From a 300-square-meter laboratory in Shanghai's Zhangjiang Pharma Valley to plans for expanding capacity to over 160,000 liters in Lingang Life Blue Bay, how has Top Alliance, in just 13 years, built a pipeline of over 50 innovative drugs and risen to join the ranks of mainstream international biopharmaceutical companies?

"The shift from 'single-point breakthroughs' to 'platform-based innovation' has enabled Top Alliance to break through barriers continuously in R&D, commercialization, and internationalization," said Xiong Jun, Chairman of Top Alliance, with conviction during a recent research interview with Shanghai Securities News, revealing the code to the company's growth.

Xiong Jun's confidence stems from the global breakthrough of Top Alliance's core product, the anti-PD-1 monoclonal antibody Toripalimab. Today, Toripalimab has long transcended its status as a mere candidate drug in the lab, becoming the first self-developed and self-produced innovative biologic from China to receive approval from the U.S. FDA and a "China name card" available in over 40 countries and regions worldwide.

The innovative breakthrough of Toripalimab represents not just the success of a single drug but also marks a paradigm shift for China's original innovative drugs from "introducing in" to "going global." "The 15th Five-Year Plan period will be a critical window for Chinese innovative drugs to go global. We must ensure that domestic innovative drugs gain a firm foothold on the world stage," declared Xiong Jun with resounding clarity.

From "Follower" to "Leader"

In the laboratory on Cailun Road in Shanghai's Zhangjiang, process characterization and optimization equipment hums at high speed, as if narrating the arduous journey of Top Alliance's innovative breakthroughs. "Over a decade ago, the field of tumor immunotherapy in China was almost entirely dominated by imported drugs. We started from scratch to develop a domestic anti-PD-1 monoclonal antibody because we genuinely wanted to address the pain points of Chinese patients—having no drugs available or facing exorbitant costs," recalls Xiong Jun.

At that time, international giants had already seized the first-mover advantage in the PD-1 race, leaving Top Alliance in the position of a "follower." However, the company did not take the conventional path of simple replication. Instead, it focused on locally prevalent cancers such as nasopharyngeal carcinoma and esophageal cancer, aiming to carve out a market niche through differentiation.

Ultimately, in late 2018, Toripalimab (brand name: Tuoyi) emerged as the first domestically developed anti-PD-1 monoclonal antibody to gain approval. This not only broke the monopoly of imported drugs but also marked a critical leap for China's innovative drugs from "following" to "running alongside" global peers.

The true breakthrough into "leadership" occurred in 2023, when Toripalimab received approval from the U.S. FDA. It became the first self-developed and self-produced innovative biologic from China to gain FDA approval and the first drug for nasopharyngeal carcinoma treatment in the United States, a milestone that inspired China's biopharmaceutical industry. Behind this "global recognition" lies the tireless efforts of countless Top Alliance employees.

Looking back to 2021, Top Alliance's production and quality teams were in full preparation for the FDA manufacturing inspection: translating over 10 million words of related documents, with Quality Head Wang Gang developing more than 300 practice questions based on experience and creating "mini-PPTs" for drills. Prior to the inspection, the company conducted five consecutive mock audits, inviting international GMP experts to identify gaps through remote and on-site reviews, comprehensively benchmarking against international standards to address weaknesses.

During the on-site inspection in May 2023, FDA inspectors raised over 300 questions. The Top Alliance team, involving more than 150 personnel, responded calmly and delivered satisfactory answers, enabling Toripalimab to successfully represent China's innovative drugs on the global "leadership" track.

Today, Toripalimab has penetrated major markets such as the United States and the European Union and is expanding into emerging regions like the Middle East and Africa. In China, the drug has been approved for 12 indications, with 10 included in the 2025 National Reimbursement Drug List (NRDL)—four of which are exclusively covered under the NRDL. The marketing application for its 13th indication was also accepted by the NMPA in August 2025.

