Exclusive Interview with Dr. Jiang Lin, Founder of BIOQINGLAM: Partnering with Innovative Biopharma to Unlock the True Value of Microneedle Drug Delivery

Shenzhen Qinglan Biotechnology Co., Ltd. (hereinafter referred to as “Qinglan Biotech” or “Qinglan”) has been committed to advancing the industrialization of microneedle technology since its inception. By being among the first to resolve key challenges in the mass production of microneedle products, the company emerged as a rising star in China’s medical aesthetics microneedle sector, attracting significant attention from the capital market. However, despite its considerable success in the field of medical aesthetics microneedles,Dr. Jiang Lin, Founder and CEO of Qinglan Bio, has always maintained that microneedles, as a transdermal drug delivery technology, can truly demonstrate their value only when applied to drug development.

In early 2021, Qinglan Bio established a strategic partnership with a domestic biotech company specializing in DNA vaccine research and development. As collaboration between the two parties deepened, and as the company successively entered into partnerships with numerous other pharmaceutical enterprises,Qinglan has completed its strategic transformation from an R&D enterprise focused on aesthetic micro-needles to one dedicated to pharmaceutical micro-needle development. The company is now concentrating on the R&D and industrialization of dissolving microneedle transdermal drug delivery technology, committed to providing CRO/CDMO services to a broad range of pharmaceutical companies.

Currently, Qinglan Biotech has successively initiated in-depth collaborations with multiple domestic pharmaceutical companies on microneedle drug development and has established a dedicated microneedle R&D and manufacturing facility. This facility fully meets the stringent requirements for reproducibility, stability, automation, and cleanliness in the production of sterile microneedle-based pharmaceutical products, positioning the company at the forefront of industry technological advancements.

Building on its achievements in microneedle-based drug development, Qinglan has garnered significant interest from strategic partners and premium investors, completing two rounds of financing within two years—though discreetly. This prompts our curiosity: What specific work has Qinglan undertaken in microneedle drug R&D over the past two years, and what substantive progress has it made? Given the favorable trajectory of medical aesthetic microneedle products, why has the company chosen a “high-risk strategy,” redirecting the majority of its resources toward the more challenging realm of microneedle drug development?

Therefore, VCBeat conducted an in-depth dialogue with Dr. Jiang Lin:

(For the convenience of readers, VCBeat has edited parts of this dialogue without altering the original meaning:)

VCBeat: Given the favorable development of microneedle products in the medical aesthetics sector, why has the company shifted its business focus to the research and development of microneedle-based pharmaceuticals?

Dr. Jiang Lin:Following its establishment in July 2020, Qinglan Biotech had built a microneedle patch production line with a single-line monthly capacity of over 4.8 million patches by the end of that year. The company initiated collaborations with numerous clients in the medical aesthetics industry and even established a dedicated sales team for medical aesthetics products. In early 2021, we engaged with our first biopharmaceutical client, an innovative drug company specializing in DNA vaccines. Research and development of DNA vaccines is extremely challenging; their delivery technology poses greater difficulties than mRNA technology in certain aspects. Moreover, there are few companies with mature technologies available to jointly address and accumulate solutions to these technical challenges.We initiated our collaboration with the client in the first lunar month of 2021 and achieved favorable initial delivery results by mid-April. This marked Qinglan Biologics’ inaugural endeavor in the field of microneedle drug development, a milestone that has profoundly influenced the company’s strategic direction.

Faced with the experimental results, the client recognized the immense application potential of microneedle technology and decided to invest in Qinglan Biotech, completing due diligence and closing the transaction within three months.The ultimate goal behind the establishment of all microneedle companies, both domestically and internationally, is to venture into drug development; the application of microneedles in medical aesthetics serves merely as a transitional strategy while the technology is still maturing. Qinglan Biotechnology achieved remarkable results with its initial efforts. Starting in the second half of 2021, we realigned the company’s technological and operational focus toward the application of microneedle technology in drug development. Accordingly, the company has comprehensively shifted its team structure, instrumentation, and regulatory systems toward drug R&D.

