Published Time：

Since the launch of the reform of the drug review and approval system, driven by multiple factors such as policy guidance, increased R&D investment, technological advancements, capital support, and the return of talent, China's innovative drug industry has experienced explosive growth. During this period, traditional pharmaceutical companies have undergone transformations, emerging Biotech companies have grown significantly, and domestic innovative drug R&D has yielded fruitful results.

As one of the leading pharmaceutical companies in China, HealthGen has continuously increased its R&D investment in recent years, focusing on innovative drugs and high-barrier complex formulations. In 2022, HealthGen invested 1.742 billion yuan in R&D, accumulating over 5.1 billion yuan in the past four years, with its R&D expense ratio reaching 10.16%. Driven by innovation and high-barrier technology platforms, HealthGen has become a comprehensive pharmaceutical group focused on innovative research. The group owns two large listed companies: HealthGen and Lizhu Group. The group has established a rich pipeline layout in areas with significant clinical needs, including respiratory, digestive, assisted reproduction, psychoneurology, oncology, anti-infection, and metabolic diseases, forming a diverse product matrix and a pipeline of drugs under development.

Innovation is the lifeline of an enterprise. In recent years, HealthGen has broken down barriers in R&D, approval, and production. With multiple high-quality inhaled formulations such as "Shutanlin," "Lishutu," and "Wushu," it has gradually overcome development bottlenecks in its niche industry, becoming a leading company in the respiratory treatment field that has broken the overseas monopoly. It has successfully achieved coverage of the main categories of asthma and COPD inhaled treatment drugs in existing and under-development products, and has rapidly opened up and covered the domestic market through opportunities such as national negotiations and centralized procurement, becoming a leader in high-end complex formulations in China.

In addition to independent R&D, HealthGen continuously pays attention to cutting-edge technologies and strengthens external cooperation. Through various methods such as authorized introduction and collaborative development, it actively seeks products in the company's advantageous areas. This year, the company has successively introduced new drugs such as the influenza drug TG-1000, expanding into other respiratory diseases and consolidating its leading position in the respiratory field. The company will also improve the construction of its core product team to achieve long-term sustainable development.

Furthermore, HealthGen has made extensive layouts in the fields of medicine and medical innovation, including AI+medicine, gene drugs, cell therapy, small molecule pharmaceuticals, and large molecule pharmaceuticals, all of which are at the forefront of global medical and health innovation. By participating in investments in leading domestic and international innovative enterprises in various sub-sectors, it can not only share in the growth dividends of global medical and health innovation but also enable Chinese pharmaceutical companies to quickly integrate into the global cutting-edge innovation system.

AI+Pharmaceutical Medicine Catches Industry Tailwind

The popularity of generative AI, with ChatGPT at its core, has once again drawn global attention to artificial intelligence. According to CITIC Securities' prediction, AI will bring revolutionary changes to various fields, including the pharmaceutical industry.

According to a report by Global Market Insights, the global medical AI market size exceeded US$50 billion in 2022 and is expected to grow at a compound annual growth rate of over 29% to reach US$70 billion by 2032. In terms of market structure, drug discovery and medical imaging are the two areas with the widest AI applications, accounting for over 50% of the total. With the development of the pharmaceutical industry and the iteration of AI technology, the AI drug R&D market size is expected to exceed US$20.5 billion by 2032.

Public information shows that HealthGen has been involved in the application field of AI+pharmaceutical medicine for several years.

In the second quarter of this year, PharmGPT, officially released by Lizhu Group, a subsidiary of HealthGen, has gained influence and is continuously being updated. According to an interview with Pei Jianfeng, founder of InfiniAI, PharmGPT was jointly developed by InfiniAI and Peking University and is the first GPT system in the Chinese pharmaceutical field. This GPT system stabilizes the drug development success rate at over 20%, a world-leading rate, and is the most core and proudest achievement of InfiniAI.

In addition to AI drug development, HealthGen's invested companies have also achieved significant results in AI diagnosis.

On May 23 this year, LungLife AI (AIM: LLAI.L), an invested company, announced that its LungLB® prospective key validation study had completed patient recruitment, with a total of 425 participants successfully enrolled from 17 clinical trial centers in the United States. Positive results from the LungLB® prospective clinical study were published. On June 6 this year, LungLife AI published the results of the LungLB® prospective clinical trial in BMC Pulmonary Medicine. The results showed that the blood-based LungLB® performed exceptionally well in diagnosing patients with indeterminate pulmonary nodules.