From "Single-Point Breakthrough" to "Platform-Based Innovation"

"The success of a single drug may be coincidental, but the success of a portfolio of drugs is inevitable," says Xiong Jun, who views Toripalimab's breakthrough as merely the starting point for Top Alliance's broader innovative drug strategy.

From its origins in a 300-square-meter lab, Top Alliance's R&D pipeline now clearly spans five major therapeutic areas and comprises over 50 innovative drug candidates. This outlines a product echelon strategy characterized by "one generation on the market, one in clinical trials, and one in reserve."

Anchored by Toripalimab, the company's innovative efforts have expanded into multiple modalities, including monoclonal antibodies, bispecific antibodies, small molecule drugs, antibody-drug conjugates (ADCs), and fusion proteins. This has resulted in a pipeline matrix that balances "deep cultivation in established fields" with "strategic expansion into frontier areas."

In 2025, Top Alliance advanced several globally competitive innovative drugs into domestic clinical trials, including the EGFR/HER3 bispecific ADC (JS212), the PD-1/IL-2 bifunctional fusion protein (JS213), and a monkeypox vaccine (JT118). As of Q3 2025, the company has 4 commercialized drugs, nearly 30 candidates in clinical trials, and over 20 in preclinical research.

Innovation extends beyond pipeline composition to pushing therapeutic boundaries. "The company is exploring combination therapies involving our products with chemotherapy, monoclonal antibodies, ADCs, and other drugs to address unmet clinical needs and market gaps," Xiong Jun revealed.

"In the next five years, competition in the biopharma industry will shift from 'single-point breakthroughs' to 'platform-based innovation,' with next-generation therapies redefining treatment boundaries," Xiong Jun stated. He believes complex therapies like bispecifics and ADCs will become the core of future R&D. Coupled with advances in AI-assisted research, China's path to leadership in biopharmaceuticals is becoming increasingly clear.

During the 15th Five-Year Plan period, Top Alliance plans to advance more products into Phase III clinical trials and registration. The company aims to develop new "blockbuster candidates" from cutting-edge pipelines such as the PD-1/VEGF bispecific antibody (JS207), the EGFR/HER3 bispecific ADC (JS212), and the PD-1/IL-2 bifunctional fusion protein (JS213), achieving continuous self-iteration.

From "R&D-Driven Enterprise" to "Integrated Industry Chain Operator"

"The value of innovative drugs is ultimately reflected in clinical application, and this value transcends national borders," Xiong Jun told the reporter. Following the successful international expansion of Toripalimab, Top Alliance has formally begun its transformation from an "R&D-driven enterprise" into an "integrated industry chain operator," with internationalization undoubtedly becoming the company's most significant highlight over the next five years.

At its Shanghai Lingang base, bioreactors are operating at full capacity. This facility serves not only as an accelerator for the commercialization of innovative drugs but also embodies Top Alliance's global ambitions. The company has established fully self-sufficient production capabilities spanning the entire process, from monoclonal antibody manufacturing and high-efficiency toxin conjugation to formulation, filling, and lyophilization, solidifying the industrial foundation for further globalization.

On the global commercialization front, Top Alliance employs a hybrid-driven model of "collaboration + partial self-operation." By leveraging the established channels of international partners such as Coherus, Hikma, and LEO Pharma, the company has rapidly built a commercial network covering over 80 countries. Simultaneously, it has independently established commercial teams in places like Singapore, gaining hands-on experience in "building its own ships to sail overseas."

"Starting from Shanghai's Zhangjiang to reaching international markets, we have completed in 13 years a journey that took decades for pharmaceutical companies in developed countries," Xiong Jun remarked frankly. During the "15th Five-Year Plan" period, Top Alliance's globalization strategy will advance to deeper levels: in terms of markets, the company will further expand into emerging regions such as Southeast Asia; in R&D, it plans to collaborate with international institutions to address unmet clinical needs; and in production, it will establish an industrial framework of "global R&D + regional production."

Reference：https://finance.eastmoney.com/a/202512023579790339.html