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Editor’s Note:
This March, Luye Pharma announced the launch of its innovative drug Zepzelca® (lurbinectedin) for the treatment of SCLC in both Hong Kong and Macao during a symposium held in Hong Kong. The product has received approval in Macao and Hong Kong in November and December in 2023. It is also under review for NDA with a priority review designation in Mainland China, which is expected to benefit more patients in the near future. Since the kick-off of this project, the Group has decided to accelerate the process. With the co-operation of colleagues from different departments, we overcame a lot of difficulties and succeeded in obtaining the approval for both Hong Kong and Macao within a short period of time. This month, we invited several colleagues from the project to tell us the story behind the project.
Q: Welcome and thank you all for taking this interview, to start with, please give us a brief introduction of yourself.
Cally: My name is Cally, I joined Luye Pharma Hong Kong in January of this year. I’m responsible for sales, customer communication, logistics and marketing.
Mo: My name is Mo Huayu, I joined Oncology Drug Marketing Department of Luye Pharma in May, 2023. I’m currently responsible for marketing in Guangdong, Fujian and Jiangxi. For Zepzelca project, I’m responsible for product promotion in regional markets, including maintaining expert relationship, establishing academic platform, following up with the project progress in Guangdong-Hong Kong-Macao Great Bay Area.
Olivia: I’m Olivia Gao from International Regulatory Affairs Department of Luye Pharma. I joined the company in September 2020 and serve as Senior Manager of RA. I’m responsible for the registration and application of Zepzelca in Hong Kong and Macao.
Sun: My name is Sun Min, I joined Luye in May 2017, and I am currently the Director of the Group's R&D Medical Writing team, responsible for the development of clinical strategies during launch process, pharmaceutical administration communication, writing of key medical documents, and medical support of clinical operations. I joined the Zepzelca project team in 2019, responsible for the development of NDA strategy and the writing and communication of relative materials for Mainland China, Hong Kong and Macao markets.
Q: International Regulatory Affairs Department succeeded in achieving dual approval in Hong Kong and Macao in the same year despite a lack of resources, please describe the challenges and difficulties you encountered in this process. What is the significance of the successful approval of this product?
Olivia: The situation we were facing is: Zepzelca received conditional or temporary approval in all approved markets, and none of them are from the European market. We kept in touch with the project team, PharmaMar and the local partner to provide a response strategy, and provided a clear and convincing response within a short period of time. In addition, we took the initiative to communicate with the Department of Health of Hong Kong for more than 30 times by email and telephone, providing various proofs in response to their queries and further explaining the effectiveness and safety of the product. In particular, we emphasized that the product was the first drug approved globally since 1996 for the second-line treatment of small-cell lung cancer (SCLC) and that it was effective in improving patient survival rate. These communications greatly reduced the regulator's concerns about Zepzelca and resulted in approval of the product.
Regarding the registration in Macao, we had very limited time to develop strategy and prepare filing documents. We took the initiative to communicate with local authority after submission, thanks to our successful experience in Hong Kong, we were able to get the approval within a short period of time.
As the first product approved for the treatment of small cell lung cancer in the past 30 years, Zepzelca can effectively improve the survival rate of patients. The dual approval through Hong Kong and Macao can benefit the Greater Bay Area in the Mainland and be used for treatment in designated hospitals, addressing the unmet clinical needs of more patients, which is a very important milestone.
Q: How are resources being allocated across different aspects of the launch, and what criteria are being used to prioritize tasks within the limited timeframe?
Cally: Faced with the challenge of the tight project schedule, everyone had their own role to play and worked closely and efficiently to ensure the smooth progress of the launch process. First of all, Andy Siow, as the team leader, gave great support to this work, and he fully mobilized colleagues from different departments of the Group to provide support to us. Under his co-ordination, we got positive responses and support from BD, marketing and other departments, which provided us with product information and expert resources. As I joined the company not long ago, my administrative colleagues in the Hong Kong office also provided me with a lot of guidance in terms of document preparation and IT, which helped me engage into the workplace quickly. Starting from February I started the pre-launch preparations together with Regional Manager, sorting out all the relevant processes and details of the launch event. We confirmed all the details regarding the event with the local government, then clarified the framework of the presentation and keynote speakers, and worked with my colleagues in the Mainland, who coordinated the invitation of experts from the Mainland to participate in the launch event in Hong Kong.
