Since the launch of Mylotarg, the first ADC drug, in 2000, interest in antibody-drug conjugates (ADCs) has grown steadily year by year, reaching a peak with the emergence of Daiichi Sankyo’s DS-1208. Enthusiasm for ADC research and development in the Chinese market is also at an all-time high, with major pharmaceutical companies actively establishing their presence in this field.
On June 9, 2021, RemeGen’s RC-48 (Aidixi) received marketing approval from the National Medical Products Administration (NMPA). Two months later, the drug “embarked on its global journey,” as RemeGen entered into an exclusive global licensing agreement with Seagen for $2.6 billion, setting a new record at the time for overseas out-licensing deals involving a single Chinese-developed product. The success of this first antibody-drug conjugate (ADC) independently developed in China created significant waves in the pharmaceutical industry, elevating public enthusiasm for the ADC market to new heights.
However, as ADC drugs have garnered significant enthusiasm from the capital market, this sector has become overheated. With R&D pipelines crowded together, it has effectively turned into a red ocean. At this juncture, choosing to develop other promising conjugate therapeutics may offer companies a better opportunity to achieve “overtaking on a bend.”
Peptide-Drug Conjugate (PDC)It is precisely such a high-potential asset, and alsoShenzhen Tyercan Bio-pharmaceutical Technology Co., Ltd. (Tyercan Bio-pharm Co., Ltd., hereinafter referred to as “Tyercan Bio”)Flagship Innovative Drug Candidates Under Development. The company maintains a diverse portfolio of investigational products and multiple development pipelines, with a current focus on the development of targeted anticancer agents and targeted immunosuppressive therapies.
The mechanism of action of peptide-drug conjugates (PDCs) is similar to that of antibody-drug conjugates (ADCs). PDCs involve conjugating cell-targeting peptides with small-molecule cytotoxins, thereby conferring receptor-targeted specificity to previously non-targeted drugs. This approach delivers the drug to tumor-specific sites, enhancing therapeutic efficacy while reducing its relative concentration in other tissues, thus minimizing adverse effects.
Compared with ADC drugs,PDC drugs are hailed as “next-generation targeted anti-tumor agents” due to their advantages, including ease of synthesis and optimization, negligible or low immunogenicity, enhanced tumor penetration, and lower cost.
On February 26, 2021, Pepaxto (melphalan flufenamide, also known as melflufen), a peptide-drug conjugate (PDC) developed by Oncopeptides, received accelerated approval from the U.S. FDA, becoming the second PDC drug to be marketed globally and sparking a wave of interest in PDC therapeutics.
Currently, more than seven products have entered clinical trials globally, with companies such as Bicycle Therapeutics and Cybrexa Therapeutics demonstrating rapid and active R&D progress. In China, the trend of PDC drug development is also gaining momentum rapidly. It is understood that at least four pharmaceutical companies in China are currently engaged in the R&D of PDC-related products, among which Taierkang Bio is one.
Telkang Biopharma is located in the National Biomedical Innovation Industrial Park in Pingshan District, Shenzhen. Since its official launch in September 2019, the company has primarily focused on developing original innovative drugs for major disease areas, including malignant tumors, organ transplantation, and autoimmune diseases. The core team members of Telkang BiopharmaHe has long been engaged in biomedical development in the United States, accumulating nearly 30 years of experience in the research and development of peptide drugs and Peptide-Drug Conjugates (PDCs), and has successfully developed multiple targeted therapies.
Dr. Lichun Sun, Founder and CEO of Taierkang Biotech, graduated from Fudan University, and subsequently conducted postdoctoral research at the Peptide Drug Center of a renowned university in New Orleans, USA, where he advanced from a postdoctoral fellow to Full Professor. Over the past two decades, Dr. Sun has been dedicated to peptide technology and targeted drug development, accumulating extensive experience in drug development and successfully bringing multiple new drug products to market. Dr. Sun is the leader of a Shenzhen Overseas High-Level Innovation Team. In addition to his academic achievements, he possesses rich industry experience as one of China’s earliest entrepreneurs during the Reform and Opening-up era. He founded Xiamen Tailun Bioengineering Co., Ltd. as its Founder and CEO, developed the “Two-and-a-Half Pairs” diagnostic kit for hepatitis B, obtained five national regulatory approvals, and launched products that achieved long-term best-selling status in the domestic market.