VCBeat: From the beginning of last year to now, we have heard that Qinglan has made many substantial progress in the research and development of microneedle drugs. Can you share it with us briefly?

Dr. Jiang Lin:It has been nearly two years since the beginning of last year. We spent these two years serving our first client. Developing innovative drugs is extremely challenging, and doing so with microneedles is even more difficult. The pharmaceutical research, as defined by regulatory requirements, must be conducted using a microneedle-based delivery system rather than conventional dosage forms.How Can Microneedle Technology Meet the Requirements of Pharmaceutical Research? This is a highly complex systems engineering endeavor involving processes, equipment, materials, formulations, regulations, and regulatory review practices. It is extremely difficult for any biotech company to independently accomplish this series of cross-disciplinary innovations without collaboration with pharmaceutical machinery manufacturers. This explains why, despite the microneedle concept being proposed decades ago, no commercial approval has yet been granted for dissolving microneedles.

Over the past year, we collaborated with clients to confirm immunogenicity and optimize patch application duration, facilitating in vivo transfection of DNA vaccines without electroporation and reducing dosage requirements. Since January this year, Qinglan’s proprietary workshop has completed upgrades to a Grade B+A cleanroom environment, achieving the first mass production of sterile microneedle vaccines in China. Currently, Qinglan has fully aligned all aspects of pharmaceutical research for microneedle drugs within regulatory frameworks. We have independently developed all equipment for microneedle manufacturing processes, holding complete intellectual property rights. This year, Qinglan filed 15 patent applications, over 80% of which were invention patents. We do not merely conduct laboratory-based microneedle R&D for clients; all our samples are produced at Qinglan’s pharmaceutical R&D manufacturing facility. The process parameters established through sample preparation using mass-production facilities will be directly applied to drug registration filings.

In addition to vaccines, Qinglan plans to register all future microneedle drug products as sterile injectables. We currently offer clients a full suite of CRO services for preclinical microneedle studies and are capable of providing R&D-grade microneedle samples for all stages up to and including Phase II clinical trials. Our Phase III clinical and commercial manufacturing facilities are scheduled to be completed in Shenzhen in 2023. All microneedle process equipment has been independently developed by Qinglan, with the 3Q documentation and validation protocols prepared entirely by our internal team. Achieving this required substantial engineering innovation, and I believe that professionals genuinely experienced in pharmaceutical development will appreciate the significant challenges and workload involved. Our current quality system supports regulatory submissions in compliance with CP, EP, and USP standards. The above summarizes our achievements in microneedle industrialization over the past two years.

VCBeat: This is indeed exciting progress in the field of microneedles. Given that dissolving microneedles represent a novel dosage form and a platform technology, apart from DNA vaccines, what other categories of drugs has Qinglan’s dissolving microneedle technology been successfully applied to? Could you provide more details on these research efforts?

Dr. Jiang Lin:Since mid-April 2021, when Qinglan participated in the VCBeat Future Healthcare 100 Forum, we have maintained a media blackout for 20 months. During this period, we successfully closed two rounds of financing without any public announcements. While microneedle technology for drug delivery is inherently newsworthy, its application in pharmaceutical R&D is a matter of grave seriousness, standing in stark contrast to the operational style typical of the medical aesthetics industry. Over these past 20 months, we have proceeded with utmost caution, as we are challenging the status quo with a disruptive drug delivery modality. We have consistently approached our R&D and experimental work with profound humility.