The launch ceremony of Zepzelca®(lurbinectedin)
Mo: My job during the pre-launch phase was to communicate with keynote speakers and guests in Mainland China. As this launch event requires the speakers to give a speech in English, while the mainland experts are used to using Mandarin in their daily life, we had many rounds of communication with the speakers on the content of the PPT, and the whole set of presentation materials had been revised several times, which was a time-consuming task but ensured that Zepzelca's features can be perfectly presented at the event. The Hong Kong venue was nicely set, very ceremonial. We can learn from their experience and apply it to our launch ceremony in Mainland China in the future. What impressed me a lot during my involvement in this project was the fact that the team had weekly meetings and communicated the progress of everyone's work online, which laid a great foundation for a successful event.
Site photos of the launch ceremony in Hong Kong
Q: With the approval of Zepzelca in Hong Kong and Macao, we can take GBA initiatives to further benefit patients in Mainland China. Please tell us more about the progress of Zepzelca 's rollout in the Mainland, especially in the Greater Bay Area, and its future development.
Mo: With the approval in Hong Kong and Macao, we can take the advantage of GBA policy--“Measures of Using Hong Kong/Macao Registered Drugs and Medical Device in GBA”. This is a pilot policy allowing to use drugs or medical devices that have been registered in Hong Kong and Macao and are in urgent clinical need in designated medical institutions in 9 cities of the Greater Bay Area. Our team is working hard to get Zepzelca listed in this project and promote to designated hospitals. Currently two public hospitals in Guangzhou have filed application to use Zepzelca and good news is expected in the near future. We will continue to follow up with other hospitals’ applications as well. Through the implementation of this project, we can further deepen the contact with medical institutions and drug regulatory authorities, laying a solid foundation for future clinical promotion and market access. In addition, as the region I am responsible for is Guangdong and Fujian, which is very close to Hong Kong and Macao, the news of Zepzelca 's listing in Hong Kong and Macao has brought confidence to my region, and it is also a great encouragement to the mainland experts as they see the recognition of Zepzelca in the Hong Kong and Macao markets and even in the international market.
Poster of “Measures of Using Hong Kong/Macao Registered Drugs and Medical Device in GBA”
Q: As we know, the drug is under review for NDA in Mainland China. Since you are one of the members who have participated the work in Mainland, Hong Kong and Macao. What challenges you have encountered along the way? How do you think the successful approval and launch of Zepzelca in Hong Kong and Macao will help its subsequent promotion in the Mainland?
Sun: As the Group's first new drug product licensed from overseas, applying for clinical trials in China is a big challenge for us, especially in the IND preparation stage. In the face of a large amount of data, including IND data, clinical trial data, and data for NDA filing, how to use and integrate the data, and how to formulate an effective strategy. This was a brand new question to all of us. Therefore, we have conducted multiple rounds of internal and external communication and discussion. In terms of IND, in order to ensure the Group's rapid filing schedule and to cope with possible filing risks, we developed two sets of plans, including rationalization and revision of the initial data and translation of the necessary foreign filing data. In terms of strategy formulation, based on the overseas clinical data of this product, we boldly proposed a simplified bridging strategy through the research and review of similar varieties and expert consultation, and reached a consensus after repeated discussions with the drug administration department. According to this strategy, we have completed the domestic bridging test declaration, which has accumulated important experience for the Group's future development of similar products.
CDE has always advocated a patient-centered and clinical value-oriented approach to drug research and development. We believe that against the backdrop of the urgent need for drugs for the second-line treatment of SCLC, overseas, Hong Kong and Macao data, as well as domestic data, can prove the drug's good therapeutic efficacy, and that the approval in Hong Kong and Macao will play a significant role in helping the product's approval in the Mainland.
Q: The successful approval of Zepzelca in Hong Kong and Macao has been a long and complex process. How are communication channels established and maintained between team members from various departments? Are there clear lines of communication to address any issues or bottlenecks that may arise during the launch process?
