Integrated Biopharmaceutical R&D and Manufacturing Company
On July 8, 2026, the official website of the Center for Drug Evaluation (CDE) under the National Medical Products Administration published a notice regarding the application submitted by Shandong BoAn Biotechnology Co., Ltd.BA1203 InjectionThe application for clinical trial of the new drug has been officially accepted. The acceptance number is CXSL2600712, and the registration category is Class 1 therapeutic biological products.This masked PD-1/IL-2 bifunctional fusion protein represents BoAn Biotech’s strategic investment in next-generation cancer immunotherapy. Coupled with the previously announced clinical data for its CLDN18.2 ADC (BA1301), BoAn Biotech’s innovative pipeline is accelerating toward realization.The Chairman and CEO has led the company from its beginnings in biosimilars to steadily advancing into the innovative drug sector.Jiang Hua— A senior executive with 26 years of deep expertise within the Luye Pharmaceutical system, and an industry “windbreaker” dedicated to the goal of “transitioning from follower to leader.”
I. Another Class 1 New Drug IND: Accelerating the Realization of the Innovative Pipeline
Figure: CDE Official Website Public Notice of Acceptance for BA1203 InjectionThe BA1203 injection, now accepted for review, is a masked PD-1/IL-2 bifunctional fusion protein. Compared with traditional IL-2 therapy, it achieves tumor-specific enrichment through PD-1 targeting, significantly reducing systemic toxicity while enhancing efficacy, representing a promising direction for next-generation cancer immunotherapy."The core of next-generation IO therapy lies in finding a better balance between efficacy and safety." Jiang Hua stated, when discussing the strategic rationale behind BA1203, that BoAn Biotech does not blindly chase trends but instead selectively cultivates therapeutic areas with genuine differentiated advantages.Just one month ago, at the 2026 ASCO Annual Meeting, BoAn Biotech announced the latest clinical data for its independently developed CLDN18.2 ADC (BA1301). This ADC drug, equipped with the company’s proprietary C-Lock site-specific conjugation technology, demonstrated favorable safety and antitumor activity, marking BoAn Biotech’s establishment of independent technical capabilities on its ADC platform.From biosimilars to innovative antibodies, and further to cutting-edge technology platforms such as ADCs and bifunctional proteins, BoAn Biotech’s innovative pipeline is being comprehensively rolled out. All of this is underpinned by the “stepwise development” strategy spearheaded by Jiang Hua.
II. Fudan University graduate, a 26-year veteran deeply rooted in the Luye system
Figure: Jiang Hua delivers a speech at the Hong Kong stock listing ceremony of BoAn BiotechJiang Hua’s career began at Fudan University.After graduating with her bachelor’s degree, she turned down the opportunity to work in Shanghai and chose to return to Yantai to join Luye Pharma. She has remained there ever since—a tenure spanning 26 years.From an entry-level position to Vice President of Luye Pharma, Jiang Hua achieved comprehensive professional growth within the Luye system. She witnessed the entire transformation of Luye Pharma from a local pharmaceutical enterprise into an international pharmaceutical group, spearheading multiple cross-border mergers and acquisitions and overseas market expansion, thereby accumulating extensive experience in industrial operations and globalization.Throughout her academic journey, she has never ceased to advance: holding a Master’s degree from KEDGE Business School in France and a Doctorate from the United Business Schools in Belgium. Her experience of pursuing advanced studies while working has enabled her to develop composite competencies that combine industrial insights with managerial vision."Only through continuous learning can one’s career blossom and endure," said Jiang Hua in an interview with Qilu Evening News. In the male-dominated biopharmaceutical industry, this female executive has carved out her own path with solid performance and a clear strategic vision.She has successively receivedShandong Province March 8th Red Banner Holder、Outstanding Entrepreneur of Yantai Cityamong other honors, and was elected as a member of the Yantai Municipal Committee of the Chinese People's Political Consultative Conference (CPPCC), becoming one of the representative figures in Yantai's biomedical industry.
