Editor’s note:
This month, Luye people around the world celebrated the 30th anniversary of Luye. As time passes by, generation after generation of Luye people have been riding the waves and going forward for the common goal. Luye people have achieved remarkable milestones in this journey. This month we have invited 4 nominees from Luye Style Award to share their stories with Luye.

 

Challenge new heights with joint efforts
 

 
Mi Xuan, Senior Manager of Regulatory Affairs and Registration Department, Luye Pharma

Mi: I joined the company in 2015, which coincided with Luye's acquisition of Acino, and I was fortunate enough to be involved in the due diligence on regulatory matters throughout the process. After that, I was mainly responsible for project management and importation registration. I have experienced the whole process, from Luye's acquisition of an international company to its successful landing, and worked with my colleagues to successfully promote the R&D of transdermal patches, accelerating Luye to become a leading company in this field.

Q: For pharmaceutical R&D projects, time is one of the key elements for us to capture market opportunities and enhance our competitiveness, and your department has a crucial role to play in this. Please tell us how we promote the successful approval of the projects to the market in an "early, fast, good" way.

Mi: The first is to develop a scientific registration strategy that challenges the norm, streamlines the process, and promotes program acceleration. The launch of project LY03011 (Rivastigmine Transdermal Patch) coincided with the reform of the domestic pharmaceutical review and approval system. We took advantage of this opportunity to promote the policy reform through multiple channels, realizing the simplification of the complex clinical approval process. This product has become the first imported generic drug that completed the simplified procedure directly after BE filing, and has shortened the review timeline, which is more than one year faster than the previous procedure.

Secondly, we should lay a firm foundation and be fully prepared. A quality product registration process, is not only to lay a firm foundation in regulatory affairs, but also to master the basic skills of professional and technical knowledge of products. Transdermal patch is a complex formulation that is difficult to develop and produce. As the R & D of transdermal patches in China is still in its infancy, there is a lack of relevant regulations and guidelines. Ms. You Chunna, Senior Vice President of R & D Center, took the lead as head of the project. She led us to set up a scientific and technological research team with colleagues from the analysis and formulation departments to find all the relevant guidelines in Europe and the United States for translation and study. With the support of our German colleagues, we combined the project information with a full understanding of the R&D and production process of the patches as well as the requirements of the guidelines, and then translated and introduced the mature transdermal patches guidelines in Europe and the United States to the public.

In order to standardize the expression of transdermal patch specifications in China, we held communication meetings with CDE. We proposed to the Pharmacopoeia Committee to revise the general rules for patches in the Chinese Pharmacopoeia. After five rounds of discussions, they finally adopted our proposal and wrote the internationally accepted specifications for transdermal patches into the Chinese Pharmacopoeia. We also published academic journals, which enabled more experts to see the potential of transdermal patches, and to a certain extent contributed to the fervor of transdermal patches research and development in China. CDE drafted the first transdermal patches guideline in China in combination with the foreign guidelines, and took Luye's professional opinions in the process.
 

Luye presented EU and the US transdermal patches specification to CDE experts 

Finally, I believe that in order to achieve breakthroughs, we must, on the one hand, dare to challenge the limits and set high goals; on the other hand, we must take the initiative to ensure the realization of high goals. In recent years, with the adjustment of domestic regulations, the raw and auxiliary packages need to be reviewed in association with the formulation. There are nearly 30 raw and auxiliary packages in our projects, and all of them come from overseas suppliers, who do not know the Chinese regulations, so the workload and difficulty were tremendous. Our department took over the job with the leadership and support of Ms. You. Through the help of our colleagues in Germany, we actively communicated with the supplier to introduce Chinese regulations and persuade them to provide more information. Since the overseas suppliers did not have the energy to write the Chinese registration dossier, our department completed the translation of the technical information, completed the registration documents according to the Chinese requirements, and solved various problems, so as to avoid affecting the review and approval of the project.

Review what we have done in the previous projects, we set the goal of pursuing the extreme and pushing the limits at every step of the process. During NDA filing of LY03013, our work was influenced by the pandemic, however, we spent day and night to break the limit and completed NDA filing one month ahead of schedule. We have also overcome difficulties during registration inspection and passed the review with 0 defects. With the cooperation of the Chinese, German and Swiss teams, the supplementary documents were submitted 5 months earlier than the timeline required by CDE.

Q: We have accumulated valuable experience with the landing of these projects. When we look back, do we see any improvement opportunities in our work?

Mi: The registration work begins before the project is launched and continues throughout the project's life cycle. It covers not only the registration itself, but also the risk assessment and mitigation, strategy development and implementation of the project, and therefore requires the efficient collaboration of various departments.

After the kick-off of LY03013, based on the good communication and cooperation between us and the German team in the previous project, Luye Germany took the initiative to provide detailed information and minutes of the five formal communications with the European, American and German regulatory authorities. We translated and analyzed the information, and had in-depth discussions with the Medical Department to gain a full understanding of the program's oversea data. In the pre-IND stage, we make full use of the opportunity of regulatory reform to apply for a simplified clinical protocol using existing overseas clinical data. At the same time, we focused on exploring the clinical value of the product, combining the development process and communication information from Europe and the United States to introduce the advantages of this product as an international cutting-edge product to the CDE. As more data were submitted, the product was progressively streamlined for domestic clinical trials and eventually got a waiver for domestic BE. We have realized the completion of all deliveries of BD agreements three years ahead of schedule, which also enables domestic patients to have earlier and faster access to leading international new drugs.

