Balancing Strong Innovation and Steady Growth: Grand Pharmaceutical's Strategic Blueprint

The pace of development and industrial landscape of China’s pharmaceutical industry are undergoing profound changes, with internationalization and innovation becoming the prevailing themes for pharmaceutical enterprises today.

Recently, Grand Pharmaceutical (0512.HK), a Hong Kong-listed, innovation-driven pharmaceutical company, has consecutively announced breakthrough progress in multiple innovative products across its business segments in cardiovascular and cerebrovascular emergency care, respiratory and critical care anti-infectives, and ophthalmology, drawing significant attention from the industry.

VCBeat’s research reveals that, in fact, over the past six months, Grand Pharmaceutical Group Limited has weathered the “headwinds” of the broader macroeconomic environment and achieved frequent breakthroughs in its innovative explorations across technologies, products, and therapeutic areas.

According to recent public information from Grand Pharmaceutical Group Limited, the company continues to launch source-innovative products and pipelines in its long-established fields—including cardiovascular and cerebrovascular emergency care, respiratory and critical care anti-infectives, and ophthalmology—and has achieved breakthrough progress.

The company's Jext for the treatment of severe allergic reactions^®Pre-filled Epinephrine Auto-Injector Pen Recently Approved in the Greater Bay Area, Filling a Gap in the Domestic Market,It provides an innovative and effective self-rescue method for patients in China with a history of severe allergies. The product has previously been approved and launched in 21 countries and regions, including Spain, the United Kingdom, France, Germany, and South Korea. With over 10 years of global market presence, its safety and efficacy have been thoroughly validated.

It is reported that intramuscular epinephrine administration is currently the internationally recognized first-line treatment for severe allergic reactions.Multiple domestic and international guidelines and professional societies explicitly recommend that patients with a history of severe allergic reactions keep epinephrine auto-injectors on hand., to enable early self-administration of treatment. Currently, epinephrine injections used in China are primarily supplied in ampoule form, requiring patients to wait for the arrival of healthcare professionals to receive medication, which significantly delays the critical “golden hour” for treating patients with severe allergic reactions.Jext^®Pre-filled epinephrine auto-injectors fill a domestic gap in the self-, home-, or community-based management of severe allergic reactions., thereby buying valuable time for patients to undergo further systemic therapy.

If we say Jext^®The approval of the asthma combination therapy Enzhuorun is “a timely help.”^®With Enmingrun^®can be described as “adding icing on the cake.”

Endurain^®Recipient of the EU Award for Outstanding Contribution to Public Health, it has been included in the National Reimbursement Drug List this time.The Only Triple-Combination Therapy for Asthma in ChinaIt is also the first triple-combination inhalation formulation approved in China for the indication of asthma, with clear efficacy and convenient administration. Enmingrun® also features “visualized and controllable, precise inhalation, and once-daily dosing,” which can significantly improve patients’ lung function and reduce the risk of acute exacerbations. Through the continuous efforts of Grand Pharmaceutical Group Limited, two asthma products comprising three specifications have successfully passed the national medical insurance negotiations and have been officially included in the Category B list of the National Reimbursement Drug List (2022 Edition) for Basic Medical Insurance, Work-Related Injury Insurance, and Maternity Insurance.Further expanded the market coverage of the company’s products in the field of respiratory disease treatment, while providing a new treatment option for patients requiring long-term asthma management.

Meanwhile,GPN00068 (APAD), a Novel Small-Molecule Compound with a Unique Mechanism of Action Independently Developed for Critical Conditions Such as Sepsis, and are respectively used in the field of ophthalmology forTwo Innovative Products, GPN00136 (BRM421) and GPN00833 (APP13007), for the Treatment of Dry Eye Disease and Post-Ophthalmic Surgery Anti-Inflammatory and Analgesic Care, the domestic IND applications for the above three products have also been accepted by the National Medical Products Administration in recent days.

As a well-established leader in the pharmaceutical industry, Grand Pharmaceutical Group Limited has not confined its innovation to merely reworking existing territories; instead, the company’s “innovative vision” actively scans for emerging needs and new technologies within the field.

