Yunnan Baiyao Acquires Preclinical Antibody Drug KA-1641 for RMB 38 Million to Expand Oncology Pipeline

On June 28, Yunnan Baiyao Group Co., Ltd. (hereinafter referred to as “Yunnan Baiyao”) issued an announcement stating that it will license the relevant patents for KA-1641, a self-developed antibody drug, from KYinno Biotechnology Co., Ltd. (hereinafter referred to as “KYinno”), and will conduct research and development, manufacturing, and commercialization of the target product on a global scale.

The announcement stated that Yunnan Baiyao will make a one-time upfront payment of RMB 6 million to KYinno, along with RMB 32 million in research and development (R&D) and regulatory milestone payments. Both parties intend to continue jointly advancing the project’s R&D based on current progress, with the ultimate goal of achieving regulatory approval and commercialization of the relevant pharmaceutical products. In addition to the upfront and milestone payments, Yunnan Baiyao is also required to pay sales royalties and share revenues from overseas licensing.

KA-1641 is a monoclonal antibody drug independently screened by KYinno via hybridoma technology, with relevant patents currently under substantive examination. The primary indication is cancer cachexia.

According to the "Clinical Diagnosis and Treatment Guidelines for Cancer Cachexia (2020 Edition)," cancer cachexia (also known as cancerous cachexia) has a high incidence rate and is a common complication in various advanced malignant tumors. It is characterized by the wasting of skeletal and visceral muscles, accompanied by multiple clinical manifestations such as loss of appetite, anorexia, early satiety, weight loss, muscle atrophy, fatigue, anemia, edema, and hypoalbuminemia. Reports indicate that 60%–80% of cancer patients may develop cachexia, and approximately 20% of cancer patients die from cancer cachexia.

According to Fortune Business Insights, the global market size for cancer cachexia was USD 2.02 billion in 2019 and is projected to reach USD 3.76 billion by 2032, representing a compound annual growth rate (CAGR) of 5.0% during the forecast period. Furthermore, the rising prevalence of malignant tumors worldwide has led to an increasing incidence of cachexia, driving market growth through a surge in demand for effective treatments.

Clinical management of cancer cachexia primarily involves nutritional and pharmacological interventions. The consensus only recommends progestin analogs, glucocorticoids, and traditional Chinese medicine as adjunctive therapies to improve patients’ appetite.To date, the FDA has not approved any drugs for the treatment of cancer cachexia.

In the R&D sector, anamorelin (developed by Ono Pharmaceutical, Japan), the world’s first drug for treating cancer cachexia, was launched in Japan in 2021. As a selective ghrelin receptor (GHS-R1a) agonist, it remains a focal point of research in targeted therapy for cancer cachexia.

Apart from anamorelin, the innovative drug pipeline for treating cancer cachexia primarily focuses on growth differentiation factor 15 (GDF15), known as the “anorexia hormone.” Activation of its receptor, the GFRAL protein, can lead to reduced food intake and weight loss. Three monoclonal antibody drugs—Pfizer’s Ponsegromab, Germany-based CatalYm’s Visugromab, and US-based NGM Bio’s NGM120—have all entered Phase II clinical trials. Among them, Phase Ib study data for Ponsegromab showed that the drug reduced circulating GDF15 levels in patients to those seen in healthy individuals. Patients with cachexia participating in the study experienced an average weight gain of 6.5%, along with significant improvements in physical function.

According to the announcement, KA-1641 is currently in the preclinical stage of manufacturing process research and development, and no publicly available information on its target has been found. The risk disclosure in the announcement notes that no products targeting the same mechanism as KA-1641 have yet been approved for market launch.

KYinno focuses on R&D services and customized products for next-generation innovative oncology drugs. It has established over 8,000 engineered cell lines with stable expression and transient transfection capabilities, covering emerging novel targets in innovative drug development. The company provides drug screening and efficacy evaluation services, both in vitro and in vivo, based on these engineered cell lines.

It is reported that KYinno has established a patented platform for common light chain bispecific antibody discovery in mice, a nanobody discovery mouse platform, and the MPSA-AB5000 high-throughput off-target screening technology platform for CAR-T or antibody drugs. By combining traditional hybridoma immunization with single B-cell sequencing technology, the company can rapidly and efficiently screen for and discover antibody-based therapeutics.

As its industry-leading cell line library and proprietary platform have matured, KYinno has maintained a steady stream of public activities in recent years. At the 2024 AACR (American Association for Cancer Research) Annual Meeting, KYinno presented its antibody platform and research findings on multiple bispecific antibodies in poster format, including KA-3003 (PSMA/CD28/4-1BB), KA-3007 (B7H3/CD28), KA-3004 (PD-L1/4-1BB), KA-3001 (PSMA/CD28), KA-3002 (PSMA/4-1BB), KA-3005 (MET dual epitope), KA-3006 (EGFR/MET), KA-3008 (EGFR/B7H3), and KA-3009 (EGFR/B7H3/4-1BB).

