Biosmelt Pharma Files IPO Prospectus Highlighting Its One-Stop CGT CDO Platform Empowering the 'First Mile' of Innovative Biologics

In recent years, with the successive approvals of domestic CAR-T products—Beinuoda and Yikaida—and the successful global launch of the BCMA CAR-T therapy Carvykti, the field of Cell and Gene Therapy (CGT) has garnered significant attention. The CGT industry is regarded as the golden track for the next decade. Numerous companies have entered the market and strategically positioned themselves in the CGT sector, driving rapid growth in CGT research and development pipelines.

However, in the “race” toward the industrialization of cell and gene therapy (CGT), the high barriers associated with CGT drug CMC process development and GMP manufacturing have become obstacles for pharmaceutical companies advancing CGT commercialization. Innovative biopharmaceutical companies that build in-house production capacity face significant challenges, including arduous personnel training and management, high production costs, complex process workflows, and insufficient experience in risk control. Consequently, these companies are more inclined to outsource drug manufacturing to contract development and manufacturing organizations (CDMOs). The CGT industry’s reliance on CDMOs has made them a focal point in this sector, driving the prosperity of the CGT CDMO industry and facilitating rapid market expansion.

Shanghai Bailian Biopharmaceutical Technology Co., Ltd. (hereinafter referred to as “BIOSMELT PHARMA”) is a company currently focused on providing one-stop CGT CDO (Contract Development Organization) contract services.

BIOSMELT PHARMA was established in 2021 at the Wisdom Plaza of Pujiang Lingang International Science and Technology City, with the aim of empowering startups through innovative processes to drive the “first mile” translation of biopharmaceutical innovations and accelerate the accessibility of cell and gene therapy (CGT) drugs. By providing services such as cell and delivery technology R&D, CMC process development, and GMP pilot-scale production to innovative pharmaceutical companies, the company helps them effectively complete proof-of-concept (POC) clinical validation and investigational new drug (IND) application stages for their pipelines in development, thereby assisting enterprises in advancing high-certainty pipelines into registration clinical trials and commercialization phases.

Prior to founding BIOSMELT PHARMA, founder Wang Haifeng served as R&D Director at a domestic listed company providing lentiviral vector technology services. There, he and his team delivered lentiviral packaging and cell functional validation services based on RNA interference to clients in hospitals and research institutes, accumulating over ten years of experience in the process development and manufacturing of cells and viral vectors. In 2016, Wang Haifeng transitioned from a technical researcher to an entrepreneur, successively establishing Tuling Biology (Yimaike) and Maiying Biology, two digital industrial service platforms dedicated to advancing China’s CGT industry.

Left: Wang Haifeng, Founder and Chairman; Right: Wang Wei, Co-founder and Vice President of Business

Image source: Provided by the interviewee

During this period, Wang Haifeng led his team to start with media channels, tracking the most cutting-edge information in the global field of innovative biologics. By connecting the entire industry chain of innovative biologics through community engagement and offline events, they successfully capitalized on the surge of new technologies in China’s cell and gene therapy (CGT) sector. At that time, numerous biotech companies were entering this track. To date, the domestic CGT market has been gradually maturing, driving a substantial increase in demand for CDMO outsourced services.

Seizing this development opportunity, Wang Haifeng assembled a team and established a company to enter the CGT market, providing one-stop CDO and CMO services to enterprises in the CGT sector to help advance their products from early-stage phases, such as proof of concept, to clinical and commercialization stages.

BIOSMELT PHARMA’s core team members each possess decades of experience in the CGT industry, having held key management positions and successfully completed process development and IND registration filings for novel drug projects involving CAR-T, AAV, oncolytic viruses, exosomes, and other modalities.

Furthermore, other co-founders hail from domestic listed companies and possess CDMO experience serving overseas cell and gene therapy enterprises, bringing rich management expertise and potential clients to BIOSMELT PHARMA.

