HighTide Therapeutics Secures $107 Million in Series C/C+ Financing to Advance Global Clinical Development, Commercialization, and Business Expansion

January 5, 2023, Shenzhen, China and Rockville, Maryland, USA—HighTide Therapeutics Inc. announced the completion of a $107 million Series C/C+ financing round. The round was led by China Development Bank Capital and the Guangdong Traditional Chinese Medicine Health Equity Investment Fund Partnership Enterprise (Limited Partnership), which is managed by Guangdong State-owned Assets Supervision and Administration Commission-affiliated entities. Guangzhou YUEXIU Industrial Investment Fund Management Co., Ltd., capital under Yufeng Shengtai Fund with assets exceeding RMB 10 billion, and related enterprises also participated in the investment.

The funds raised in this round will be used to advance the late-stage global clinical development, commercialization, and business development of multiple candidates in HighTide’s pipeline. The company’s core products are multi-functional, global first-in-class innovative drugs independently designed and developed based on natural products, integrating real-world data from traditional Chinese medicine with modern drug R&D concepts, and holding global intellectual property rights. Currently, the company is conducting multiple clinical studies internationally, which are expected to provide novel comprehensive treatment solutions for patients with metabolic and digestive system diseases worldwide.

The Company’s R&D is progressing smoothly, with multiple clinical development pipelines being actively advanced, including:

● Phase II clinical study for type 2 diabetes mellitus (T2DM) is nearing completion;

● Initiated a Phase IIb clinical study for non-alcoholic steatohepatitis (NASH);

● Based on positive results from the Phase II clinical study of primary sclerosing cholangitis (PSC), a successful End-of-Phase 2 (EOP2) meeting was held with the U.S. Food and Drug Administration (FDA).

“Following the completion of our $60 million Series B+ financing round in late 2020, we are delighted to have secured an additional $107 million in investment from renowned institutions in our Series C/C+ round. We extend our sincere gratitude to all new and existing investors for their trust and support,” said Dr. Liu Liping, Founder and CEO of HighTide. “Our investor base comprises both strategic industry investors and financial investors, whose combined strengths will bolster our global development, commercialization, and business development efforts. The HighTide team remains committed to accelerating the delivery of safe and effective first-in-class innovative medicines to patients worldwide, with the aim of establishing HighTide as an internationally competitive innovative pharmaceutical company.”

Mr. Liu Jiangbo, Chairman of the Guangdong Traditional Chinese Medicine Health Equity Investment Fund Partnership Enterprise (Limited Partnership)Statement: On May 12, 2021, during an inspection tour of Nanyang, national leaders emphasized that “we should promote the development of Traditional Chinese Medicine (TCM), focus on interpreting TCM principles through modern science, and pursue a path of integrated traditional Chinese and Western medicine.” The 20th National Congress of the Communist Party of China further reaffirmed the policy of “promoting the inheritance and development of TCM.” As the Guangdong Traditional Chinese Medicine Health Equity Investment Fund Partnership Enterprise (Limited Partnership) assumes the responsibility of implementing national policies and fostering industrial growth, its investment objective, established at inception, is to serve national strategies. Guided by the core philosophy of inheriting, innovating, and developing TCM, the fund adheres to equal emphasis on both traditional Chinese and Western medicine, strengthens layout in key areas or weak links, accelerates the modernization and industrialization of TCM, promotes high-quality development of the TCM sector and industry, and advances the global outreach of TCM.

HighTide is an investment target that aligns closely with the original intent of the fund’s establishment. Particularly in the inheritance and innovation of Traditional Chinese Medicine (TCM), as well as in promoting the modernization and internationalization of TCM, HighTide has pioneered a new path: upholding the principle of “preserving the essence while innovating with integrity,” it has emerged as a leading enterprise going global. This year marks the 50th anniversary of the discovery of artemisinin. Building on traditional natural medicines with clearly defined pharmacological activities, HighTide integrates modern drug design and development concepts to create original innovative drugs. It has secured patent protection in major pharmaceutical markets including China, the United States, Europe, and Japan, adheres to international drug development standards, and focuses on indications lacking effective solutions worldwide. Under the national strategic initiative vigorously promoting the “modernization and internationalization of TCM,” HTD1801, one of HighTide’s core products in development, is poised to become another flagship example of TCM’s successful global expansion following artemisinin. This achievement will highlight the clinical value of traditional Chinese medicine and its significant contributions to global healthcare, while realizing the substantial commercial value of TCM’s modernized innovations in the international market.

