Nuowei Bio Secures Hundreds of Millions in Series B Financing to Accelerate Clinical Development of HPV Nucleic Acid Therapeutics

PharmaCircle has learned that NEWISH, an innovative biotechnology company focused on the research and development of therapeutic nucleic acid drugs, has recently completed a Series B financing round amounting to hundreds of millions of yuan. The round was led by Shanghai Kangcheng Capital Co., Ltd., with participation from several existing and new investors, including STRATEGIC HEALTHCARE HOLDING LIMITED, Shanghai-chi, The Investment Management Ltd., and Qianyuan Fengqiong.

It is understood that this round of financing will be primarily used to advance the clinical development of core products, continuously optimize the STARi technology platform, and develop subsequent innovative pipelines, thereby further accelerating the company’s R&D and industrialization progress in the field of therapeutic nucleic acid drugs.

Persistent HPV infection is a key driver in the development and progression of cervical cancer and various other HPV-related diseases. Unlike prophylactic HPV vaccines, which have established a mature market landscape, therapeutic nucleic acid drugs targeting high-risk HPV in already infected patients are still in the global research and development phase, with no widely approved products currently available.

For patients with persistent HPV16/18 infection and the resulting high-grade squamous intraepithelial lesion (HSIL), current clinical treatment primarily relies on surgical intervention, with limited pharmacological options. Meanwhile, surgical treatment does not directly eliminate the persistently infected HPV virus, leaving patients at risk of recurrence and in need of long-term management. In this context, therapeutic HPV nucleic acid drugs have become one of the important directions in global innovative drug research and development in recent years. NEWISH has laid out a therapeutic product portfolio covering both DNA and mRNA to address this unmet clinical need, exploring the achievement of viral clearance and lesion control by activating specific immune responses.

Newish’s core technologies for nucleic acid therapeutics are derived from its independently owned STARi (Super Targeting Activated Response of Immunization) technology platform. The STARi platform was jointly developed by Newish and Academician Jiang Jiandong of the Chinese Academy of Engineering, focusing on innovative research and development in key areas such as antigen design, delivery optimization, and immune activation.

Publicly available information indicates that the platform employs a targeted enhancement strategy by fusing chemokines with target antigens to promote the uptake and presentation of antigens by key antigen-presenting cells, thereby enhancing specific T-cell immune responses and improving the immunostimulatory capacity of therapeutic nucleic acid drugs.

To date, the company has secured over 40 invention patents related to its technologies and published multiple SCI-indexed papers. In 2024, research findings based on the STARi platform were published in Molecular Cancer, further validating the scientific foundation and development potential of the platform technology.

While advancing the construction of its technology platform, Newish has established a clinical-stage product portfolio covering tumors and HPV-related diseases.

NWRD08 is a therapeutic DNA drug developed for HPV16/18-positive high-grade squamous intraepithelial lesions (HSIL) of the cervix. According to Phase I clinical results disclosed by Newish, NWRD08 has achieved positive progress in terms of safety, immunogenicity, and preliminary efficacy. NWRD08 is also the first HPV therapeutic nucleic acid drug in China to enter clinical development, and the second HPV therapeutic nucleic acid drug globally to enter a randomized, double-blind, placebo-controlled Phase II trial, making it a candidate worthy of anticipation.

Meanwhile, the company’s other HPV therapeutic mRNA nucleic acid drug, NWRD09, has simultaneously advanced to Phase II clinical trials.

In recent years, the biopharmaceutical industry has gradually returned to a development paradigm centered on clinical value and technological innovation. Against this backdrop, innovative enterprises that possess clear clinical needs, proprietary technology platforms, and sustained product development capabilities continue to attract attention from capital markets.

As an investment institution with a long-term focus on innovation in the healthcare sector, Shanghai Kangcheng Capital Co.,Ltd.’s lead investment in this round also reflects the capital market’s continued attention to therapeutic vaccine companies with platform R&D capabilities and clinical translation potential.

From the development trajectory of Newish, its core advantages are reflected not only in the construction of a platform with independent intellectual property rights, but also in advancing multiple products into clinical development and continuously accumulating human study data to validate the platform’s value.

As NWRD08 and NWRD09 enter Phase II clinical trials, Newish is gradually entering a critical stage of clinical value validation.

Therapeutic HPV nucleic acid drugs are considered one of the key areas of exploration in global innovative drug R&D in recent years. Unlike prophylactic vaccines, which work by blocking infection, therapeutic nucleic acid drugs target patients already infected with HPV, aiming to achieve viral clearance and lesion control by activating cellular immune responses. This imposes higher requirements on antigen design, delivery efficiency, and immune activation capability.

From the perspective of the global R&D landscape, various technological approaches—including DNA-based drugs, mRNA-based drugs, viral vector-based drugs, and cell therapies—are currently being actively explored, and no single technology has yet emerged as the unequivocally leading solution. For companies, platform capabilities must ultimately be validated through product development and clinical data.

Following the completion of its hundred-million-yuan Series B financing, Newish is poised to further advance the development of its core pipeline and iterate its platform. The subsequent readout of Phase II clinical data for NWRD08 and NWRD09 will serve as a critical milestone for assessing the progress of therapeutic HPV drug development and the company’s R&D capabilities.

(Note: This article is compiled based on public information and does not constitute any investment advice.)