Adlumia BioPharma Files IPO Prospectus: Aiming to Transform Cancer into a Non-Fatal Disease Through Innovative Immunotherapies

Curing cancer has long remained a global challenge. In the face of tumor cells capable of unlimited replication and prone to metastasis, the medical community has been striving to develop treatments based on the specific characteristics of these cells. Current therapeutic approaches primarily include surgical resection of tumors, radiation and chemotherapy to kill cancer cells, and targeted therapy to induce specific death of cancer cells.

However, these traditional treatments have inherent drawbacks, such as incomplete efficacy and a high risk of recurrence. In contrast, tumor immunotherapy leverages the patient’s own immune system to eliminate cancer cells; this advantage has created market opportunities for novel therapies.

● Tumor immunotherapy is a treatment method that controls and eliminates tumor cells by enhancing the body's anti-tumor immune response and inhibiting the immune escape of tumor cells.

Adlai Nortye is one of the players in this new market.

Adlai Nortye was officially established in 2016. Its founder, Lu Yang, was born into a family with a long-standing tradition in the pharmaceutical industry. Influenced by his family environment from an early age, he developed a strong interest in biology.

In 1998, Lu Yang fulfilled his aspiration to study biology at Xiamen University, laying a solid knowledge foundation for his future career in the healthcare sector. After graduation, he applied to the China Europe International Business School (CEIBS) to pursue an Executive Master of Business Administration (EMBA) degree, as robust business management capabilities are essential for the commercial operations of startups.

Lu Yang, Founder of Adlai Nortye Biopharma

Lu Yang has remained deeply committed to the biomedical sector. From his first role at Hybio Pharmaceutical (China’s first peptide drug development company), where he managed marketing and sales for CRO and CMO services, to launching his first venture a year later—Boxin Biology, which specializes in PCR-based diagnostic reagents—Lu Yang has consistently combined his biological expertise with managerial acumen, advancing through both professional practice and entrepreneurship.

At the end of 2004, due to disagreements with partners over the company’s strategic direction, Lu Yang sold his shares in Boxin Bio. Recognizing that the healthcare industry offered ample room for startup growth and held broad prospects, he founded Nuotai Pharmaceutical, the predecessor of Adlai Nortye Biopharma.

This is the first peptide pharmaceutical company in China to have its peptide drug U.S. DMF filing accepted.

The company has been in operation for 11 years, during which Lu Yang has accumulated 11 years of experience in drug development and commercial management.

However, the good times did not last. Nuotai Pharmaceutical was affected by compliance issues with the leased facility used for drug production, which halted its manufacturing operations. The company’s cash flow broke down at one point, and it was unable to establish a new plant. Ultimately, Lu Yang had no choice but to divest Nuotai Pharmaceutical’s generic drug business.

Following the divestiture of its generic drug business, Lu Yang decided to restructure Nuotai Pharmaceutical by converting the company from a limited liability company into a joint-stock limited company, and elected the first board of directors and board of supervisors. Meanwhile, the company was renamed “Hangzhou Adlai Nortye Biopharma Technology Co., Ltd.” (hereinafter referred to as “Adlai Nortye”).

At this point, Adlai Nortye Biopharma was officially established, marking a significant shift in its core business.

Adlai Nortye Biopharma is a modern biopharmaceutical company dedicated to developing innovative drugs based on the mechanism of tumor immunotherapy. When asked about the company’s positioning, founder Lu Yang stated that Adlai Nortye’s mission is to transform cancer into a non-fatal disease or even achieve a cure through the research and development of innovative medical approaches, thereby extending human lifespan.

Adlai Nortye Biopharma currently has more than ten investigational products in the field of tumor immunotherapy. Among them, AN9015, a small-molecule inhibitor targeting CSF1R for tumor immunotherapy, is about to enter Phase I clinical trials; AN0025, an oral antagonist of the E-type prostate receptor 4, is about to enter Phase II clinical trials; and REOLYSIN®, an oncolytic virus, is progressing the fastest and is about to enter Phase III clinical trials.