These two projects have given me a deep understanding of the need to design a more optimized project strategy based on a full understanding and knowledge of the project to avoid risks. This requires full communication, information sharing, cooperation and teamwork among all departments of the project team.

 

Q: What would you like to say to Luye on its 30th birthday?

Mi: Luye has accomplished great things over the past 30 years, we have achieved breakthroughs in many areas, providing innovative solutions to benefit more patients, and I am proud to be a part of it. I am very grateful to have a group of like-minded partners along the way, and my leaders have provided me with a lot of guidance and help in my work. Colleagues from the German and Swiss teams provided us with very strong support throughout the project. The members of the domestic project team in each department, as well as Ma Wenyan and Wang Haiying, who worked side by side with me in the department, all worked hard on this journey through thick and thin.

Growing up with Luye
 

 
Bu Xianhao Sales Manager of East China Region, Wuhu Luye

Bu: I joined Wuhu No.2 Pharmaceutical Factory in 1990, which is the former entity of Wuhu Luye. With the acquisition of our factory, I joined Luye in 2001.

Q：As a veteran employee of the Group, you have experience in different positions, witnessed the development of the Group, and accompanied the Group to gradually realize your personal growth, please share your professional insights in these years.

Bu: I have worked in Finance Department and Manufacturing Department for 5 years when I joined the company. In 1995, the market economy became the mainstream, combined with personal career development planning, I embarked on the road of marketing nearly 30 years ago. My sales footprint spans Shandong, Sichuan and Chongqing, Southwest China, and now East China. Looking back, I have made certain achievements in each market, especially after the official establishment of Wuhu Luye in 2001, our sales work developed into a large-scale organized team operation, sales have achieved skyrocket growth. I felt the embodiment of personal value and also won the trust of the company's leadership. I think everyone should pursue excellence in their positions. More importantly, we should have the courage to challenge difficult markets, places with greater potential to create higher incremental benefits for the company.

Q：In the face of the impact of the national centralized procurement policy, you led the team to challenge all the difficulties and achieved a significant increase in business, please share your solutions and the innovative marketing models.

Bu: In 2009, I took over the East China market, mainly in Jiangsu, Zhejiang and Shanghai, which was in the period of China's rapid economic development, and the pharmaceutical industry also ushered in the golden era, and we seized the opportunity to obtain an outstanding performance.

However, since 2020, the national centralized procurement policy has gradually come into effect, and the Jiangsu, Zhejiang and Shanghai are the most economically developed regions in the country and also the most strictly regulated regions. Our products faced brutal drug pricing restrictions and had to give up many markets in the region, resulting in a significant decline in sales in 2021-2022. With the epidemic coming to an end in the second half of 2022, it's a good time to reinvigorate sales. Chinese traditional medicine is the main field of Wuhu Luye, which is closely related to the comprehensive health industry advocated by the government. We have actively explored the out-of-hospital market for our products and market characteristics, shifting from public healthcare organizations to various segments such as OTC and private hospitals. We have expanded sales, especially in chain drugstores, and achieved a surge in 2023.

Take the main product Shenkangning as an example, under the strong support of the company's leadership and various departments, we applied for OTC package, thus entering the field of comprehensive health. The product was successively launched in Zhejiang and Jiangsu in 2023, and sales reached 26 million yuan in that year, with a 90% year-on-year increase in sales in the East China Region, which created a new chapter of out-of-hospital sales. The Guangdong and Southwest markets are currently being successively rolled out and are expected to create a good result this year.

 
Based on our market research, we have also expanded sales of out-of-pocket products. Given the current trend, we are also aiming for the aging population, a number of products will be promoted to this market.

Generally speaking, our sales model has expanded from public hospitals to all the other channels. We do not want to stick to the original model; instead, we are looking for more incremental space to mitigate the risks posed by national and regional policies so that we can achieve sustainable growth.

Q: What would you like to say to Luye on its 30th birthday?

Bu: It has been 30 years since I have been in this industry. Looking back, not only have I achieved personal growth, but more importantly, I witnessed Luye achieve all these extraordinary results. I hope that we can continue to ride the waves and create a brighter future in the days ahead.

Luye 30, we expect a promising future ahead
 

 
Li Yunjing, Manager of Stock Solution No.1 Workshop, Boan Biotech

Li: I joined Luye in 2011, responsible for the production of sterile preparations, and in 2017, with the expansion of the company's business, I was transferred to the Antibody Workshop to lead the construction of the workshop, the technical transfer of new products, and GMP certification at home and abroad. In addition to daily commercial production, we are also responsible for the preparation of oversea filings for some of our projects as well as the continuous improvement of products manufacturing.

Q: You and your team have provided full support to the launching preparation of Boyounuo, Boyoubei, and Bouluojia. Could you please talk about what you have done during the process?