III. BoAn Biotech: Starting with Biosimilars, Steadily Advancing toward Innovation
Figure: BoAn Biotech’s Intelligent Manufacturing Base in YantaiThe story of BoAn Biotech dates back to 2013. The company was initially founded by Dr. Dou Changlin and his technical team, focusing on the research and development of antibody-based therapeutics. In 2019, Luye Pharma completed its acquisition of BoAn Biotech, and Jiang Hua, a senior executive from the Luye Pharma system, was appointed as Chairman and CEO.A strong technical foundation paired with professional management has provided BoAn Biotech with a clear development path.Jiang Hua proposedA Stepped Development Strategy: “Starting with Biosimilars, Progressing Confidently Toward Innovation”
Step 1: Rapidly commercialize biosimilars to accumulate cash flow and build industrialization capabilities
Step 2: Gradually deploy cutting-edge technologies such as innovative antibodies and ADCs to build long-term competitiveness
Step 3: Building an international biopharmaceutical company for the global market
"Diversified innovation, selectively cultivating competitive advantages." This is the business philosophy that Jiang Hua has repeatedly emphasized. In her view, innovation is not about blind expansion, but rather about leveraging one's own capabilities to deeply explore and excel in areas of strength.This strategy soon yielded results. In 2021, BoAn Biotech’sDenosumab Injection (Boyoubai®) Approved for Market Launch, Becoming the World’s First Denosumab Biosimilar, achieving a breakthrough as the "world's first generic version." Subsequently, products such as bevacizumab (Boyounuo®) were also approved and launched in succession.In just a few years, BoAn Biotech has grown from an R&D-focused company into a commercial biopharmaceutical enterprise with annual revenues reaching hundreds of millions of yuan, with its product portfolio covering four major therapeutic areas: oncology, autoimmune diseases, ophthalmology, and metabolism.
IV. Listing on the Hong Kong Stock Exchange: Capital Fuels Accelerated Globalization
Figure: BoAn Biotech Listed on the Main Board of the Hong Kong Stock Exchange in December 2022On December 30, 2022, BoAn Biotech was officially listed on the Main Board of the Hong Kong Stock Exchange (Stock Code:6955.HK)。Standing on the stage at the listing ceremony, Jiang Hua delivered a pragmatic and resolute speech: “Today’s listing marks another new starting point in the development journey of BoAn Biotech. Reflecting on the original aspiration behind the establishment of BoAn Biotech, we are not only rooted in China but also committed to becoming a ‘globally leading biopharmaceutical company.’”The listing has provided BoAn Biotech with more abundant financial resources and accelerated its globalization pace. Under the promotion of Jiang Hua, multiple products of BoAn Biotech are simultaneously advancing clinical development in multiple regions including China, the United States, Europe, and Japan.Among these, the development of denosumab in Japan is particularly noteworthy. This isThe Only Chinese Biosimilar Project Involving Japanese Companies in International Multicenter Clinical Trials, paving a viable path for Chinese biologics to enter the Japanese market.“Internationalization is not achieved overnight; it requires the compounding effect of experience.” In June 2026, while sharing BoAn Biotech’s overseas expansion experiences at an industry forum, Jiang Hua pointed out that Chinese innovative drugs are transitioning from “one-off transactions” to “systematic operations,” with the next phase of competition focusing on capabilities for global simultaneous development.
V. The Second Half of Global Expansion: Systematic Operations Across China, the US, Europe, and Japan
Following its listing, BoAn Biotech entered a fast track of development under the leadership of Jiang Hua.On the product front, the biosimilar pipeline continues to yield results, while the innovative pipeline advances steadily:
Marketed: Denosumab, bevacizumab, and other biosimilars
Phase III Clinical Trial: Multiple products, including aflibercept and dulaglutide, are among the leading candidates in China in terms of development progress.
Innovative Pipeline: CLDN18.2 ADC, masked PD-1/IL-2, bispecific antibodies, etc.