REOLYSIN® is an oncolytic virus under Oncolytics Biotech Inc., and Adlai Nortye has obtained exclusive commercialization rights for this virus in China, Singapore, and South Korea.

REOLYSIN® is a safe reovirus. After intravenous administration, it selectively infects and destroys tumor cells. Its therapeutic mechanism is akin to fighting poison with poison.

However, the first “toxin” is not only non-lethal but also helps us destroy the second “toxin”—tumor cells. Oncolytic viruses can directly kill tumor cells and are expected to stimulate the body’s immune response, converting “cold tumors” into “hot tumors,” thereby enhancing anti-tumor efficacy.

This product is primarily indicated for the treatment of various solid tumors. REOLYSIN® has currently been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) and is poised to enter global Phase 3 clinical trials for the treatment of metastatic breast cancer.

Drug development has always been a highly challenging endeavor. The team at Adlai Nortye Biopharma comprises seasoned experts from leading overseas pharmaceutical companies and graduates from China’s top-tier “Double First-Class” universities, boasting extensive experience in innovative drug research and development as well as clinical trials. To date, the company has attracted more than 20 overseas-trained scientists to join its ranks.

The company mitigates overall operational risk by licensing late-stage R&D products from overseas, while concurrently pursuing independent research and development of novel targets. In addition to its in-house R&D efforts, the team collaborates with enterprises in Canada, Japan, and other countries on drug innovation, bringing new hope to cancer patients worldwide.

Currently, all of the company's innovative drugs are in the clinical trial stage, and it has not yet generated revenue from pharmaceutical product sales. However, upon completion of the clinical trials and receipt of production approval for these innovative drugs, Adlai Nortye Biopharma's total revenue will increase rapidly due to the addition of drug sales profits.

Adlai Nortye Biopharma Co., Ltd. has established partnerships with renowned domestic and international enterprises and academic institutions within just two years of its restructuring. Its key domestic partners include Genor Biopharma, Guokuang Pharma, the Chinese Academy of Medical Sciences, and the Peking University Shenzhen Graduate School, with several collaborative projects signed for the joint development of tumor immunotherapies (including PD-1/L1, IDO, and anti-PD-1 monoclonal antibodies).

In recent years, Adlai Nortye Biopharma has maintained a strong focus on the oncology sector, participating in the American Society of Clinical Oncology (ASCO) Annual Meeting and the International Biopharmaceutical Innovation Summit. In November 2017, the company secured exclusive rights to develop and market REOLYSIN®, an oncolytic virus from Canada’s Oncolytics Biotech Inc., in China, Singapore, and South Korea.

In January 2018, the Company entered into a collaboration with Eisai Co., Ltd. (Eisai) of Japan, obtaining exclusive global development and commercialization rights for the AN0025 antagonist, excluding certain parts of Asia.

In July 2018, through a collaboration with global pharmaceutical giant Novartis, the company secured exclusive global rights to develop, manufacture, and market the oncology therapeutic Buparlisib (AN2025), via an agreement structured with an upfront payment, milestone payments, and sales royalties.

Following the completion of its $8 million Series A financing in 2015, Adlai Nortye Biopharma closed its Series B financing this June, raising $53 million. The Series B round was jointly invested by Matrix Partners China, Yuanming Capital, DT Capital Partners, and Yahui Investment.

Lu Yang stated that the proceeds from this financing will be primarily used by Adlai Nortye Biopharma for clinical studies, as well as for capital investments with certain partners. Adlai Nortye Biopharma will continue its efforts in developing innovative drugs for cancer immunotherapy, aiming to benefit more cancer patients.

“We will continue to advance these clinical products and expand R&D collaborations with partners in the field of tumor immunotherapy, keeping pace with market developments,” revealed founder Lu Yang.

It is reported that Adlai Nortye Biopharma’s pipeline products expected to be launched by listed companies in 2021 include Buparlisib® for the treatment of head and neck squamous cell carcinoma (HNSCC) and Reolysin® for the treatment of metastatic breast cancer (mBC).