As one of Grand Pharmaceutical Group Limited’s core strategic sectors, the critical care anti-infective field has recently seen a stream of positive developments.ForSTC3141: A Globally Innovative Drug in the Field of Critical CareThe Phase Ib clinical trial for the treatment of sepsis (REFINE), conducted in Australia and Europe, has recently completed full patient enrollment and successfully administered continuous intravenous infusion to enrolled patients for 72 hours.

STC3141 is a blockbuster product independently developed by Grand Pharmaceutical Group Limited, which holds global rights to the drug. Featuring an innovative mechanism of action, STC3141 reverses organ damage caused by excessive immune responses by neutralizing extracellular histones and neutrophil extracellular traps (NETs). It is indicated for multiple critical conditions, such as sepsis and acute respiratory distress syndrome (ARDS), which are associated with high clinical mortality rates and a lack of specific therapeutic agents. STC3141 has secured patent protection in 12 countries and regions worldwide. It has obtained seven clinical trial approvals across five countries in three continents—China, Australia, Belgium, the United Kingdom, and Poland—for four indications: sepsis, ARDS, severe COVID-19 infection, and COVID-19-induced ARDS. The comprehensive advancement of its international multicenter clinical trials underscores the continuous enhancement of Grand Pharmaceutical’s global innovative R&D capabilities.

Running neck and neck with STC3141 is another modelOral Small-Molecule 3CL Protease (3-Chymotrypsin-Like Protease, 3CLpro) Inhibitor GS221 for the Treatment of SARS-CoV-2 Infection. It successfully conducted clinical studies in China, demonstrating favorable outcomes in terms of safety, tolerability, and clinical improvement.Following drug administration, patients demonstrated improved clinical symptoms, a shortened time to nucleic acid negativity, and a trend toward rapid decline in viral load.。

In other words, the two blockbuster innovative products in Grand Pharmaceutical's portfolio, GS221 and STC3141,It is expected to achieve coverage of treatment for patients with mild, moderate, and severe COVID-19.。

On the other hand,In the field of nuclear medicine, which has attracted significant capital attention and seen sustained research activity in recent years, Grand Pharmaceutical Group Limited made forward-looking strategic investments at an early stage. The company’s radiopharmaceutical oncology division has recently achieved multiple breakthroughs in Radionuclide Drug Conjugates (RDCs).

Among Grand Pharmaceutical’s extensive pipeline of radiopharmaceutical products, the Investigational New Drug (IND) applications in China for two globally innovative Radiopharmaceutical Diagnostic Complex (RDC) products—TLX591-CDx for the diagnosis of prostate cancer and TLX250-CDx for the diagnosis of clear cell renal cell carcinoma (ccRCC)—have been approved by the National Medical Products Administration (NMPA). In addition, the IND application in China for TLX101, a globally innovative RDC for the treatment of glioblastoma multiforme, has recently been accepted by the NMPA. This product has received orphan drug designation in both the United States and Europe, and its Phase I/II clinical trials underway in Europe and Australia are progressing smoothly.

Notably, following the U.S. approval and market launch of TLX591-CDx in December 2021, its sales revenue exceeded expectations. The product’s global sales revenue in the fourth quarter of 2022 reached approximately AUD 78.2 million (equivalent to RMB 368 million), representing a quarter-on-quarter increase of over 40% (Source: telixpharma.com). As Grand Pharmaceutical Group Limited continues to advance the research and development of its innovative radiopharmaceutical products, this is expected to further enhance the company’s comprehensive capabilities in the oncology diagnostic and therapeutic segment of its radiopharmaceutical business.

It is evident that Grand Pharmaceutical Group Limited is expanding its footprint in both mature and innovative technology sectors, achieving remarkable progress. With nearly a century of product accumulation and market presence, the company continues to align with clinical needs, master cutting-edge technologies, and drive continuous innovation.

How Did Grand Pharmaceutical Group Limited “Revitalize Its Strategy Step by Step”?