In terms of internationalization, a synchronized development system across China, the United States, Europe, and Japan has been established. Products such as BA6101 (denosumab) and BA1102 (subcutaneous formulation of denosumab) have entered Phase I clinical trials in the European Union.In Yantai High-Tech Industrial Development Zone, BoAn Biotech’s intelligent manufacturing base is continuously expanding. Strictly adhering to the GMP standards of China, the United States, and Europe, this production facility is becoming the core pillar of the company’s global supply chain. In 2026, BoAn Biotech also introduced an autonomous in-plant logistics system, setting a benchmark for smart manufacturing in the biopharmaceutical industry.Looking ahead, Jiang Hua’s assessment is clear: China’s biopharmaceutical industry has moved beyond the “catch-up” phase and is progressing toward “keeping pace” and even “taking the lead.” BoAn Biotech’s task is to pinpoint its strategic position in this evolution and continuously build differentiated competitive advantages.
Conclusion: Becoming the "Windbreaker" of the Industry
In cycling races, the "wind breaker" is the rider who leads at the front, shielding teammates from wind resistance. Jiang Hua greatly appreciates this metaphor."The development of the biopharmaceutical industry requires individuals who are bold enough to venture, experiment, and lead the way," she said.From a Fudan University graduate to Vice President of Luye Group, and from CEO of BoAn Biotech to the helm of a publicly listed company, Jiang Hua completed her transformation from a professional manager to an industry leader over 26 years. Though not a founder with a technical background, she leveraged clear strategic judgment and robust operational management to guide a technology-driven company through its leap from R&D to commercialization, and from domestic roots to global presence.The acceptance of the IND application for BA1203 is merely a milestone on BoAn Biotech’s journey of innovative transformation. In Jiang Hua’s vision, this biopharmaceutical company emerging from Yantai has a longer path ahead—progressing from following to running alongside, and ultimately to leading, thereby becoming a truly globally leading biopharmaceutical company.And she is willing to be the "windbreaker" who charges ahead.References:Public Notice of Application Acceptance on the Official Website of the Center for Drug Evaluation, National Medical Products Administration"Phoenix Face | BoAn Biotech CEO Jiang Hua: From Following to Leading, Bravely Becoming the Industry's 'Windbreaker'" | Phoenix News Shandong Channel"Yantai CPPCC Member Jiang Hua: Building a 'Yantai Name Card' in the Field of Biomedicine" | Yantai Daily"BoAn Biotech Enters the Multi-Billion Dollar Bevacizumab Market Race" | Luye Pharma Group Official Website“BoAn Biotech Officially Lists on the Main Board of the Hong Kong Stock Exchange” | Luye Pharmaceutical Group Official Website“Half-Year Revenue of 220 Million: Peking University’s 59-Year-Old Founder Races Toward IPO” | 36Kr"From Single-Point Transactions to Systematic Operations: Who Will Succeed in the Second Half of Chinese Innovative Drugs Going Global?" | Sohu.com"Successful Convening of the China-Japan Pharmaceutical Industry Exchange Conference" | China Association for Pharmaceutical Innovation"BoAn Biotech's Clinical Data Update on CLDN18.2-Targeting ADC Presented at 2026 ASCO Annual Meeting" | Sina Finance"BoAn Biotech's BA1203 Clinical Trial Application Accepted by CDE" | NetEase News"BoAn Biotech Chairman Jiang Hua: Buying Stocks Is Buying the Chairman" | Xueqiu"BoAn Biotech Chairman and CEO Jiang Hua: Continuous Learning Ensures Everlasting Success" | Qilu Evening NewsScan the WeChat QR code to add the Antibody Circle editor; eligible individuals may join.Antibody WeChat Group!Please indicate: Name + Research Direction! EditionQuanVoiceMingAll reposted articles on this official account are intended solely to convey information, with clear attribution to the original source and author. Media outlets or individuals who do not wish their content to be reposted may contact us at cbplib@163.com, and we will promptly remove the relevant material. The views expressed in all articles are those of the authors alone and do not represent the position of this platform.