On July 5th, colleagues of Luye Pharma Group gathered to celebrate the marketing authorization (MA) approval of Goserelin Microspheres for Injection (Baituowei) in China. Baituowei is a globally unique product and developed independently by the Group. 

The celebration ceremony was attended by Mr. Liu Dianbo, Chairman of the Group; Mr. Yang Rongbing, President of the Group; Dr. Fu Fenghua, Executive Vice President of Group R&D; Mr. Li Shixu, Vice President of the Group and General Manager of Shandong Luye; Ms. You Chunna, Senior Vice President of Boan Biotech R&D Center; Dr. Liu Wanhui, Vice President of CMC of Group R&D; Dr. Tian Jingwei, Vice President of Non-Clinical Research Department and Head of New Drug Discovery Department; Dr. Sun Kaoxiang, Vice President of Formulation Research Center; as well as members of the goserelin project team and representatives from various business departments.

The ceremony was not only held at the main venue but also had satellite venues in Beijing and Shanghai. It was also live broadcasted to the entire Luye Pharma Group, allowing employees from various locations to join in the celebration virtually and collectively witness the milestone moment.

 
▲Group photo of project team

A daring relay to chase our dreams

At the start of the celebration, an opening video took everyone through the journey of the LY01005 project, from its initiation in February 2010 to the MA approval on June 30, 2023, vividly showcasing the 13 years of unyielding hard work and dedication to overcome numerous challenges encountered along the way. Finally, like a butterfly breaking out of its cocoon, LY01005 became our unique product Baituowei, which will soon be available in the market to benefit patients.

Dr. Fu Fenghua, Executive Vice President of Group R&D, said, "The successful launch of the risperidone microsphere product two years ago demonstrated Luye's breakthrough in the field of long-acting sustained-release microspheres for small molecules. The approval of Baituowei today signifies our mastery of the long-acting sustained-release technology with microspheres encapsulating peptides. Our confidence in the success of this project stems from our expertise in this field. The 13-year development journey of Baituowei would not have been possible without the collective efforts of all project team members and relevant departments. We have also witnessed the rapid growth of both the teams and individuals involved in the project along the development journey. Looking ahead, we expect to deliver more innovative achievements.” In this exciting occasion, Dr. Fu also gave special thanks to all members of the project team and paid tribute to the late Dr. Li Youxin.

 
▲Dr. Fu Fenghua

Mr. Li Shixu, Group Vice President and General Manager of Shandong Luye, congratulated the company on adding another significant product to its portfolio and emphasized that the company has overcome manufacturing barriers surrounding the commercial production of complex injectables like microspheres, which are almost insurmountable for many competitors. He highlighted the various difficulties and challenges the manufacturing department navigated to realize such technical advantages. He noted that the first batch of Baituowei was already under production, and the factory was fully prepared for high volume demands. Mr. Li also expressed his confidence in the promising market potential for the product.

 
▲Mr. Li Shixu

Recounting an eventful development journey and giving best wishes for commercial success

The approval of Baituowei is the result of unremitting efforts to navigate and accelerate each step throughout the entire development process, from R&D, clinical trials, manufacturing to registration. Our colleagues rose up to challenges and overcame numerous obstacles along the way, achieving personal growth while accumulating valuable experience for the company.

Dr. Zhang Xuemei, the project leader of Baituowei and Director of Formulation Research Department, expressed her gratitude, saying, "After 13 years of perseverance, we have finally achieved our goal. I would like to thank the leadership of the Group for their continuous support and investment, as well as the support from R&D leaders who provided guidance during challenging times. I am also grateful to all the departments that collaborated efficiently with us in overcoming numerous obstacles. This is the company’s first peptide microsphere formulation. My team navigated innovatively through various difficulties along the way, from production materials, clinical trials to IND application. Looking ahead, we will accelerate the application for new indications for Baituowei to further unleash to its clinical value!"

