Bozhi Yanxin Completes Over RMB 100 Million Series B Financing to Build an Integrated API and Innovative Drug Formulation CRO/CDMO Platform

VCBeat (WeChat ID:(VCBeat) VCBeat has learned that Shanghai Bozhi Yanxin Pharmaceutical Technology Co., Ltd. (hereinafter referred to as “Bozhi Yanxin”) recently completed a Series B financing round exceeding RMB 100 million. The round was led by Changjiang Innovation, with participation from Kaishi Capital and continued follow-on investment from existing shareholder Xingfu Capital. Ying Shuhuan, President of Bozhi Yanxin, stated, “The funds raised in this round will be used to establish an FDA-certified pilot-scale formulation manufacturing base. Combined with Bozhi Yanxin’s existing CRO capabilities, this will accelerate the R&D and industrialization of innovative drugs and novel formulations.”

According to the introduction, this pilot-scale base will achieve FDA-certified cGMP formulation pilot studies and kilogram-scale production of APIs. It can support integrated CRO/CDMO services for innovative drugs, novel formulations, and specialized dosage forms, including BociMed’s unique oral solubilization platform and oral sustained-/controlled-release platform. The CDMO capabilities for BociMed’s complex liquid formulation platform and other advantageous technology platforms will be established in subsequent phases.

BociMed is a high-tech enterprise specializing in pharmaceutical R&D technical services, established in 2012 in Zhangjiang Pharma Valley, Shanghai. Currently, BociMed operates an R&D headquarters in Shanghai, an R&D center in Nanjing, and a clinical subsidiary in Chengdu. With years of accumulated expertise, BociMed has mastered over 200 drug development technologies, with its product portfolio spanning multiple therapeutic areas, including oncology, cardiovascular diseases, immunology, neurology, and psychiatry.

It is reported that BociMed has successively obtained certifications as a “High-Tech Enterprise in Shanghai” and a “Shanghai Patent Work Pilot Enterprise.” From 2017 to 2020, it was consecutively honored for four years as one of the “Top 20 Pharmaceutical R&D Enterprises” by the Federation of Industry and Commerce. In 2019, BociMed was awarded the title of “Shanghai Science and Technology Little Giant Enterprise,” and in 2020, it became the undertaking enterprise for the Ministry of Science and Technology’s Antiviral Small Molecule Drug Platform Project. Also in 2020, BociMed was included in the “2019 China Top 100 Pharmaceutical Industry List” and the “2019 China Top 20 CRO/CDMO Companies Ranking,” both compiled by the Southern Economic Institute.

Leveraging its accumulated innovative technologies, BociMed has set its sights on innovative formulations—pursuing the 505(b)(2) regulatory pathway or developing improved new drugs—and has made forward-looking strategic arrangements.

Modified new drugs are improved versions of already marketed drugs, such as reducing side effects, improving safety, enhancing efficacy and compliance... Since they are improvements on existing drugs, modified new drugs have a certain clinical basis and basically do not require full-scale clinical trials. Therefore, compared to innovative drugs, modified new drugs feature high success rates, high returns, and low risk.

BociMed conducts improved R&D from the perspectives of clinical application and patients, targeting the shortcomings of marketed drugs. It modifies existing active ingredients to reduce or eliminate the defects associated with these pharmaceutical products.

Taking a cardiovascular drug as an example, the pre-optimization dosage was 400 mg. The drug exhibited significant hepatorenal toxicity and pronounced P-glycoprotein (P-gp) efflux, resulting in low oral bioavailability. After optimization using BociMed’s proprietary solubilization technology platform, the dosage was reduced to 50 mg. The optimized drug demonstrated substantially reduced toxicity and was unaffected by gender or food intake, thereby significantly improving patient compliance and medication safety.

BociMed has over 20 improved formulation projects under development, covering both oral solid dosage forms and complex injectables. The company’s confidence in advancing such a large portfolio simultaneously stems from its years of accumulated platform technologies and a compliant, efficient R&D system. For instance, BociMed’s controlled-release platform encompasses various technologies, including gastric-floating sustained release, osmotic pumps, pellet-based drug delivery, sustained-release matrices, and enteric-coated release systems. This platform has yielded complex formulation products such as tofacitinib controlled-release tablets, pregabalin sustained-release tablets, and nifedipine sustained-release tablets. Additionally, its solubilization platform features technologies such as solid dispersion, hot-melt extrusion, self-microemulsifying, and nanocrystals; while its complex injectables platform incorporates techniques like solvent optimization and long-acting insoluble suspensions.

