Lunan Bio's New Radiopharmaceutical Lu-177-LNC1008 Receives IND Acceptance for Solid Tumors

On February 19, according to the official website of the Center for Drug Evaluation (CDE), the Class I radiopharmaceutical therapeutic drug developed by Yantai Lannacheng Biotechnology Co., Ltd. (hereinafter referred to as “Lannacheng”)¹⁷⁷The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has publicly accepted the clinical trial application for Lu-LNC1008 Injection. According to Lannacheng’s official website, this product is indicated for solid tumors, with its target not yet disclosed.

In fact,¹⁷⁷Lu-LNC1008 injection is the third radiopharmaceutical therapeutic agent that Lannacheng has submitted for clinical trial approval in China since its inception.In September last year, the Class I radiopharmaceutical therapeutic drug developed by Lannacheng¹⁷⁷Lu-LNC1003 Injection,¹⁷⁷The clinical trial applications for Lu-LNC1004 Injection have been successively accepted and publicly disclosed by the Center for Drug Evaluation of the National Medical Products Administration. The former received standard approval from the FDA on April 28, 2023, regarding¹⁷⁷The Notice of Approval for Clinical Trial of Lu-LNC1003 Injection (Study May Proceed Letter), the latter of which also received the SMP approved and issued by the FDA on January 6, 2023.

Lanacheng, established in 2021 and headquartered in the picturesque coastal city of Yantai, with a subsidiary set up in Singapore. As an emerging player, Lanacheng has been able to rapidly achieve success in the high-barrier, capital-intensive radiopharmaceutical sector, thanks to the support of its team behind it.

As the saying goes, “It’s good to have a big tree to lean on for shade.” Lan Nacheng has two such “big trees” behind him: Dongcheng Pharmaceutical Group (DC PHARMA), one of China’s leading enterprises in nuclear medicine, and Professor Chen Xiaoyuan, an internationally renowned expert in molecular imaging and nanomedicine.

“DC PHARMA,” one of the industry’s leading players, has been strategically positioned in the nuclear medicine sector for a decade since 2014, with subsidiaries or branches established in dozens of cities across China. In recent years, DC PHARMA acquired Chengdu Yunke Pharmaceutical, Shanghai Yitai Pharmaceutical, and GMS (China), thereby achieving comprehensive coverage of the entire industry chain from diagnostic to therapeutic radiopharmaceuticals. In 2017, DC PHARMA acquired 100% equity interest in Nanjing Andike Positron Research & Development Co., Ltd., further strengthening its footprint in the radiopharmaceutical field and establishing itself as an enterprise capable of providing holistic nuclear medicine solutions in the Chinese market.

DC PHARMA, through multiple acquisitions, jointly holds a leading position in China's radiopharmaceutical industry alongside China Isotope & Radiation Corporation.DC PHARMA, originally focused on the production of active pharmaceutical ingredients (APIs), has now invested over RMB 3 billion in the radiopharmaceutical sector, establishing a comprehensive portfolio that covers diagnostic radiopharmaceuticals, therapeutic radiopharmaceuticals, and nuclear pharmacies, thereby capturing half of the radiopharmaceutical market. China Isotope & Radiation Corporation (CIRC), another domestic leader in radiopharmaceuticals backed by the China National Nuclear Corporation (CNNC), has acquired several companies in recent years, including Ningbo Jun’an Pharmaceutical; however, the financial contributions from these acquisitions have not been particularly significant.

Currently, DC PHARMA has initially established five major platforms: a stable radionuclide supply platform, a drug incubation platform, a translational service platform, a production and distribution platform, and a theranostics marketing platform. It has basically completed the full industrial chain layout of nuclear medicine, covering raw material supply, R&D, clinical translation, production, and sales, thereby building a complete nuclear medicine ecosystem. Lannacheng is an important component of DC PHARMA’s nuclear medicine ecosystem.

In addition to its backing by industry leader DC PHARMA, Lanacheng’s other “secret weapon” is Professor Chen Xiaoyuan. Professor Chen’s research primarily focuses on in vitro diagnostics, in vivo imaging, nanocarriers for genes/drugs, and theranostics. Leveraging this powerful collaboration, Lanacheng has developed multiple targeted radiopharmaceuticals featuring “albumin-binding Evans blue modification,” based on its proprietary Evans blue nanoparticle technology and holding global independent intellectual property rights. Compared with conventional small molecules and peptide analogs, these agents demonstrate superior tumor retention time and higher tumor-absorbed doses, thereby offering greater advantages for radionuclide-targeted therapy.

Leveraging its robust backing, Lanacheng invested RMB 102 million in 2023 to construct a large-scale integrated laboratory spanning nearly 6,500 square meters at the “Yantai Blue Medicine Valley.” This facility integrates targeted drug synthesis, radiolabeling, preclinical cellular and animal studies, and molecular imaging, thereby accelerating the R&D of Lanacheng’s innovative radiopharmaceuticals. Currently, Lanacheng has established a relatively comprehensive pipeline for radionuclide diagnostics and therapeutics. Its targeted drugs encompass small molecules, peptides, and antibodies, with products addressing multiple indications including prostate cancer, solid tumors, glioma, and neuroendocrine tumors.

In addition, Lannacheng has collaborated with numerous renowned domestic and international medical institutions, including the German ICPO and RPO, National University of Singapore (NUS), Peking Union Medical College Hospital, Cancer Hospital Chinese Academy of Medical Sciences, Beijing Cancer Hospital, Fudan University Shanghai Cancer Center, Xijing Hospital, The First Affiliated Hospital of Zhejiang University School of Medicine, The Affiliated Hospital of Fujian Medical University, and The Affiliated Hospital of Xiamen University, to conduct multiple formal clinical trials and investigator-initiated trials.