 
▲Dr. Zhang Xuemei

Representatives from the Regulatory and Registration Department, CMC team, Manufacturing System, Clinical Operations Department, and Non-Clinical Research Department, namely Peng Fang, Li Chenglin, Yu Raolei, Wang Lamei, and Yu Pengfei, expressed their excitement at the approval of Baituowei and reflected on the unforgettable journey they and their teams went through to bring this product to fruition. They believe that these valuable memories and experiences will undoubtedly make them more professional and efficient at work, and help them deliver more innovative achievements for the company. The representatives also expressed their heartfelt wishes for Baituowei that it would be a big hit in the market, achieve extraordinary commercial success, benefit more patients, and create greater value for the company.

 
▲Project team members sharing development stories

 

Message from the President: Steadfast and accelerating forward

Mr. Yang Rongbing, President of the Group used four points to express his excitement about the successfully approval of Baituowei: “long-expected”, “worth the wait”, “memorable”, “motivative”.
 

• Long-expected - We have witnessed the development of Baituowei in the past 13 years, and also witnessed the rapid growth of the market size in this field from one billion to ten billion. 
• Worth the wait - Baituowei is our first microsphere product to achieve full industrialization and full supply chain. Baituowei is blockbuster product developed on the microsphere platform of the National Key Laboratory of Advanced Drug Delivery and Release Systems, and manufactured following the company’s quality management system that is compliant with the Chinese GMP, the U.S. cGMP and the EU GMP systems.
• Memorable - Over the past 13 years, generations of Luye people have been pushing the project forward with unwavering determination and shouldering the mission to forge ahead.
• Motivative - Complex preparations are technically difficult, we kept exploring all the way, making impossibilities possible and creating history in the field of preparations with high efficiency and synergy.

President Yang Rongbing emphasized that, the tenacity and perseverance of every Luye people allows us to cross the difficulties and achieve our goals step by step in the future. We will continue to focus on the company's key areas, innovate more clinically valuable products independently, and make full use of our existing R&D experiences to accelerate the launch of more products.

 
▲President Yang Rongbing

 

Chairman’s message: Stay strong to our mission and believe in the future

Chairman Liu Dianbo expressed his heartfelt congratulations to Baituowei during the celebration: during the past 13 years, we put a lot of work in this product from project kick-off to successful approval, and now we see the results. Thanks to the project team for their perseverance in living up to their mission and all the departments for working together. We would also like to thank our friends from the society who support Luye, and especially the governments at all levels for their strong support of this product and our corporate innovation.

 
▲Chairman Liu Dianbo

Chairman Liu said, starting from 2021 Luye has entered into a harvest time with the approval of Rivastigmine, Rykindo, Ruoxinlin, Boyounuo, Boyoubei, Baituowei. The approval of Baituowei is a milestone achievement for Luye, which has strengthened Luye’s position in advanced delivery. The strategic partnership with BeiGene will further promote the rapid commercialization of this innovative product through a strong alliance team to benefit more patients.

Chairman Liu further stated, over the past 10+ years of R & D, we have well explained our mission of "Advanced technologies for better quality of life". In the next two years, we have several new drugs that will be approved for marketing. With the current booming technologies such as AI, cross-science, cell and gene therapy, we will also combine advanced technology platforms and clinical needs to lay out new technologies and new areas for our next decade strategy.

Finally, Chairman Liu stressed that Luye already has a clear goal and direction to strive for, and in the future we will continue to be firm in our vision and mission to make our own contribution to human health with more and better products!

 
▲Group photo

“A straw shows which way the wind blows, Baituowei is heading for its vision”. The approval of Baituowei is a milestone and also a start of the new journey. We wish Baituowei for a successful launch, creating greater clinical and commercial value! We look forward to the early launch of more new products in the future for better quality of life with advanced technologies! We also wish Luye is getting better and better, and our business is prospering!

 
▲Highlights and moments of joy