CordenPharma has announced plans to acquire AmbioPharm, a move aimed at strengthening its peptide active pharmaceutical ingredient (API) manufacturing capabilities and expanding its global production network.

Mabwell (688062.SH), an innovation-focused biopharmaceutical company with an integrated value chain, has announced that the National Medical Products Administration (NMPA) has accepted the Investigational New Drug (IND) application for its novel LILRB4/CD3 T cell engager (TCE) bispecific antibody, 6MW5311. This candidate is being developed to treat hematologic cancers, including Acute Myeloid Leukemia (AML), Chronic Myelomonocytic Leukemia (CMML), and Multiple Myeloma (MM).

6MW5311 is the first LILRB4/CD3 TCE bispecific antibody worldwide to reach the clinical trial application stage, highlighting its strong development potential and promising commercial outlook. In the United States, the IND process is currently at the pre-IND stage, with a formal submission to the FDA planned for the second quarter of 2026.

Built on a T cell engager platform, 6MW5311 features a “2+1” asymmetric design that enables it to bind simultaneously to LILRB4 on tumor cells and CD3 on T cells. This dual targeting facilitates the formation of an immune synapse, activating T cells to effectively attack cancer cells.

The molecule also incorporates a distinctive steric hindrance mechanism that limits CD3 binding in the absence of tumor cells. As a result, T cells are primarily activated only when tumor cells are present, which enhances safety while maintaining strong anti-tumor activity.

Preclinical in vitro studies have shown that 6MW5311 demonstrates robust cytotoxic effects across various tumor cell lines and patient-derived samples. In vivo studies further indicate significant tumor suppression in both high and low LILRB4-expressing AML models, with complete tumor elimination observed in high-expression cases. Additionally, safety evaluations in cynomolgus monkeys suggest a favorable safety profile.

T cell engager therapies represent an important strategy for directing immune cells to target cancer, and they have already shown meaningful clinical success in several lymphoma indications, with multiple approved products. However, treatment options for AML and CMML are still largely limited to chemotherapy, stem cell transplantation, and mutation-specific targeted therapies. To date, no TCE therapies have been approved for these diseases.

In 2006, Tomas Cihlar was well aware that, despite initial successes with combination therapy, HIV continued to be a global challenge with limited treatment options. At the time, he had been researching virology at Gilead for 12 years, and the first once-daily, single-tablet regimen for HIV treatment was still awaiting approval. People living with HIV had to rely on multiple daily medications, which often caused severe side effects or led to drug resistance.

“That challenge kept the Gilead research team motivated and reinforced our urgent need to develop something new,” recalls Tomas, now Senior Vice President of Research Virology.

After a decade of dedicated work, the team achieved a significant breakthrough, discovering a molecule that could transform the battle against HIV.

“In the beginning, if someone had told me where we’d eventually end up, I would have thought they were dreaming,” Tomas says with a smile. “What we discovered was completely unprecedented.”

At that time, most HIV treatments worked by targeting the viral enzymes responsible for replication and spread. However, Tomas had a different approach in mind—one that focused on the viral capsid, a cone-shaped protein structure that protects the genetic material essential for reproduction. While many scientists believed the capsid was too difficult to target, Tomas was convinced otherwise. “If we could disrupt the capsid, we might be able to stop the virus altogether,” he explains.

The research team screened hundreds of thousands of compounds, searching for one that could effectively interfere with the capsid’s function. However, their early findings were too weak to serve as viable drug candidates.

By 2009, the project faced a major roadblock, and a solution seemed out of reach. But in January 2010, Tomas attended a medical conference where a poster presentation sparked an “aha” moment, providing fresh inspiration.

“That moment revitalized our research and gave us a new direction,” he recalls.

Over the next six years, Gilead scientists synthesized and tested more than 4,000 molecules, eventually discovering a novel compound that proved exceptionally potent even at very low doses. When introduced into the human body, the molecule remained stable for several months without degrading while retaining its ability to fight the virus.

“The journey of Gilead is one of innovation, collaboration, resilience, and perseverance, and this discovery was undoubtedly a breakthrough,” Tomas reflects.

Appropriately, Breakthrough: The Quest for Life-Changing Medicines, a newly published book on medical innovation by physician-scientist and biopharmaceutical executive Dr. William Pao, explores the process of drug discovery. It highlights eight transformative medications, including Gilead’s new HIV treatment, detailing the challenges and unexpected moments that shaped their development.

“There have been many HIV treatments, but this one is truly groundbreaking,” William explains. “It represents a completely new way of thinking about the virus and targeting it. Its discovery also required a willingness to embrace unexpected opportunities—turning an insoluble molecule with a long half-life into a subcutaneous medicine.”

As Pao emphasizes in his book, drug discovery and development involve countless individuals and significant trials.

“Every drug development project has its highs and lows. Teams persist not for personal recognition, but to improve patients’ lives,” he says.

Gilead’s story is no exception.

“The unwavering commitment of hundreds of people—from Gilead’s research and development teams to external collaborators and clinical trial participants—made this achievement possible,” Tomas states. “This story demonstrates what can be accomplished when we set ambitious goals and work together to achieve them.”

Recent clinical trial results suggest that this drug could potentially prevent HIV transmission entirely. If regulatory approval is granted, Gilead has already developed a global access strategy to ensure its availability in low- and middle-income countries.

We’re honored to once again be recognized among the top five most just companies in the biopharmaceutical industry in the United States. This recognition highlights our continued dedication to responsible business practices and empowering our workforce to contribute to a healthier global community.

Gilead Sciences, Inc. is a science-driven biopharmaceutical organization focused on discovering, developing, and bringing to market groundbreaking treatments for areas with significant unmet medical needs. The company is committed to improving and streamlining care for individuals facing life-threatening conditions across the globe. Gilead operates in more than 35 countries, with its main headquarters located in Foster City, California.

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