Notably, the team also possesses the capability to facilitate dual regulatory submissions in both China and the United States, thereby helping clients overcome barriers to international expansion. Currently, the company employs over 70 full-time staff, approximately 20% of whom hold master’s or doctoral degrees. Most mid-to-senior level managers are graduates of prestigious domestic and international universities, including MIT, Peking University, Fudan University, Tsinghua University, and Shanghai Jiao Tong University.

BIOSMELT PHARMA Team Members

Image source: Provided by the interviewee

Due to the significant challenges in manufacturing processes and the complexity of production for cell and gene therapy (CGT) drugs, some candidate drugs struggle to successfully transition from preclinical studies to clinical trials. According to statistics from the American Society of Gene & Cell Therapy (ASGCT), as of Q3 2022, there were 2,031 CGT pipelines under development globally, showing a quarter-on-quarter upward trend, with CGT therapies accounting for approximately 10% of the global pipeline.

Despite the year-on-year increase in the number of preclinical studies and clinical pipelines for cell and gene therapy (CGT), the failure rate in clinical development has also been rising. Pharmaceutical companies face significant challenges in establishing in-house capacity for large-scale Good Manufacturing Practice (GMP) production and advancing R&D progress. According to the Comprehensive Report on Drug Clinical Development jointly released by Informa Pharma Intelligence, BIO, and QLS Advisors, the overall approval rate for CGT pipelines successfully entering Phase I clinical trials from 2011 to 2020 was only 7.9%.

Therefore, CGT CDMO services have become a solution for innovative pharmaceutical companies to overcome challenges such as the complexity of viral vector processes and large-scale GMP manufacturing, capacity shortages, and lengthy production cycles. According to Pharmasalmanac statistics, the outsourcing penetration rate in the CGT industry exceeds 65%, far surpassing the 35% rate for traditional biologics.

In response to the high outsourcing demand in the CGT industry, BIOSMELT PHARMA successively established facilities covering an area of 3,000 m² in 2022.², a laboratory compliant with cGMP and BSL-2 requirements for pathogenic microorganisms, equipped with multiple Grade A production lines suitable for IIT clinical studies, toxicology batches, and IND filings.

The company serves its customers through multiple core innovative technology platforms, including early-stage druggability analysis and validation, development of novel delivery vectors, supercoiled and linearized plasmid manufacturing processes, in vitro transcription (IVT) processes for mRNA, serum-free suspension culture processes for viral vector production, engineered exosome manufacturing processes, immune cell/hematopoietic stem cell manufacturing processes, and a drug quality management system oriented toward regulatory submission.

Leveraging multiple core innovative technology platforms in its laboratories, BIOSMELT PHARMA provides customized services for innovative pharmaceutical companies, including novel delivery vector development (DD), novel cell technology development (CD), process development (PD), analytical method development (AD), quality system development (QD), and cGMP-compliant small-scale and pilot-scale manufacturing. Additionally, the company offers one-stop CMC development and pilot production services, covering regulatory submissions in China and the United States, clinical research consulting, and business development, thereby comprehensively empowering startups to translate biological innovative drug research achievements into practical applications.

It is worth noting that BIOSMELT PHARMA does not merely provide process development and manufacturing services for clinical-stage new drugs, nor process optimization and scaled-up production services for marketed drugs, to cell and gene therapy (CGT) enterprises. Instead, by focusing on innovative early-stage druggability analysis and validation, as well as the development of novel delivery vector technologies, it optimizes tissue specificity and vector structure of candidate drug delivery. This helps clients enhance the efficacy and safety of candidate drugs at the earliest stages of R&D, thereby avoiding the need to “go back” to validate drug efficacy and safety after entering clinical trial phases, ultimately achieving systematic cost reduction and efficiency improvement.

Wang Haifeng stated, “Lead discovery research for CGT drugs is primarily driven by universities, research institutes, and medical institutions within laboratory settings. However, translating laboratory findings into tangible products requires comprehensive re-validation of candidate drugs’ efficacy, safety, and other parameters during the proof-of-concept phase to assess their potential for entering clinical trials, thereby avoiding unnecessary R&D risks and reducing development costs.”