Li: Product landing is divided into several stages: technology transfer, process exploration and confirmation, process validation, product approval, inspection and certification. We communicate product and process information according to project progress and R&D, confirm material demands for purchasing, perform gap analysis of equipment and small-scale production, complete personnel training, and prepare documents. For process validation and product approval, we will take into account past experience, regulations and policies, and experts' suggestions to develop a strategy, in order to meet the reporting requirements of the multinational market, and at the same time, we will also complete the pre-certification preparations to ensure that the inspection is successfully passed.

We now have a well-organized work pattern, but it wasn't all plain sailing at first. When the antibody workshop was established, most of the personnel lacked GMP and biopharmaceutical manufacturing experience. Therefore, we have carried out targeted learning and training. We sent employees to the pilot plant to follow the production training and, combined with past experience, conduct an on-site simulation of self-inspection. All three products have now been certified for the Chinese market, and Boyounuo has also received GMP certification from the Brazilian Agência Nacional de Vigilância Sanitária (ANVISA). Boyoubei and Boluojia are also preparing for certification in the European, American and Japanese markets, all of which will lay a solid foundation for Boan's future globalized business layout.

Q: Cost reduction and efficiency improvement are important requirements advocated by the group in recent years. Your team has achieved outstanding results in them; please share with us the measures and outcomes.

Li: This is a group effort. In accordance with the principle of "cutting costs and reducing expenses, implementing and tracking", we have formulated differentiated measures in accordance with the situation of different products. Boyounuo has been in production for three years, and in the first two years it has already realized the domestic replacement of many types of consumables, so this year's focus is on open source. We used big data comparison and analysis to find the key to open source, starting with the yield, comparing the yield of each process of the two production lines, boldly analyzing the differences, and carefully seeking proof. The current yield of the Boyounuo 1.0 process in second-line production is eight percentage points higher than last year's, with an average of about 2,000 vials more output per batch.

The focus is on cutting costs while maintaining production, making domestic substitutions and reducing material consumption in production to lower input costs, as Boyoubei and Boluojia are just started to be commercially produced. These two products have now realized a cost reduction of $90,000 per batch, which is still substantial based on total annual production.

Personnel is also very important. We formed different groups according to the main tasks: regular sharing of theoretical knowledge to enhance the ability of personnel; regular tracking of the progress of each group; communication review; and discussion of the next stage of adjustment. In the future, there will be further room to optimize cost reduction and efficiency from the GMP perspective as well as manpower efficiency improvement.

Q: What would you like to say to Luye on its 30th birthday?

Li: Luye has been through twists and turns in the past 30 years. We have developed well-recognized products and stick firm to innovation and internationalization. I hope we can be more fearless and embrace the next wonderful journey.

Innovation creates value
 

Andrew Swadling, Head of IT Engineering, Aurora Healthcare 

Andrew: I have worked here for almost 7 years. Prior to that, I worked for outsourced IT provider that used to provide services to the company. I have been around the business for close to 13 years.

Q: What are the challenges facing the Australian business against the backdrop of COVID-19 and policies that have affected it in recent years? What changes need to be made?

Andrew: I think one of the biggest changes during COVID-19 was the work model. Employees suddenly needed to be able to work anytime and from anywhere. We saw a huge uptake in virtual meetings. The IT team had to rapidly adapt to be able to support and ensure the smooth operation of these meetings. The other main issue is cyber security, in the past 2 years there have been a number of high profile cyber-attacks against health organizations in Australia that have disrupted operations and leaked sensitive patient data. So it is our responsibility to maintain cyber security against hacking within Aurora for the purpose of protecting patients’ and company information.

The COVID-19 pandemic had a large impact on the mental health of many people. Many of our existing patients were not able to visit our hospitals and clinics due to pandemic related restrictions. Telehealth started to surge during this time. In the last two years, Aurora Healthcare has launched the Aurora Cloud Clinic to those in need. It is a telepsychology and tele-psychiatry practice, focused on delivering quality mental healthcare online. Aurora Cloud Clinic is connected to our private hospital network, with psychologists and psychiatrists being a part of this online service.

Aurora Cloud Clinic

Q: How did you leverage innovation to streamline processes to drive the successful execution of programs within Aurora Healthcare?

Andrew: We have leveraged digitization and innovation in several aspects. First, we have used it in the staff onboarding process and incorporated automation where new employees can get provisioned and set up in a matter of a few minutes, which significantly streamlined the process and enhanced efficiency.

Second, we are also looking for solutions to improve patients’ experience and where we can use AI and other technology to streamline this process and reduce manual steps during the referral to our hospitals. For example, the ability to take information from referral emails or calls and prefill all sorts of admission paperwork to improve the admission process. 

Also, we are working on improving the website functions, which can capture all the information filled out in the patient forms without having to interact with them. We aim to have this new functionality tested and launched by the end of Winter.

Q: What would you like to say to Luye on its 30th birthday?

Andrew: Happy birthday to Luye! I hope we can have a bright future. From my perspective, I will continue to work on digitizing and bringing innovative technology to our office for better and more efficient operations.