Although we have been dedicated to research and industrialization behind closed doors, news of our collaborations with clients has still circulated within the industry. Naturally, many pharmaceutical companies with an urgent need for microneedle technology in their drug development pipelines have proactively reached out to us. From August 2021 to the present, despite Qinglan Biotech having no business development (BD) personnel, more than 25 pharmaceutical companies of various types have approached us seeking collaboration on microneedle technology, demonstrating the broad demand for this technology. These companies include those developing innovative drugs, generics, biologics, and chemical drugs, and most are either publicly listed or have already filed for an initial public offering (IPO).

These drug categories span a very wide range; even though microneedle technology is a platform technology, we do not have the courage to take on so many drug types at once.Based on the types of drugs identified and our technological expertise, while also considering business factors, we have selected two antibody drugs and one peptide drug to explore the feasibility of developing them into microneedle formulations, as an extension beyond our DNA vaccine portfolio.These drugs are primarily innovative medicines, or active pharmaceutical ingredients (APIs) that have been commercially launched for less than one year.

Some may ask: Microneedle technology is relatively novel and not yet fully mature, while the development of innovative drugs is inherently challenging. Doesn’t combining these two cutting-edge technologies make the task even more difficult? Why choose such a demanding path as the direction for technological breakthrough? We will not elaborate extensively here; instead, we present our conclusion: This is precisely the approach most likely to lead microneedle technology to successful breakthroughs. Interested readers are welcome to engage in further in-depth discussions with us. Time will tell.

With the CMC studies for our first project fully integrated, we initiated research on three new drug projects in late September this year.Currently, for peptide drug microneedle patches, we have achieved highly favorable pharmacodynamic profiles in collaboration with our clients. A key feature of Qinglan’s microneedle technology is its excellent data consistency. The pharmacodynamic profile of our peptide microneedles shows no statistically significant difference compared to injectable formulations, which is the aspect most appreciated by our clients.Research institutions both in China and abroad engaged in microneedle studies are well aware that the primary challenge of dissolving microneedle technology lies in ensuring data consistency.It is easy to achieve therapeutic efficacy with a few patches; the challenge lies in ensuring the consistency of the pharmacodynamic or pharmacokinetic profiles across all 100 microneedle patches. This consistency is the key factor for customers to accept it as a reliable drug delivery method. Only with good consistency in microneedle drug development data can regulatory submission materials be compiled, and only then can the project advance vertically. Furthermore, our antibody drug has demonstrated PK profiles very similar to those of injectables, greatly impressing customers with the favorable pharmacokinetic results obtained from our initial formulation samples.

Prior to Qinglan Bio’s completion of its first round of financing, we also engaged with numerous investment institutions. Their questions predominantly focused on the processes and manufacturing techniques of microneedles, attempting to require microneedle companies to demonstrate the rationality of their proposed manufacturing processes in order to assess whether their microneedle technology could be successfully commercialized at scale. This approach is inadvisable. To my knowledge, there are significant disparities among the technologies employed by several domestic microneedle companies in China, and consensus has yet to be reached on even the most fundamental aspects. We recommend thatMicroneedle technology should be evaluated based on outcomes rather than processes. Many procedural techniques are merely conceptualized by microneedle companies themselves; they may lack stability and reliability, and may not withstand the scrutiny of pharmaceutical regulatory review.Focusing on the process while ultimately aiming to demonstrate the certainty of outcomes is a typical tactic employed by institutions when pitching PPT-based financing projects. Why not demand tangible results from microneedle companies? When results are visible to the naked eye, further justification becomes unnecessary. A technology that has been proposed for decades still fails to achieve industrialization; if not now, then when? This is akin to embarking on a journey to the West to retrieve Buddhist scriptures: you rally companions in Chang’an before even departing, claiming you know how to defeat the demons you might encounter along the way. In contrast, if you could share practical experiences—detailing the specific demons encountered in the Western Regions, Afghanistan, and India, explaining how they were overcome, and vividly describing the local customs and conditions—you would be far more convincing when inviting others to join you on another journey. We have felt this distinction acutely in our communications with pharmaceutical companies.