On June 18 this year, the national information security level protection 2.0 third-level certification, the most authoritative information product security level qualification certification in China, was successfully obtained by the wholly-owned subsidiary ShengAo Yunzhi of Zhuhai Saint-M Bio-diagnostic Technology Co., Ltd. ("Saint-M Bio"), an invested company, for its "Lung Cancer Early Diagnosis Digital Health Management System." In the comprehensive lung cancer early diagnosis solution provided by ShengAo Yunzhi, the lung cancer early diagnosis digital health management system covers the information security of the entire diagnosis and treatment process, including CT image analysis, microscopic cell analysis, transmission and storage, and patient health management modules.

Participating in Global Gene Drug Giants

Beam Therapeutics (BEAM.NASDAQ), a gene therapy giant in which Lizhu Group, a subsidiary of HealthGen, holds shares, was founded in 2017. It is committed to creating a new class of precision gene drugs through its proprietary single-base editing technology, with a vision of providing lifelong cures for patients with serious diseases. In February 2020, Beam successfully listed on the Nasdaq.

In May this year, Beam announced progress in its pipeline in hematology, immuno-oncology, and genetics.

In the field of hematology, BEAM-101, a patient-specific autologous hematopoietic stem cell therapy, aims to potentially alleviate the effects of β-thalassemia or sickle cell disease by increasing fetal hemoglobin. Its Phase I/II clinical trial is currently underway at five clinical trial centers, with plans to start expanding the cohort enrollment this year and publish preliminary data from the BEACON trial in 2024.

In the field of immuno-oncology, BEAM-201 is an allogeneic CAR-T cell therapy. Its Phase I/II clinical trial for treating relapsed/refractory T-ALL/T-LL has been initiated, with plans to start recruiting participants and complete the first patient dosing in mid-2023.

In the field of genetics, BEAM-301 and BEAM-302 are both liver-targeted lipid nanoparticle (LNP) formulations, currently in the IND application preparation stage, with plans to submit IND applications in late 2023/early 2024.

Following the Most Cutting-Edge Cell Therapy

Global research on CAR-M therapy started relatively late, first appearing publicly in March 2020. To date, no more than 10 companies globally have disclosed their involvement in CAR-M therapy. Carisma Therapeutics (Carisma), an invested company of Lizhu Group, a subsidiary of HealthGen, is one of the leading pioneers in this cutting-edge field of cell therapy.

On March 18, 2021, Carisma announced the completion of the first patient dosing for its CAR-M therapy, CT-0508, a CAR-M cell therapy targeting HER2 solid tumors. Carisma officially claimed that this is the world's first application of engineered macrophages in clinical research, making this clinical trial a key milestone in the development of gene therapy.

On May 11 this year, Carisma announced the progress of its R&D pipeline in the first quarter of 2023. CT-0508 is currently in Phase I clinical trials; in addition, Phase Ib clinical trials of CT-0508 have been initiated to study the efficacy and safety of CT-0508 combined with Merck's KEYTRUDA® in the treatment of HER2-overexpressing cancers. Partial data is expected in the second half of 2023. The production technology of CT-0508 has been transferred to Novartis, including the initial production for clinical trial patients.

In addition to foreign cell therapy giants, Yi Zun Bio, an investor, was listed on the 2023 Hangzhou Quasi-Unicorn Enterprise List.

On May 25 this year, the initiation meeting for the IIT clinical research project, "A clinical study to evaluate the safety, tolerability, preliminary efficacy, pharmacokinetics, and immunogenicity of the universal CNK-UT cell injection for treating patients with advanced solid tumors (CNK-UT-IIT202201)", jointly applied for by Yi Zun Bio, was successfully held at the First Affiliated Hospital of Zhejiang University School of Medicine.

Yi Zun Bio officially claims that the CNK-UT cell drug can kill various tumor cells, including colorectal cancer, breast cancer, lung cancer, and kidney cancer. Yi Zun Bio's IIT clinical research project at Shulan Hospital has administered the first dose to a patient with advanced liver cancer and completed the observation of the minimum dose safety period, confirming the safety of this dose and also observing positive hematological changes, officially entering the second dose exploration and clinical re-infusion phase.

Sharing the spoils Small molecule Trillion-dollar market for targeted drugs

In the pharmaceutical field, small molecule innovative drugs are the current mainstay of drug development. In 2021, the global market size of small molecule innovative drugs was approximately US$180 billion. Frost & Sullivan's data shows that the Chinese market for small molecule tumor-targeted therapies has increased from 8.5 billion yuan in 2016 to 37.5 billion yuan in 2020, and is expected to reach 120.5 billion yuan in 2025 and 207 billion yuan in 2030.