Over the past decade, driven by capital, technology, and theoretical advancements, the rapid development of China’s innovative drug industry has gradually exhibited a trend of “involution.”

Ahead of most industry peers, Grand Pharmaceutical Group Limited has taken the lead in achieving the phased objectives of its international expansion under its innovative business layout. To date, the company has put into operation six R&D technology platforms worldwide and established ten R&D centers in China, the United States, Belgium, Germany, Australia, and other countries. It has strategically deployed a series of globally innovative pharmaceutical and medical device products with broad market prospects, rapidly building a comprehensive international framework spanning from research to product commercialization. This has enabled the company to continuously advance its transformation toward international innovation, strengthening both its in-house R&D capabilities and its diversified product pipeline.

Balancing Independent R&D with Global Expansion, Grand Pharmaceutical Group Limited’s Commitment to Innovative Research and Development Is Evident, with Continuous Increases in Related Funding. According to the company’s publicly disclosed financial data, Grand Pharmaceutical Group Limited invested approximately HK$1.6 billion in R&D and projects in the first half of 2022.

Through persistent commitment to innovative transformation, the Company has currently accumulated a pipeline of 114 projects under development, among which 46 (approximately 40%) are innovative projects. These projects span various stages from preclinical development to New Drug Application (NDA) submission, featuring a well-structured portfolio that has established a robust tiered effect.

Overview of Grand Pharmaceutical’s Innovative Projects Under Development (Data Source: Grand Pharmaceutical 2022 Interim Report)

In the pharmaceutical technology sector, Grand Pharmaceutical Group Limited has cultivated deep expertise for many years in ophthalmology, respiratory and critical care anti-infectives, and emergency cardiovascular and cerebrovascular treatments. Among these, asOne of China's leading integrated enterprises in the research and development, manufacturing, and sales of ophthalmic pharmaceuticals, the company’s ophthalmology division currently offers more than 30 products on the market and has six innovative projects under development. Its product portfolio covers both the anterior segment and the fundus, primarily focusing on mainstream indications such as dry eye disease, retinal hemorrhage, glaucoma, cataracts, inflammation, and myopia-related conditions. The offerings span several categories, including prescription drugs, over-the-counter (OTC) medications, medical devices, and consumer health products, andBuilt a "Public Eye Care Ecosystem" integrating "prevention + treatment + wellness"。

In another strategic sector of competitive advantage—Respiratory and Critical Care Anti-Infective TherapyGrand Pharmaceutical Group Limited currently has nearly 10 marketed products, covering multiple indications such as rhinitis, pharyngitis, bronchitis, pneumonia, and asthma, thereby establishing a relatively comprehensive product portfolio in the field of respiratory disease treatment. Meanwhile, this business segment also boasts several innovative products under development, targeting conditions including allergic rhinitis, sepsis, acute respiratory distress syndrome (ARDS), parainfluenza, and COVID-19 infection. The company adheres to the R&D philosophy of independent innovation and global expansion in the respiratory and critical care anti-infective sector, continuouslyBuild a product cluster for full-cycle management of chronic airway diseases and a pipeline of critical-care anti-infective productsto consolidate its industry position.

Emergency Care for Cardiovascular and Cerebrovascular ConditionsAlso belonging to Grand Pharmaceutical Group Limited's advantageous business segments, the companyLayout and develop urgently needed emergency clinical products around three major emergency scenarios: in-hospital emergency care, pre-hospital emergency care, and community-based emergency care., recognized as a “National Base for the Production of Essential Medicines,” a “National Strategic Reserve Manufacturer of Emergency Medications,” and a “Construction Unit of the National Centralized Production Base for Small-Variety (Shortage) Drugs.” In this segment, it holds a portfolio of 24 drug products, among which 14 are included in the National List of Emergency and Critical Care Medicines and 16 are listed in the National List of Shortage Drugs. Meanwhile, the company has more than 20 products in its R&D pipeline, ranking among the industry’s largest in terms of product pipeline size.