The pharmaceutical companies we collaborate with fall into two categories. The majority, who have heard about our research findings within the industry, approach Qinglan directly; this group is expected to yield a higher conversion rate in the future. The other category consists of those who conduct business development outreach to all our competitors before focusing their efforts on engaging with Qinglan. Our current client base comprises organizations with highly innovative teams and extensive experience in the R&D and regulatory registration of novel drugs. Although these clients may not be familiar with microneedle technology, they understand the underlying logic and processes of drug development, which share common foundational principles for pharmaceutics studies as required by regulations. When we communicate entirely in the language of pharmaceutical development, it becomes easy to achieve technical resonance with our clients.

Qinglan Bio is currently the only company in China specializing in dissolving microneedle technology that sustains its operations through drug R&D. With a rigorous and diligent approach, we provide CRO and CDMO services to pharmaceutical companies. Our initial business focus has been on clients developing innovative drugs, as dissolving microneedle technology offers transformative clinical advantages. We have now mastered microneedle delivery technologies for gene therapies, antibody drugs, and peptide drugs, which highlights the vast application potential of microneedle technology.

VCBeat: What clinical advantages do you believe dissolving microneedle technology offers? Which of these are the most critical?

Dr. Jiang Lin:This is a significant issue. Over the past few years, when engaging with professionals, we have frequently encountered very basic yet difficult-to-answer questions, such as: What materials are your microneedles made of? Where on the body are your microneedle patches applied? What is the height of your microneedles? Many of these questions leave us both amused and exasperated. However, such situations are entirely understandable, as there is currently a severe lack of general knowledge about dissolving microneedles in both academic literature and publicly available online information. Dissolving microneedles represent a dosage form technology, a technical concept comparable to tablets, capsules, and injectables. If no specific active pharmaceutical ingredient (API) is designated, it would be impossible to answer questions such as: What materials are the tablets made of? What size are the tablets intended to be? How many tablets should be taken at one dose?Since it is a formulation, the active pharmaceutical ingredient (API) must be specified first before determining the excipients. Different APIs undoubtedly require different excipient formulations. The same principle applies to microneedles; there is a distinct field of microneedle pharmaceutics, although it has not yet been incorporated into standard textbooks. I have not yet selected an API, so what is the purpose of specifying the microneedle height at this stage? It is akin to insisting on defining the tablet dimensions before even deciding what type of tablet to develop. Microneedle height is merely one parameter that needs to be optimized within microneedle pharmaceutics, and such optimization should be based on the delivery requirements of the API.These are all minor episodes we encountered during our microneedle research.

The question of the clinical advantages of dissolving microneedles is not one that can be answered with a broad generalization. The more drugs we have studied in parallel, the more cautious we become in addressing such questions. We do not dare to draw universal conclusions for drugs we have not yet investigated; instead, we can only discuss the clinical advantages of dissolving microneedles with respect to the specific drug types we have studied. This approach reflects a rigorous scientific attitude.

DNA vaccines and mRNA vaccines ultimately exert their effects through the same mechanism: mRNA is translated into proteins that serve as antigens, representing different paths to the same destination. DNA vaccines must cross the cell membrane and enter the nucleus, where they are transcribed into mRNA; this mRNA then returns to the cytoplasmic organelles for translation into protein antigens. Thus, DNA vaccines require a longer intracellular pathway to achieve protein translation. Due to the greater losses associated with this extended pathway, DNA vaccines typically require higher doses than mRNA vaccines to achieve equivalent antibody titers. Many DNA vaccines do not utilize lipid nanoparticle (LNP) encapsulation; instead, physical electroporation (EP) devices are employed for delivery after injection. As preventive vaccines, however, this approach results in poor patient compliance.