Maintaining close ties with the entire industry chain encompassing “production,” “academia,” and “research” may well be a key reason why Lannacheng, as an emerging player, has been able to overtake competitors on the curve.

Not only is Lannacheng, a startup in the radiopharmaceutical sector, experiencing rapid growth, but the entire radiopharmaceutical market is also free from a capital winter!

With the rollout of landmark policies such as the Medium- and Long-Term Development Plan for Medical Isotopes (2021–2035) and the Technical Guidelines for Clinical Evaluation of Radiopharmaceuticals for Internal Use, along with the approval of the radiopharmaceuticals Lutathera and Pluvicto, this niche sector—once constrained by multiple bottlenecks and characterized by uneven development—is now experiencing a vibrant resurgence, entering a fast-growth trajectory even amid broader industry headwinds.Previously, IPO-bound companies such as DC PHARMA, Grand Pharma, and China Isotope & Radiation Corporation expanded rapidly; now, industry frontrunners including Lannacheng, Grand Pharma, Nuoyu Pharmaceutical, Xiantong Pharmaceutical, Fulian Pharmaceutical, and Hexin Pharmaceutical have joined the fray.

According to data from VCBeat, nuclear medicine was the subsector with the highest proportion of financing rounds exceeding RMB 100 million in the innovative drug field in 2022. Additionally, data from Grand View Research indicates that the global market size for nuclear medicine was USD 8.1 billion in 2021 and is projected to grow at a compound annual growth rate (CAGR) of 13% from 2022 to 2030. The market size was approximately USD 8.9 billion in 2020 and is estimated to reach USD 24 billion by 2030. Among these, the Asia-Pacific region is the primary growth driver for the global nuclear medicine market, with China’s nuclear medicine market reaching RMB 5 billion in 2021.

Overall, there is little disparity between domestic and overseas nuclear medicine drugs in terms of R&D.However, China lags behind Europe and the United States in the approval of innovative radiopharmaceuticals. The FDA has approved multiple innovative therapeutic radiopharmaceuticals, moving faster in the RDC (Radionuclide Drug Conjugate) sector. In recent years, the United States has seen strong momentum in the development of therapeutic radiopharmaceuticals. Bayer’s Xofigo received FDA approval in 2013; Novartis’s Lutathera was approved by the FDA in 2018 for the treatment of patients with SSTR-positive gastroenteropancreatic neuroendocrine tumors; and Pluvicto gained FDA approval in March 2022 for the treatment of patients with metastatic castration-resistant prostate cancer. RDC drugs represented by Lutathera and Pluvicto have further boosted industry confidence in radiopharmaceuticals, accelerating the market’s shift from diagnostic to therapeutic radiopharmaceuticals.

From a detailed perspective, in terms of radionuclides, lutetium [¹⁷⁷Lu]-labeled drugs are currently one of the mainstream radiopharmaceuticals under development. The three radioactive therapeutic drugs previously submitted for clinical trials by Lannacheng contain the radionuclide lutetium [¹⁷⁷Lu]。Lutetium[¹⁷⁷Lu] is a therapeutic radionuclide. Due to the relatively low energy of its beta particles, with an average tissue range of 670 μm, it causes mild bone marrow suppression during irradiation of lesions, making it safer than other therapeutic radionuclides. Clinical trials abroad have shown that lutetium [¹⁷⁷[Lutetium]-labeled multiple drugs have unique advantages in tumor therapy, especially suitable for the elimination of small-volume tumors and metastases.

Currently, lutetium [¹⁷⁷Lu] The value of lutetium in the treatment of prostate cancer and neuroendocrine tumors has been validated. Currently, the majority of investigational pipelines in the industry remain focused on prostate cancer and neuroendocrine tumors, while a small number are exploring lutetium[¹⁷⁷Lu]-labeled drugs in more indications such as renal cell carcinoma and colorectal cancer, as well as lutetium [¹⁷⁷Lu]-labeled drugs in combination with small-molecule drugs.

In addition to lutetium [¹⁷⁷Lu] In addition to being a popular biomarker, fluoro[¹⁸F] Gallium [⁶⁸Ga], Yttrium [⁹⁰Y], Zirconium [⁸⁹The R&D enthusiasm for markers such as Zr] is also extremely high. Furthermore, in terms of targets and indications, many domestic radiopharmaceutical pipelines are developing generic or improved novel drugs benchmarked against Novartis’s two approved products. PSMA and SSTR have become hot targets in radiopharmaceutical development, with numerous pipelines focused on prostate cancer and neuroendocrine tumors. Preliminary signs of homogenization have already emerged, a trend that warrants attention and vigilance.

The expansion of the radiopharmaceutical industry hinges on breakthroughs in novel targets, new molecules, new indications, and new radionuclides. Alongside the explosive growth of the radiopharmaceutical sector, a certain degree of pipeline homogenization has inevitably emerged. Currently, apart from local administration and hematologic malignancy treatments, there are only two successful cases of therapeutic radiopharmaceuticals in the field of solid tumors, with numerous R&D challenges yet to be addressed. These include determining which tumors are suitable for radiopharmaceutical therapy, assessing whether peptides, antibodies, or small molecules hold greater potential, overcoming key issues such as insufficient targeting molecules and renal clearance associated with peptide-based radiopharmaceuticals, and addressing challenges related to the large molecular weight, slow tissue penetration, and excessively long half-life of antibody-based agents.

Next, the industry needs to create more successful cases of radiopharmaceuticals across a broader range of tumor types, molecular subtypes, and therapeutic targets.

Reference: VCBeat’s “White Paper on the Radiopharmaceutical Industry: Mapping Nearly 7,000 Global Pipelines and Competing in Target, Ligand, and Radionuclide Innovation”