In the field of nuclear medicine, which has attracted significant market attention recently, technological barriers are relatively high, and it is also a sector where Grand Pharmaceutical Group Limited has made substantial investments.

By leveraging its precise strategic layout for international leading technologies and its capability to introduce, digest, and absorb such technologies, Grand Pharmaceutical Group Limited has currently reserved 13 globally innovative products in the field of radiopharmaceuticals for oncology diagnosis and treatment (with IND applications for three of these products having been accepted by the National Medical Products Administration). These products cover six radionuclides and eight types of cancer. Meanwhile, the company has achieved comprehensive coverage across multiple segments in this field, including R&D, manufacturing, sales, and regulatory qualifications, thereby establishing a complete industrial chain. Centered on the therapeutic concept of "integrated oncology diagnosis and treatment," Grand Pharmaceutical Group Limited has arguablyA Global Leader in Nuclear Medicine for Oncology Diagnosis and Treatment。

It is worth mentioning that the company’s blockbuster innovative product, Yttrium [90Y] Microspheres for Injection (EaganTai^®) provides a novel and effective treatment option for patients with primary liver cancer in China,Marking the advent of a new internationalized, precision interventional therapy regimen for liver malignancies in China。

It is reported that Yigantai^®Following its official launch in China in May 2022,Over 50 hospitals have completed the procedures for radionuclide transfer, and formal surgical procedures have been launched at more than 30 hospitals across 17 provinces and municipalities in China.. Follow-up results showed that patients who received Yigantai^®The overall patient response to surgery was relatively ideal, with the majority of patients achieving favorable clinical outcomes and prolonged survival. Among all patients followed up for 3 months or longer, Yigan Tai^®The objective response rate for the treatment of malignant liver tumors exceeded 50%, with more than half of patients experiencing tumor shrinkage, among whomFive patients achieved complete symptom resolution without the need for resection; the disease control rate among followed-up patients exceeded 95%, demonstrating significant therapeutic efficacy.。

According to the announcement, Grand Pharmaceutical Group LimitedYi Gan Tai has been administered to over 300 physicians across 70 hospitals.^®Surgical theory and skills training: Nearly 20 experts have completed rigorous one-on-one training with overseas specialists., having obtained the qualifications for independent surgical procedures, with several experts on the verge of qualifying as training instructors, which will further accelerate the clinical adoption of YiGanTai® radioactive interventional procedures.

With the adjustment of China's epidemic prevention and control policies, consult Yigan Tai^®The proportion of patients receiving treatment in outpatient settings has increased significantly, with many hospitals successively establishing specialized Yigan Tai clinics.^®Outpatient services are designed to meet patients' clinical needs,Yi Gan Tai^®It is also poised to enter a period of explosive market growth, further solidifying the company’s position as a global leader in the field of radiopharmaceuticals for oncology diagnosis and therapy.。

The nuclear medicine platform for oncology diagnosis and therapy is a high-end technical platform that Grand Pharmaceutical Group Limited has prioritized in the field of oncology,The company is currently advancing the construction of its Class A radionuclide production platform in an orderly manner.. In the future, the Company will continue to strengthen R&D and investment in its radiopharmaceutical oncology diagnosis and treatment segment, enriching and refining its product pipeline and industrial layout,Strive to advance 10 radiopharmaceutical products into clinical stages within the next three years, and establish a pipeline portfolio of more than 25 radiopharmaceutical products for oncology diagnosis and therapy., forming a cluster of radiopharmaceutical products for tumor diagnosis and treatment centered on the Yttrium [90Y] Microspheres Injection (Yi Gan Tai®).

From a holistic perspective, among the numerous business segments laid out by Grand Pharmaceutical Group Limited, each reflects the “dual-wheel drive” model of “independent R&D + global expansion,” whether based on its established industry position in these fields or on its accumulation of domestic and international R&D resources.Grand Pharmaceutical Group Limited’s strategic layout has successfully positioned the company in a virtuous cycle of multi-dimensional synergy across product development, innovation, revenue generation, and internationalization.

