantly influenced by policies and regulations. AsNMNWhat the experience in the United States demonstrates is that shifts in regulatory winds can directly determine the survival or demise of a product, or even an entire business line.
Furthermore, capacity expansion is aligned with market demand: the company plans to use funds raised through convertible bonds for coenzymeQ10Expansion and Reconstruction, Annual Production Capacity30000tons of allulose and5000Construction of projects such as ton-scale inositol production. Large-scale capacity expansion requires synchronous or ahead-of-curve growth in future market demand for absorption; if market growth falls short of expectations, it may lead to insufficient capacity utilization and potentially affect investment returns.
and currently, Kingdomway has a high proportion of overseas revenue (2024Annual Overseas Revenue25.66billion yuan, accounting for nearly 80% of total revenue; exchange rate fluctuations and changes in the international trade environment are risk factors that cannot be ignored.
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