Furthermore, BIOSMELT PHARMA’s technological alignment is closely synchronized with the R&D progress of innovative pharmaceutical companies. Leveraging its digital industrial service platform, the company engages with innovators at the early stages of drug development to conduct in-depth analyses of their candidate drugs and underlying technologies. By identifying critical pain points, BIOSMELT PHARMA delivers customized, one-stop CDO services, encompassing process development, quality research, GMP manufacturing and quality control, as well as stability studies.

This year, BIOSMELT PHARMA has successfully delivered a contract development project for a CGT drug. The project has been accepted by the National Medical Products Administration (NMPA), and the Investigational New Drug (IND) approval is expected to be granted in early 2024.

To date, the company has cultivated nearly 100 potential client leads, with multiple CMC development projects for novel delivery vectors and CGT therapeutics currently undergoing technical discussions and project implementation.

Leveraging its professional CDO service capabilities, BIOSMELT PHARMA is projected to achieve a total revenue exceeding RMB 20 million in 2023. Its affiliated enterprises have successively received honors such as National High-Tech Enterprise, Shanghai Technology-based SME, Shanghai Innovative SME, and Shanghai Specialized, Refined, Differential, and Innovative (SRDI) SME.

Wang Haifeng stated, “BIOSMELT PHARMA’s development path follows a three-step strategy. The first step is to build client-serving capabilities primarily through CDO services, thereby accumulating technological and market advantages. The second step involves expanding the service scope by sequentially laying out CTDO and CMO segments on the foundation of CDO services. In the third step, the company will ultimately become an innovative enterprise offering comprehensive CTDMO solutions, providing customers with professional, stable, one-stop CTDMO services over the long term.”

Currently, BIOSMELT PHARMA is in Phase I. In 2021, BIOSMELT PHARMA completed an angel financing round of tens of millions of yuan to advance the construction of its GMP laboratory and team building.

The company is currently planning a new round of financing to further advance the construction of facilities required for CMO development, marking its entry into the second phase. In the future, BIOSMELT PHARMA will continue to innovate its core technologies and expand its CTDO business segment, addressing unmet market needs in the field of novel drug characterization analysis and testing.

Looking to the future, Wang Haifeng stated, “The CGT field still faces numerous technical challenges. The critical bottleneck lies in rapidly validating the feasibility of partial or full substitution with domestically produced alternatives, and in generating head-to-head comparative data against mature products through process optimization, thereby providing reverse guidance to manufacturers for product iteration. Therefore, BIOSMELT PHARMA focuses on early-stage CMC development, aiming to influence more innovative biotech companies by helping them advance their drug candidates into human clinical trials, thus enhancing their future commercial competitiveness and ability to secure financing in the capital markets.”

Based on this, BIOSMELT PHARMA has embarked on CDO services, with the core objectives of expanding new technologies, processes, and products, while continuously enhancing its team’s CMC development capabilities for a diverse range of drug candidates.

Furthermore, the company continuously innovates its technical processes to enhance its service capabilities in testing, analysis, and validation—namely, “Testing”—assisting clients in conducting characterization and impurity analyses of drugs under development. This helps improve drug quality, increase the success rate of clinical trials for candidate drugs, and enhance their commercial accessibility.

According to Frost & Sullivan analysis, the global CGT CDMO market size grew from $770 million in 2016 to $1.72 billion in 2020, representing a compound annual growth rate (CAGR) of 22.4%, and is projected to reach $7.86 billion by 2025. Meanwhile, China’s CGT CDMO market size is expected to grow from RMB 870 million in 2018 to RMB 19.74 billion in 2027.

In the multi-billion-dollar CGT CDMO sector, BIOSMELT PHARMA will continue to build a patent moat, leverage innovative technologies to improve the success rate of process development, and accelerate clinical translation of drugs, ultimately helping pharmaceutical companies reduce drug production costs and provide patients with more treatment options.