From asthma inhalation formulations to polypeptide eye drops, and further to yttrium-90 (90Y) microsphere injections, Grand Pharmaceutical Group Limited is pursuing breakthroughs across multiple areas of strength. Its innovative products have achieved phased breakthroughs, yet the company will subsequently face greater risk costs and financial pressure. For the company, is this a mixed blessing, or was it well-prepared?

(Image source: Grand Pharmaceutical 2021 Annual Report)

The answer can be found in Grand Pharmaceutical Group Limited’s financial reports in recent years. Since 2017, the company has maintained strong growth in commercial revenue, achieving an exceptionally high compound annual growth rate (CAGR) of approximately 16% over the past five years. Moreover, its net profit growth has been even more remarkable, with a more than five-fold increase from 2017 to 2021, representing an average CAGR exceeding 51%.

Against the backdrop of sustained investment in innovative R&D, the Group’s revenue has continued to rise, thereby validating that the Company’s pursuit of innovation is firmly grounded in its own steady growth.

The “Outline of the ‘Healthy China 2030’ Plan” clearly states that health is an essential requirement for promoting all-round human development, a fundamental condition for economic and social development, an important indicator of national prosperity and strength, and a common aspiration of the general public. To this end, we need to deepen healthcare system reforms, accelerate the development of the health workforce, and promote technological innovation in the health sector.

The “14th Five-Year Plan for Bioeconomy Development” issued by the General Office of the State Council points out that we should accelerate the research, development, and industrialization of drugs for the treatment of major clinical diseases, and support the R&D of high-quality generic drugs. The “14th Five-Year Plan for Pharmaceutical Industry Development” released by nine departments including the National Development and Reform Commission emphasizes strengthening breakthroughs in key core technologies, vigorously promoting the R&D of innovative products, and improving the level of industrialization technology. It also aims to promote the industrialization and application of innovative drugs, accelerate the industrialization process of new products, and facilitate the promotion and application of innovative products.

Furthermore, the China Atomic Energy Authority, in conjunction with the National Health Commission and seven other departments, previously issued the Medium- and Long-Term Development Plan for Medical Isotopes (2021–2035). The plan explicitly states that, taking the eight most commonly used isotopes in nuclear medicine as examples, annual demand is conservatively projected to grow at a rate of 5%–30%. This is China’s first programmatic document specifically addressing the application of nuclear technology in healthcare, and it holds significant importance for enhancing the capabilities of the medical isotope-related industry and ensuring the implementation of the Healthy China strategy.

In light of the development trends in China’s pharmaceutical industry and the active support from various policy initiatives, Grand Pharmaceutical Group Limited has stated that it will firmly adhere to its development philosophy of “leveraging comprehensive advantages, driving innovation, and expanding globally.” The company is committed to actively implementing its strategic development plans to achieve sustained and steady growth across all aspects of its business, including products, profitability, expertise, and management.

“On one hand, we must focus on the present by continuously enriching our product pipeline and optimizing our product portfolio, maintaining a rapid pace of market expansion, and achieving high-quality completion of all economic and outcome-based indicators. On the other hand, we must take a medium- to long-term view, prioritizing stable growth, ensuring steady and swift progress in innovation breakthroughs, efficient and synergistic operational management, sustainable corporate development, and consistent improvement in our industry standing."This is an excerpt from Grand Pharmaceutical Group's 2023 New Year's message.

As can be seen, after 84 years of development and accumulation, Grand Pharmaceutical Group Limited has successfully forged ahead amidst the rapid transformations in China’s pharmaceutical industry and quickly secured a leading position.

Leveraging its robust capabilities, commitment to fundamental technological innovation, alignment with national development strategies, and responsiveness to global expansion trends, Grand Pharmaceutical Group Limited fulfills its corporate social responsibility through concrete actions. By continuously harnessing its comprehensive competitive advantages and driving innovation, the company is advancing a new paradigm for the sustainable development of “Healthy China.” Grand Pharmaceutical is steadily evolving into a respected, technology-driven international pharmaceutical enterprise that gives back to society and earns the trust of physicians and patients alike.