Qinglan Biologics’ microneedle technology enables needle-free and electroporation-free administration, allowing vaccines to be delivered via a simple patch application similar to a bandage, thereby significantly improving patient compliance. Recent data indicate that microneedles can also reduce the required antigen dosage; we have co-authored a scientific paper with our clients detailing these findings, which is scheduled for publication in the near future. The clinical advantages of microneedle-based vaccines are substantial and poised to revolutionize the vaccine landscape. In particular, microneedle technology complements DNA vaccine platforms by maximizing their benefits while mitigating limitations, notably through dose reduction and a marked improvement in patient compliance.

Qinglan Bio’s microneedle technology enables injection-free and electroporation-free vaccine administration, allowing vaccines to be delivered via a simple patch application akin to a band-aid, thereby significantly improving patient compliance. Recent data indicate that microneedles can also reduce the required antigen dosage; we have co-authored a scientific paper with our clients detailing these findings, which is scheduled for publication in the near future. The clinical advantages of microneedle-based vaccines are substantial and poised to revolutionize the vaccine landscape. In particular, microneedle technology complements DNA vaccine platforms by maximizing their strengths while mitigating limitations, thus leveraging their inherent advantages, reducing dosage requirements, and markedly enhancing compliance.

Currently, other pharmaceutical clients are approaching us for collaboration on microneedle technology, with clinical advantages as the primary consideration. The indications approved for currently marketed anti-tumor antibody drugs are almost always last-resort options for cancer patients. With the limited extension of life these therapies provide, patients hope to spend their remaining time with quality at home, rather than passing away in a hospital. The anti-tumor antibody sector is experiencing intense competition, with numerous products already commercialized and many more in development; therefore, differentiated development has become a key direction for antibody drug innovation. In recent years, a significant technological trend has been the shift from intravenous to subcutaneous administration of anti-tumor antibodies, aiming to reduce hospitalizations and improve patients’ quality of life. Intradermal delivery via microneedles offers an even more optimized administration route than subcutaneous injection, potentially enabling patients to self-administer treatment at home. Due to the scarcity of microneedle technology, it has emerged as an important option for the differentiated development of anti-tumor antibody drugs.

However, the application of dissolving microneedle technology for the delivery of antibody drugs presents significant technical challenges. Antibody drugs typically require doses in the range of hundreds of milligrams per injection, whereas recent review literature on microneedles has firmly established that dissolving microneedle technology is severely limited by its inability to accommodate high-dose payloads.Qinglan Biotech has leveraged patented technology to transcend the literature-defined boundaries of dissolving microneedle technology, successfully developing a microneedle patch for high-dose antibody drugs.If the absolute dosage of antibody drugs in microneedles is not addressed, it will be impossible to secure R&D orders from antibody drug companies—a result-oriented reality. Therefore, the successful commercialization of dissolvable microneedles requires not only solving industrialization and engineering challenges but also addressing academic issues that remain unresolved in scientific literature. You must advance like a bulldozer to find fulfillment in the vast field of microneedle technology; otherwise, R&D personnel will encounter nothing but endless frustration. Currently, the three antibody drug companies negotiating collaborations with Qinglan are all pharmaceutical firms that have successfully completed their IPOs.

Peptide DrugsInjectable formulations are generally used, requiring frequent administration. Currently, there is a trend toward developing complex injectable peptide drugs, particularly injectable microspheres, with the aim of extending the half-life of peptide drugs, reducing dosing frequency, and improving patient compliance. Dissolving microneedles for peptide drug delivery offer a band-aid-like experience that administers medication without injections or oral intake, resulting in the greatest improvement in compliance—even higher than that of once-monthly injectable microspheres. In addition, to extend the half-life of peptide drugs in the body, synthetic modifications are often made to the peptides, or specific amino acid sites are altered. Such synthetic modifications inevitably increase the cost of peptide drugs, thereby raising the economic burden on patients. Due to the high compliance associated with dissolving microneedle patches, daily dosing is acceptable. The absence of syringes significantly reduces medication costs for patients, which will also become a major clinical advantage.