BociMed already holds nearly 80 intellectual property rights, including 33 granted invention patents, 8 utility model patents, and 1 international invention patent.

Leveraging its years of accumulated expertise in drug delivery systems (DDS), BociMed has successfully developed a range of products with varying levels of complexity. Its competitive edge in novel drug delivery systems (NDDS) constitutes BociMed’s core competitiveness.

Technologically, BociMed has established technical barriers through its “API synthesis technology + innovative formulation technology combination.” For instance, by leveraging its expertise in prodrug design and screening, acid/salt polymorph screening, optimization of large-scale synthetic processes, and cutting-edge synthesis technologies, BociMed assists clients in achieving total synthesis of highly complex drugs, process optimization, pre-formulation studies, as well as the research, development, and industrialization of innovative and specialized formulations.

BociMed has established 391 standard operating procedure (SOP) documents, providing comprehensive standardized operations for laboratory safety, hygiene management, R&D site management, confidentiality protocols, and more. Ying Shuhuan stated, “While supporting the research, development, and pilot manufacturing of clinical samples for innovative drugs and novel formulations, BociMed can propose Phase I clinical trial protocols based on in vivo animal evaluation data. Leveraging the eCTD system, we assist clients in rapidly submitting Investigational New Drug (IND) applications in both China and the United States, thereby creating an efficient and compliant integrated IND platform.”

In addition, Chengdu Runze Pharmaceutical, a subsidiary of BociMed, is a clinical CRO that provides services including clinical operations, site management, subject recruitment, clinical biostatistics and data analysis, and clinical protocol consultation. To date, Chengdu Runze has completed over 200 bioequivalence (BE) studies and multiple Phase I–II trials for innovative drugs, demonstrating extensive experience in clinical trials.

With the completion of this round of financing, Bozhi Yanxin’s integrated API and innovative formulation platform will possess a cGMP pilot-scale production base capable of supporting FDA filings. This development will significantly enhance the platform’s competitiveness and further accentuate its advantages in innovative formulations.

Changjiang Securities Innovation Investment (Hubei) Co., Ltd. is a wholly-owned subsidiary of Changjiang Securities, specializing in equity investment. Adhering long-term to the business development strategy of “industry focus and research-driven growth,” Changjiang Innovation has established strategic positions in the biopharmaceuticals, information technology, and new energy sectors. By fully leveraging the industrial background and professional expertise of its investment and research team, the firm assists portfolio companies in their development and accelerates their path toward securitization. To date, Changjiang Innovation has invested in more than ten projects, two of which have completed initial public offerings (IPOs), while several others have secured subsequent rounds of financing.

Xingfu Investment Management Co., Ltd. (hereinafter referred to as “Xingfu Capital”) is a leading new-type private equity investment firm in China. Since its establishment in May 2015, Xingfu Capital has adhered to the philosophy of placing equal emphasis on “capital raising” and “intellectual empowerment,” organically integrating equity investment with innovative investment banking services, and striving to become the best partner and strongest promoter for Chinese entrepreneurs. With the mission of serving as the “capital partner for hidden industry champions,” Xingfu Capital has managed assets exceeding RMB 5 billion and invested in more than 40 leading enterprises in emerging niche sectors. As of June 2020, three companies in Xingfu Capital’s portfolio had completed initial public offerings (IPOs) and listed on stock exchanges, while five companies had achieved exit through mergers and acquisitions. Xingfu Capital has been successively recognized as “Golden Bull Emerging Private Equity Firm,” “China Venture Capital Emerging PE Firm,” “Top 50 Private Equity Firms by Yicai,” “Top 100 Best Private Equity Firms in China by China Venture Capital,” and “Top 50 Best Chinese-funded Private Equity Firms in China by China Venture Capital.”

Kaishi Capital is the core platform under Kaishi Group, specializing in equity investment and mergers and acquisitions (M&A). It has established a highly experienced and professionally excellent international M&A investment team, forged deep strategic partnerships with hundreds of top-tier domestic and foreign financial institutions and large conglomerates, and invested in numerous industry-leading enterprises, earning an outstanding reputation in China’s equity investment sector. Leveraging macroeconomic and industrial research, Kaishi Capital identifies high-potential niche industries and selects the leading companies most likely to stand out within them.