21 Talks ｜ Ou Silang, Global Vice President of Albervis and General Manager of China: Digging high -quality tracks, staying away from the "Red Sea"

The 21st Century Business Herald reporter Ji Yuanyuan intern Guo Zhirui reported that in recent years, JAK inhibitors have become a popular track for domestic and foreign pharmaceutical companies. As of now, a total of 9 JAK inhibitors in the world have been approved for listing, 5 of which have been approved in China, including Berobitinib, Novartinib, Baritinib in Lilly, and Pfeluer. Tofuton and Abuqinni.

On April 6, the official website of the State Drug Administration showed that another listing application for Patininib in Albervi was approved for treatment for one or more dmards. Patients with sexual psoriasis (PSA). This is the third adaptation of the product after the product was approved in China to be treated with severe active rheumatoid arthritis and median dermatitis, and it has become the only targeted therapy for the treatment of PSA in China.

For Albervi, JAK inhibitors may become another heavy product after the "Medicine King" repair Meile. However, the JAK inhibitors had also been in security disputes and were warned by FDA security warnings.

Recently, Ou Silang, the global vice president of Albervis and general manager of China, said in an exclusive interview with the 21st Century Business Herald that the black frame warning comes from the security risks that may occur during the long -term application of the Pan JAK inhibitor. In fact, JAK inhibitors can be divided into pan -JAK inhibitors and selective inhibitors based on inhibitory activity of different subtypes. As a type of non -receptor tyrosine kinase, JAK includes four subtypes: Jak1, Jak2, JAK3, and Tyk2. Inhibiting different subtypes will bring different curative effects, and the safety is also different. Popotinib is the high -selective JAK1 inhibitor, which means that it has a stronger inhibitory effect on JAK1. While improving inflammation, it can reduce the risk of adverse reactions caused by multiple JAK subtypes at the same time. Better.

"We believe that through the real world data and other updated clinical trial data, it can further prove the security of the product from the US FDA and China NMPA. , Safety may be higher, then we hope to remove warnings, this is the direction of our future efforts. "Oslang said.

Heavy soldiers layout immunotherapy field

In recent years, with the continuous deepening of diseases, a lot of breakthrough progress has been made in the field of dermatitis, and the advent of innovative drugs has rewritten the treatment pattern of special dermatitis. On this basis, the safety and effectiveness of drugs have become the focus of attention. NMPA approved the indications of Upatinib for adolescents over 12 years old and adults, which made Upatinib the only JAK1 inhibitor that is currently covered with adolescent patients in this treatment field.

On June 18, Albervi announced that the US FDA approved its product Skyrizi (Risankizumab) for treatment of adult patients with severe Crohn disease (CD). The press release pointed out that Skyrizi is the first inhibitor to be approved for treatment of this patient group to target leukocytes-23 (IL-23).

With the help of Upatinib and Skyrizi, the product layout of Albervi in ​​the field of immunization has also developed from a uniqueness to a "three -legged power" trend. In 2021, Merlot, a subsidiary of Albervi, broke the 20 billion sales mark worldwide, reaching $ 20.694 billion. In the first quarter of 2022, Albervi net revenue reached $ 13.558 billion, an increase of 4.1%year -on -year. Among them, immune risks Risankizumab and Upatinib achieved more than 50%of high -speed growth. The rise of the two immunity has undoubtedly consolidated Albervi's leading position in the immune field.

Since its listing, Xiu Meile once occupied the title of "Medicine King". Today, cumulative sales have exceeded 180 billion US dollars, ranking first in the field of prescription drug sales. However, can the rising star stand on the shoulder of Xiu Meile's "giant"?

Ou Sirang is "full of confidence." He pointed out that the development speed and stage of Upatinib and Xiu Meile in China are different. In terms of the increase in indications in the Chinese market, Xiu Meile is lagging behind the global market. The time difference is relatively large. Popotinib is different. Basically, in China and various countries in Europe and the United States, they basically submit the review, approval and simultaneous listing of AD indications simultaneously. The importance of simultaneous listing is that the first is to ensure that the patent period of drugs in China is relatively long. Second, we can help more Chinese patients as early as possible to enjoy the latest innovative drugs like global patients.

"Subsequent Albervi will also promote the approval of the gastrointestinal and rheumatologist in the fields of Crohon disease, UC (ulcerative colitis), and mid -axis spine arthritis. Obtaining multiple indications is expected to benefit more patients in the future. "This is also because many patients not only have one disease. In addition to dermatitis, the" imbalance "of the immune system may cause arthritis or other problems. These issues may be treated by using the same drug. This is also a good confidence and encouragement for patients with many autoimmune diseases.