We are still experimenting with other types of drugs. We believe that formulating different drugs into microneedle patches always offers more advantages than disadvantages. This is a fascinating disruptive technology, and we are deeply engrossed in it.

VCBeat: Have these projects encountered any significant challenges during their implementation?

Dr. Jiang Lin:The difficulty is immense. It is akin to producing injectables a century ago, when the entire suite of process equipment—including washing, drying, filling, sealing, and visual inspection—was unavailable. How, then, could injectables be manufactured? Regulatory requirements were stringent; furthermore, there were no established specifications or methodologies for testing finished and semi-finished products.All process equipment must be developed in-house, and all R&D methodologies and metrics must be determined independently, with no reference materials available.Dissolvable microneedle technology requires a company to handle every step of the process independently, without relying on any external parties. Only by achieving this level of self-sufficiency can one succeed. Therefore, Qinglan Bio’s microneedle technology faces no “chokehold” risks; we rely neither on foreign companies nor are we constrained by domestic enterprises at any stage of our operations. Consequently, developing microneedle technology is a profoundly solitary endeavor that demands the ability to endure isolation. When challenges arise, seeking help from others proves futile, and breakthroughs leave no one with whom to share the achievement. We often explain to clients how we resolved critical technical issues, yet they remain indifferent to the process, caring only about the results.

Merely stating this may not fully convey the technical challenges encountered in the research and development of microneedle technology. By examining a specific aspect in detail, we can illustrate the overall complexity of microneedle development. As previously mentioned, we are conducting the R&D and regulatory registration of dissolvable microneedles in accordance with the standards for sterile injectables. During our Chemistry, Manufacturing, and Controls (CMC) studies, we encountered the challenge of how to perform 100% inspection on the finished microneedle products.For injectables, well-established methods for 100% inspection are available, typically performed by automated visual inspection machines. The processes and equipment for visual inspection are mature; Chinese manufacturers such as Truking and Tofflon have made significant advancements in this area. Therefore, when conducting CMC work for injectables, there is no need to develop custom visual inspection equipment. However, what should be done when microneedle development reaches this stage? How can 100% inspection be implemented after microneedles are manufactured? Would submitting a manual 100% inspection protocol face regulatory challenges? In the early days of injectable production, manual 100% inspection was acceptable. However, with technological advancements in the industry, manual visual inspection for injectables is no longer recognized by current regulations.The technical specifications of microneedles differ fundamentally from those of liquid formulations in ampoules or vials, and the classification of defects is also distinct. This necessitates adopting the aforementioned approach: delving into the underlying logic of visual inspection to enable further progress in the development process.We believe that, regardless of the product, the underlying logic for visual inspection is to first capture clear images of the product, then define inspection criteria based on its specific characteristics, and finally establish the acceptable ranges for these criteria through R&D. Only this approach is acceptable to the Center for Drug Evaluation (CDE). The process and equipment for the visual inspection machine used in Qinglan Biotech’s self-developed microneedle patches have been patented.The above examples merely illustrate the challenges in developing microneedle technology; those with experience in pharmaceutical development understand just how difficult it truly is.

VCBeat: What is the current collaboration model between Qinglan and pharmaceutical company clients? During the course of working with clients, what moments have left a deep impression on you?

Dr. Jiang Lin:Upon engagement with clients, we prioritize detailed discussions regarding the specific active pharmaceutical ingredient (API) intended for development, as understanding its physicochemical properties is critical to the formulation of microneedle preparations.We have now accumulated a certain level of experience in the development of microneedle formulations. Essentially, we can determine during the initial online meeting with a client whether their API is suitable for development into a microneedle dosage form at the current stage.Of course, during this process, clients also raise many questions about microneedle technology. We respond to these inquiries politely and patiently. However, whether or not we answer these questions has no impact whatsoever on our fabrication of microneedles. We believe that such responses merely address the clients’ curiosity and are far from sufficient for the actual production of microneedles. Most of the questions clients ask at this stage are quite basic.