An analysis of recent developments reveals that Yunnan Baiyao prioritizes the integrity and synergy of its subsequent innovative drug portfolio as it expands its business footprint beyond traditional Chinese medicine. The announcement noted that KA-1641 will enhance the company’s competitiveness in the field of oncology innovative drugs alongside its existing radiopharmaceutical product line, aligning with its strategic direction for innovative drug development.

Since 2022, Yunnan Baiyao has been strategically positioning itself in the development of innovative drugs centered on radiopharmaceuticals. In June 2022, aligning with national strategic needs for medical isotopes and leveraging Peking University’s strengths in nuclear medicine research, Yunnan Baiyao established the Innovative Drug Center under its Central Research Institute. The center focuses on areas such as oncology and immunology, aiming to build an innovative drug R&D pipeline anchored by precision diagnostics and therapeutics, with a distinctive advantage in radiopharmaceuticals. In September 2022, Yunnan Baiyao licensed patents related to prostate-specific membrane antigen (PSMA)-targeted radiopharmaceuticals from Peking University First Hospital and the Beijing Institute for Cancer Research, officially launching its radiopharmaceutical R&D initiatives.

In June 2023, Yunnan Baiyao established Yunhe Pharmaceutical as a wholly-owned subsidiary, with plans to build a 6,000-square-meter radiopharmaceutical R&D center in Tianjin. In early January 2024, Yunhe Pharmaceutical obtained approval for the environmental impact assessment form for its Tianjin radiopharmaceutical R&D center project (involving the new construction, use, and sale of radioactive drugs) and officially commenced construction, which will effectively support the development of its innovative radiopharmaceutical pipeline in the future.

In May, INR101, a Class 1 chemical innovative radioactive diagnostic drug developed by Yunhe Pharma, received implicit approval for clinical trials from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The indicated use is PET imaging of PSMA-positive lesions in patients with prostate cancer. The innovative radiopharmaceutical INR102, designed for the treatment of prostate cancer, has completed early efficacy validation in animal models and initiated pharmaceutical studies. Research on candidate molecules for projects such as INR202 and INR203 has also been successively launched.

Through pipeline in-licensing, collaborative R&D, and capacity expansion, Yunnan Baiyao, with its mature research and management systems, has made rapid progress in advancing innovative drugs. The recent introduction of an antibody drug pipeline marks a significant step in the company’s portfolio expansion.

On the one hand, introducing this antibody drug helps enrich its innovative drug R&D portfolio. In the future, it can form a distinctive oncology product matrix alongside radiopharmaceutical diagnostic and therapeutic products, enabling synergistic development and fully leveraging the in-hospital oncology channels to be established in the future.

On the other hand, leveraging this project as an opportunity, Yunnan Baiyao will integrate the R&D chain from preclinical development to clinical research of antibody drugs, thereby accumulating experience and laying a foundation for the subsequent in-house development or introduction of other innovative drugs.

In addition to Yunnan Baiyao, traditional Chinese medicine enterprises such as Tasly Pharmaceutical, Pien Tze Huang Pharmaceutical, and China Resources Sanjiu are actively expanding their business footprints into non-traditional Chinese medicine sectors.

In June, Pien Tze Huang Pharmaceutical announced that its Class 1 innovative chemical drug with independent intellectual property rights, PZH2113 capsules (utilizing protein degradation technology), had received the "Notice of Approval for Drug Clinical Trials" from the National Medical Products Administration. The drug is intended for the treatment of relapsed/refractory non-Hodgkin lymphoma, primarily diffuse large B-cell lymphoma (DLBCL).

As early as 2020, PZH2111 tablets, the first Class 1 innovative chemical drug independently developed by Pien Tze Huang, received approval from the National Medical Products Administration (NMPA) to initiate clinical trials. The drug is primarily indicated for the treatment of advanced solid tumors, such as intrahepatic cholangiocarcinoma and urothelial carcinoma with FGFR gene alterations. To date, Pien Tze Huang Pharmaceutical Co., Ltd. has four innovative traditional Chinese medicine (TCM) drugs and three innovative chemical drugs undergoing clinical studies, while two innovative chemical drugs and four classical prescriptions are in the preclinical research stage. These pipelines cover multiple therapeutic areas, including oncology, pain management, and neuropsychiatry.

For traditional Chinese medicine (TCM) enterprises, abundant cash flow, mature commercialization channels, and years of accumulated commercial expertise constitute their prominent advantages. Beyond further developing classic TCM formulas and innovative TCM drugs, expanding into the research and development of Class 1 innovative chemical and biological drugs that are acceptable to mainstream global pharmaceutical markets is not only an inevitable trend in the modernization of TCM enterprises but also a critical step in broadening industrial boundaries and identifying new growth engines.