Dr. Zheng Qiping, Vice President of Telkang BiotechDr. Zheng and Dr. Sun were classmates at Fudan University. After earning his Ph.D., Dr. Zheng completed postdoctoral training at Baylor College of Medicine in Houston, USA, and subsequently conducted independent research at a prestigious university in Chicago, where he was appointed as a tenure-track Assistant Professor and later promoted to Associate Professor. Dr. Zheng is also a leading talent in Jiangsu Province’s “Mass Innovation and Entrepreneurship Team.” He previously worked at Quintiles (now IQVIA), a renowned clinical research organization based in Atlanta, where he accumulated extensive laboratory and team management experience in basic and clinical research on oncology and developmental biology, as well as in product development.
Core Members of Telkang BioDr. Li Min, CMO, has been a colleague of Dr. Lichun Sun for many years. He previously worked for an extended period at a Nobel Prize-winning laboratory at a prestigious university in New Orleans, USA, and was appointed Associate Professor. Dr. Li Min is the CEO of a Japanese clinical trial company, holds multiple PCT international invention patents and candidate drug projects, and possesses extensive experience in clinical development.
Motivated by the stark reality of the gap between China and the United States in innovative drug R&D, as well as the current growth potential of China’s innovative drug market, several scientists with extensive industry experience have decided to return to China to launch startups. They aim to leverage their accumulated technical expertise and experience to develop a portfolio of innovative drugs, particularly peptide-drug conjugate (PDC)-based therapeutics, in order to meet the growing demand for antitumor and immunosuppressive agents, thereby benefiting patients and society at large.
Leveraging its strong team capabilities and the advanced nature of its projects, Taierkang Biotechnology received substantial support from the Shenzhen Municipal Government in its early stages. It was selected as a funded project under Shenzhen’s Overseas High-Level Innovation Team Program. The company is currently undergoing angel-round financing to accelerate the development of its core drug pipeline and expand its team.
Leveraging its innovative U.S.-based peptide targeting technology platform, Telkang Bio currently has multiple products in development and several product pipelines, with its primary focus onAntitumor Targeted Drugs and Immunosuppressive Targeted Drugsdevelopment. Among them, several products are targeted drugs developed based on the small-molecule compound X3 (and X5).
X3 is a small-molecule compound with potent antitumor activity, but its significant side effects pose substantial challenges to drug development. X5 is a classic immunosuppressant widely used in organ transplantation; however, due to its considerable adverse effects, its application is restricted to organ transplantation and cannot be extended to dozens of other autoimmune diseases.
Taierkang Biotechnology utilizes specific peptide-targeting carriers to conjugate these small-molecule compounds, which demonstrate significant efficacy but also considerable toxic side effects, thereby forming relevant peptide-drug conjugates. This approach enhances their target specificity and therapeutic efficacy while reducing the required dosage and associated toxicity, making the clinical development of X3 feasible and enabling the broader application of X5 in organ transplant recipients and other autoimmune diseases, thus significantly expanding its therapeutic scope.
Dr. Zheng Qiping told VCBeat,Tai Erkang Biotech’s carrier technology enables precise 1:1 conjugation of small-molecule compounds with the carrier, thereby reducing the toxic side effects of the small-molecule compounds and facilitating effective drug purification.This approach enhances the safety and efficacy of the drug while ensuring the quality and stability of batch production, advantages that traditional antibody-drug conjugates (ADCs) do not possess.
Telcom BiotechThe two most advanced product candidates, Tye-1001 and Tye-1002, are both being developed for oncology indications.Among them, Tye-1001 is a broad-spectrum anti-tumor conjugate drug,Preclinical studies have demonstrated that Tye-1001 effectively inhibits tumor cell growth; at the molecular level, its affinity remains unaffected compared to the vehicle control.Tye-1002 is a receptor-targeted conjugate drug,Studies have shown that Tye-1002 can effectively inhibit tumor cell growth, and the drug carrier does not affect the anti-tumor activity of small molecule X3. Animal experiments are currently underway.
The market’s fervent enthusiasm for antibody-drug conjugates (ADCs) has highlighted the rise of another class of star anticancer drugs, while emerging high-potential therapeutic modalities, including peptide-drug conjugates (PDCs), also herald a new dawn for the future of healthcare.
Embracing innovation and supporting the establishment of cutting-edge technologies in China is an inevitable path for the domestic pharmaceutical industry to go global. We look forward to overseas-returnee elite entrepreneurial teams like Taierkang Biotechnology establishing their foothold in China while keeping a global perspective, delivering safer, more effective, and more affordable high-quality new drugs to patients worldwide.