Sun: The special part of this project is that it is a license-in drug, which involves continuous communication both internally and externally. Although there have been bumps in the road, the final result and outcome are good, and I think this successful teamwork is due to several aspects: 1. We share the same mission and targets. Given the circumstances that no new drug has been approved in the field of second-line treatment for SCLC in the past 30 years, Zepzelca's overseas efficacy and safety data are relatively excellent, and we all hope that we can push forward the approval of this product in Hong Kong, Macao and the Mainland as soon as possible, so that more patients can be benefited. 2. Clear communication management system. The project team established a clear communication mechanism and clear division of responsibilities at the beginning of the project, with professional colleagues in each department and each link, and communicated with each other in a timely manner through regular meetings, debriefings and ad-hoc meetings on the problems in the project. 3. Successful teamwork needs to be built on the basis of mutual trust and effective communication. In the process of project promotion, we are allowed to put forward different ideas from different perspectives, and the trust between each other allows us to listen carefully to the problems, and reach a consensus based on a common goal. And with the support and promotion of the leadership, we make a commitment to jointly implement the decision.
Olivia: I believe that in the process of project promotion, we must take the initiative and proactively communicate with the drug administration authorities to obtain first-hand information and understand their feedback and concerns. categorize the issues collected, and inform the project team, provide specific explanations for different issues and seek support from relevant departments. I think everyone is very cooperative in this project, which is a crucial point, and we all reached a consensus and moved together towards the same goal.
Cally: I haven't joined Luye for a long time, but by participating in this project, I can feel that the whole team is very united, Andy has provided a lot of support and coordination in this process, colleagues from various departments respond quickly to our needs, each part of the project is closely related, everyone in their respective positions to make resources available, and we all work towards the same goal.
Mo: Our collaboration on the GBA initiative is a good example to demonstrate a good teamwork. The “Measures of Using Hong Kong/Macao Registered Drugs and Medical Device in GBA” is a completely new policy, we don’t have any past experience to refer to. This project requires support and collaboration from multiple departments. At the beginning of the project, the team leader sorted out the timeline for us, clearly defined the tasks to be completed at each time point and the corresponding responsible departments, and we would share the progress with other members in a timely manner in the form of emails to ensure that all departments could complete the tasks they were delivered within the stipulated time. We have passed pre-review and submitted Zepzelca’s application to Guangdong Provincial CDE. The next step is to support hospitals to deliver files to regulatory authority. After our application is granted, we will work with hospitals on product communication and bring this product to more patients in Mainland China.
Q: Luye’s 30th Anniversary is coming, please share your future expectation.
Sun: A big ambition will go a long way. I hope the company will be able to launch more and better drugs in the future for the benefit of the public. I am honored to be able to work together with a group of excellent colleagues to contribute to the vision of "to be a leading global pharmaceutical company".
Mo: I hope that Luye can have more good products on the market in different fields in the future, and I also hope that Luye can create more competitive technical barriers in its strength areas. I feel that I still have a lot to learn and improve, and I hope that I can grow together with the company in the future.
Cally: Through participating in this project, I can feel that the management of Luye has a forward-looking thinking on the future market, and I hope that Luye Pharma can launch more and better products in its focused disease areas, so as to benefit more patients.
Olivia: I hope Luye can bring more and more good products to patients in the future.
Afterword:
The successful approval in Hong Kong and Macao, as well as the pilot scheme in GBA further expanded Luye Pharma’s product portfolio in the field of oncology drugs. As the first product approved for the treatment of small cell lung cancer in the past 30 years, Zepzelca brings hope to patients with urgent needs. The project has been able to achieve these results in a short period of time thanks to the efficient co-operation between the members of the project team. As Andy Siow, APAC VP of Luye Pharma (International), said:
It's truly splendid and rewarding to witness a cross-functional team working tirelessly to ensure the success of such an important launch within a remarkably short timeframe, and with a packed audience of top-notch faculty members, healthcare professionals (HCPs) and key opinion leaders (KOLs). As we prepare for the first commercial invoice the next days and the first commercial patient being served, we reflect on the dedication and effort that has brought us to this milestone. With the introduction of Zepzelca in Hong Kong and Macao, we once again demonstrate the capabilities of Luye Pharma, affirming our position as a competitive player in any region. This success will also generate increase interest and uptake of Zepzelca in China & GBA. Our passion lies in serving all patients, expediting their access to this medication, and ultimately improving their chances of survival while easing the burdens of treatment.