Upon confirmation that this API is suitable for development into a microneedle formulation, we can ensure the initiation of animal studies at the client’s site within one month.Within this month, we will coordinate with the client to finalize the establishment of animal models, the design of animal study protocols, and the determination of the initial microneedle dosage.When we conducted animal studies at a client’s site one month later, the client was often still taken aback, feeling that progress had been unusually rapid and that a seemingly far-fetched technology was being put into practice. Of course, regardless of how quickly we moved, we inevitably encountered skepticism. At one client site, an experienced animal study engineer had never previously performed microneedle-based animal experiments. After learning about the principle of microneedles, the engineer found it hard to believe. We provided training on the patch application technique, but the engineer showed little enthusiasm, was unwilling to learn the procedure, and essentially remained a passive observer. However, upon seeing the next day that the pharmacodynamic data from the microneedle group showed no statistically significant difference compared with the injection control group, the engineer was astonished and immediately underwent a 180-degree change in attitude, becoming highly engaged in the remaining microneedle experiments.

Since our clients are primarily innovators in novel and biologic drugs, and the clients we initially selected are well-known companies in their respective sectors with strong technical capabilities, these innovative pharmaceutical enterprises have established comprehensive confidentiality systems. During the process of collaborating with us to develop microneedle formulations, clients often need to share analytical methods for their active pharmaceutical ingredients (APIs), based on which we develop analytical methods for the microneedle formulations. Although clients have signed non-disclosure agreements with us, they are often hesitant when sharing such information in the early stages; while they agree to provide the technical data, they are not entirely willing to do so in practice. We fully understand this mindset: before being certain that our microneedle technology will succeed, they are reluctant to risk leakage of their hard-earned R&D data for innovative drugs. HoweverOnce the pharmacodynamic or pharmacokinetic data for the microneedles became available, and the client observed favorable results with good data consistency, they became highly proactive and cooperative in sharing technical documentation.We once conducted “blind development” for clients, where we only knew the API type and received no written physicochemical data from them. In such cases, we had to formulate microneedle preparations solely based on our prior experience. By the way, all microneedle formulations at Qinglan are now personally prepared by me. Promoting microneedle technology is highly challenging; through extensive communication, we have gained deep insights into the mindset of pharmaceutical companies. Business development for microneedle technology does not require specialized BD professionals; it is entirely technology-driven, or even more precisely, data-results-driven, relying on compelling data to secure customer orders.

Our current business model with clients encompasses both CRO and CDMO services. Some clients initially sign a preclinical pharmaceutical CRO contract, while others directly execute comprehensive CDMO agreements covering the entire spectrum from IND filing to commercialization. Qinglan does not intend to pursue independent regulatory registration for microneedle drugs. Instead, our objective is to rapidly promote dissolving microneedle technology. Therefore, we have defined our business model as serving other pharmaceutical companies by providing full-spectrum solutions for microneedle technology.

VCBeat: What are Qinglan's next steps for development?

Dr. Jiang Lin:There is a wide variety of pharmaceuticals. We are currently focusing primarily on the field of biologics, where research is highly active and the diversity of products is substantial. For instance, in addition to the three categories of biologic microneedle R&D projects already underway, we are also in negotiations forAAV VectorsAPI, also hasGene TherapyFor our clients, there is a wide range of biologics that can be delivered via microneedles. New customers contact us directly, and I always ask how they discovered Qinglan Bio. The most common response is referrals from peers in the pharmaceutical industry. We are deeply grateful for the industry’s recognition of Qinglan Bio. At the same time, we feel significant pressure. It is rare for China to achieve leadership in drug technologies across various therapeutic areas. Our current focus is on serving domestic innovative pharmaceutical companies well, with the next step being to gain recognition from well-known state-owned pharmaceutical enterprises—a considerable challenge.