Mr. Lu Rong, Managing Partner and President of YUEXIU Industrial Fund ManagementIt is widely recognized that building a Healthy China is inseparable from Traditional Chinese Medicine (TCM), and the development of TCM has been elevated to a national strategy. Rooted in traditional medicine, HighTide leverages extensive existing data on the safety and efficacy of natural products to creatively match and integrate them, thereby developing a series of new drug candidates with multi-faceted potential. These projects have yielded promising clinical results and data in global clinical trials conducted in the United States, Canada, Australia, and other regions. Notably, its core developed product, HTD1801, is an innovative molecular entity recognized by the U.S. FDA. It has met efficacy endpoints in multiple global clinical studies and demonstrated a favorable safety profile, highlighting highly predictable prospects for successful drug development. Based on in-depth research in the field of innovative drugs, YUEXIU Industrial Investment Fund highly recognizes HighTide’s R&D achievements and is optimistic about its R&D strategy, competitive advantages, and commercialization potential. The fund will firmly support HighTide in continuously developing innovative drugs with international competitiveness, contributing to the accelerated modernization and industrialization of TCM.

Mr. Ma Lixiong, Chairman of Yufeng Shengtai Investment Management Co., Ltd.Highlight: HighTide possesses the qualities to become a global pharmaceutical and biotech giant. Its products are unique, featuring globally innovative molecules that have received recognition from the U.S. FDA. The company operates in a niche with few competitors; its core product, HTD1801, targets unmet clinical needs in metabolic and digestive diseases and demonstrates high druggability. HighTide’s operations are internationalized, with multi-regional clinical trials (MRCT) underway in the United States, Canada, China, and Australia, supported by a global executive leadership team and worldwide sales capabilities. Ample funding and strong refinancing capacity based on its drug pipeline serve as key drivers for HighTide’s substantial growth. Several indications addressed by its portfolio truly meet unmet clinical needs, benefiting a large patient population. As these treatments are intended for long-term chronic disease management, successful commercialization is expected to generate stable, long-term cash flow for the company. We firmly believe in HighTide’s long-term commitment and significant growth potential in this field. We are confident that HighTide’s products will benefit patients worldwide, positioning the company as a leader in the biopharmaceutical sector and delivering sustainable, robust returns for investors.

HighTide is a globally integrated, clinical-stage biotechnology company dedicated to addressing significant unmet clinical needs in areas such as metabolic diseases and digestive system disorders. Guided by an experienced international executive team and a world-class Scientific Advisory Board, the company is committed to source innovation, aiming to deliver comprehensive clinical benefits and overall health improvements for patients by developing “First-in-Class” multi-target novel drugs.

Leveraging its independent intellectual property rights, the Company has established a robust product pipeline and is advancing multiple mid- to late-stage clinical trials globally for indications including type 2 diabetes mellitus (T2DM), non-alcoholic steatohepatitis (NASH), severe hypertriglyceridemia (SHTG), and primary sclerosing cholangitis (PSC). As a first-in-class multi-target new molecular entity, it has been granted two “Fast Track Designations” and one “Orphan Drug Designation” by the U.S. FDA, and has received support from the National “Major New Drug Creation” Science and Technology Major Project under the 13th Five-Year Plan.

As the first traditional Chinese medicine (TCM) fund in China initiated by state-owned capital, the Guangdong TCM Health Industry Fund was established in 2021 under the guidance of the National Administration of Traditional Chinese Medicine. It was jointly initiated by China Development Bank Capital Co., Ltd., a wholly-owned subsidiary of the China Development Bank; Guangdong Hengjian, Guangdong’s state-owned capital operation platform; and the Guangzhou Development District. The fund has a total scale of RMB 30 billion, with an initial scale of RMB 5 billion. Leveraging the developmental finance advantages of the China Development Bank and the systemic resource strengths of Guangdong Province, the fund supports the research and development, transformation, and industrial promotion of technologies related to the TCM industry. It also appropriately expands the connotation and extension of the TCM industry, focusing on delivering high-quality products and services to China’s broader health sector.

As the private equity fund management platform under Yuexiu Financial Holdings, Yuexiu Industrial Investment Fund has managed a cumulative fund size exceeding RMB 100 billion since its establishment in 2011. In the biopharmaceutical sector, the company drives investment through in-depth research, continuously integrates industrial resources, empowers portfolio companies, and contributes to building a robust biopharmaceutical ecosystem. To date, it has invested in more than 50 biopharmaceutical companies, including high-quality enterprises across various sub-sectors such as Sirnaomics (2257.HK), CanSino Biologics, Hankang Biotech, HighTide, Yuanyang Medicine, Moonshot Biotech, Yinhang Biotech, Jiayue Pharmaceutical, and Xukang Medical.