On April 27 this year, Elicio Therapeutics (ELTX.NASDAQ), in which Lizhu Group, a subsidiary of Healthyuan Holdings, invested, announced that the first patient had been dosed in the Phase I/II clinical trial of ELI-002 7P. ELI-002 7P is a 7-peptide formulation of the investigational therapeutic cancer vaccine ELI-002 for the treatment of tumors driven by seven KRAS mutations (approximately 25% of solid tumors). On June 1 this year, Elicio announced the completion of its merger with Angion Biomedica Corp., enabling it to list on the Nasdaq.

The leading product of the invested company, Xin Yuan, ABP-671, is an oral small molecule URAT1 inhibitor for the treatment of chronic gout. In two recent Phase IIa trials, ABP-671 showed good tolerability and reduced uric acid levels below the hyperuricemia threshold. Xin Yuan has met with the US FDA and is expected to enter Phase IIb/III clinical trials soon.

The invested company, Shanghai Kentaibio Pharmaceutical Co., Ltd. (Kentaibio), focuses on the development of new-generation kinase inhibitor drugs, with its R&D strategy focusing on untargeted kinases, clinical drug resistance mutations, and non-catalytic function regulation of kinases. The company was founded by Dr. Ma Dawei, an academician of the Chinese Academy of Sciences. It has established a kinase inhibitor design and synthesis platform, a multi-dimensional kinase screening platform, a chemical proteomics target discovery and verification platform, and a kinase non-catalytic function discovery and regulation technology platform.

Large molecule innovative drugs Global synchronization

Large molecule drugs have advantages such as good solubility, better specificity, and fewer adverse reactions, and are used in a wider range of treatments, including the nervous system, cardiovascular system, metabolic and immune systems, tumors, and infectious diseases. According to market research reports, market demand will continue to grow, with the market size expected to reach over US$30 billion in 2023.

On May 8 this year, Beijing Luzhu Biotechnology Co., Ltd. (Luzhu Bio, stock code: 2480.HK), in which Lizhu Group, a subsidiary of Healthyuan Holdings, invested, was officially listed on the main board of the Hong Kong Stock Exchange, completing its initial public offering. As the first shingles vaccine stock in Hong Kong, the company's listing on the Hong Kong capital market is of great significance for promoting product R&D and international development.

Established in 2001, Luzhu Bio focuses on the R&D of vaccines and antibody drugs. Its core product, the shingles vaccine LZ901, is the only domestically produced vaccine in the world that has been submitted for clinical trials in both China and the United States, and is also the second domestically produced vaccine to apply for clinical approval from the US FDA. In addition, the company also has two clinical-stage products, including an adalimumab biosimilar and a bispecific antibody drug for the treatment of B-cell lymphoma and leukemia, as well as four pre-clinical products, with a rich and diverse R&D pipeline.

On June 6 this year, two products, LB1410 and LB4330, from Shanghai Jinsin Biopharmaceutical Technology Co., Ltd. (Jinsin Bio), an invested company, were selected for poster presentations at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting. LB1410 is the first clinical pipeline molecule independently developed by Jinsin Bio based on the Sbody platform, the first PD1/TIM3 bispecific antibody in China to enter clinical trials, and the second product globally with the same target. LB4330 is the world's first dual-functional immunotherapy product targeting tumor CD8+ T cells and CLDN18.2, used for the treatment of CLDN18.2-positive pancreatic cancer, gastric cancer, and ovarian cancer, and is expected to be extended to broad-spectrum solid tumors that are CLDN18.2-negative.

New medical materials Opening up new tracks

On April 28 this year, Zhuhai Madefa Bio-Technology Co., Ltd. (Madefa), in which Lizhu Group, a subsidiary of Healthyuan Holdings, invested, announced that its first implantable PHA material, P34HB (trade name: Machnoon-II), successfully completed the filing of the main document for Class III medical device raw materials at the Center for Medical Device Evaluation (NMPA) on April 21. This means that medical device manufacturers will no longer need to repeat the biological verification of the material, greatly saving the development time of medical devices; medical-grade PHA will also achieve safe, stable, and compliant supply; it has opened up a new application track for innovative bio-medical PHA materials in China and will further promote the application of PHA in the global medical field.

At the "2022 Annual and Q1 2023 Performance Presentation" held recently, HealthGen, while interacting with investors, stated that it is continuously strengthening independent innovation and accelerating innovation and R&D progress, while also paying close attention to cutting-edge technologies, strengthening external cooperation, actively carrying out innovative business cooperation models in the global market, and actively seeking opportunities for cutting-edge technology expansion and product internationalization through various methods such as collaborative development and licensing introduction, and strengthening its commercialization and integration capabilities. Undoubtedly, with a long-term and comprehensive layout, HealthGen has already stood at the forefront of global innovation, with a bright future ahead.

Source: Jimu News