This means that on the basis of existing, new products need new operating models. It is impossible for Abervi to use the old way to operate the future opportunity. In the past, present, and future, the Chinese pharmaceutical market will change. It is essential for the success of an early access and fast marketing. Differential layout avoid "inner volume"

In fact, in addition to Upatinib, Albervi is also actively deploying other product pipelines. For example, after the acquisition of Eljian, Albervi opened up a new market in the blue ocean field of medical beauty. According to the 2021 financial report, Albervi revenue in 2021, a total of US $ 56.122 billion, and the immunization field contributed $ 25.284 billion in revenue; the tumor field contributed $ 7.228 billion, of which Venitra contributed to $ 1.82 billion; Eljian aesthetic contribution contributed At 5.233 billion US dollars, the classic products have contributed $ 2.232 billion in the aesthetic field.

In the field of tumors, recently, Albervi and GenMAB have also announced the main results of the expansion queue in the two phase clinical trials of EPCORITAMAB for the treatment of EPCORITAMAB for the treatment of large B -cell lymphoma (LBCL). EPCORITAMAB is a special CD20/CD3 bispecifier antibody. In this study, EPCORITAMAB has previously accepted a long -lasting effect of patients with at least 2 lines of anti -lymphoma.

The research queue includes 157 patients who have previously received recurrence or cure LBCL who have received median three -tier treatment before, with a total relief rate (ORR) of 63%and a complete relief rate (CR) of 39%. Patients who participated in the study did not receive CAR-T cell therapy for 69%ORR and 42%CR, and patients who had received CAR-T cell therapy obtained 54%ORR and 34%CR. After 10.7 months, the mid -position relieving duration (MDOR) is estimated to be 12 months. Compared with many steps that CAR-T cell therapy needs to be treated before treatment, bispecific antibody EPCORITAMAB has the potential to provide an effective treatment method for patients with LBCL.

Whether it is the continuous effort of Alier's beauty, or the BCL-2 of the hematological tumor, and the rapidly growing neuroscience, Albervi shows strong competitiveness. However, it has to be said that whether it is medical beauty or tumor, this market has always been competitive, and some track companies are even more diligently. The phenomenon of "inner rolls" due to homogeneous competition has frequently appeared.

According to the "Annual Report on the Status of the 2020 China New Pharmaceutical Registration Clinical Test" released by the National Drug Administration (CDE), the number of clinical trials for PD-1 target registration is up to 75, and the top 10 targets are serious Crowded. According to the analysis of Ping An Securities, from the perspective of my country's innovative drug research and development stage, in order to quickly follow up with the ME-TOO-type innovation track of mature drugs abroad, it has been crowded, and the homogeneity of drug development is significant, resulting in the listing of new drugs. Entry, such as PD-1 monoclonal anti-anti-drug drugs, eventually fell into the price, sales capacity and advance speed competition.

In this regard, Oslang believes that choosing some high -risk blank areas or the field of treatment that is not met to do targeted scientific research investment will not repeatedly put in R & D resources with other companies, or become the same The same repetitive test in a category kills in the "Red Sea" market. "Although the failure rate of some areas that really treats gaps will be relatively high, if it can be successful in the end, this will be our pride. More importantly, we can help patients. We also hope that different companies in the future can consider considering it in the future. Go to different targets, give research and development. "

"Indeed, there are many market opportunities in the field of tumors, but for some subdivided tracks, such as acute myeloid leukemia, it is difficult to develop and develop. But we see the clinical needs. "Oslang introduced, when our First-in-Class and Best-IN-Class products BCL-2 inhibitors are only available (Vennachra tablets), the industry is incubated, the industry, the industry, the industry High expectations. After all, there are still a large number of unsatisfactory treatment needs in the tumor field, which requires companies to invest more energy into product development, fully tap high -quality tracks, and make differentiated products.

Building a trend of multi -party cooperation becomes a trend

With the normalization of government medical insurance fees in the future and the intensified market competition, IQVIA predicts that the potential risks of innovative drug income will affect the investment intensity and direction of the company's own funds on research and development. The traditional leading pharmaceutical companies will make full use of the stable cash flow and sales platforms of existing products, quickly realize the commercialization of ME-Better products, move forward steadily, and gradually transform into innovative drugs. With the improvement of R & D efficiency and strength, R & D-oriented enterprises will continue to invest in the research and development of FIRST-IN-Class products, and actively participate in the competition in the local and international markets.

Soochow Securities also believes that the new FIRST-IN-CLASS drugs pay more attention to the verification of the target mechanism, especially the consolidation of preclinical research. Best-in-Class, ME-Better, and Me-Too products are more for the differences in molecular structure, which is also more suitable for the R & D strategies of most pharmaceutical companies. Therefore, Fast-Follow-ON is one of the breakthroughs for companies to seek maximum value. It should make full use of the domestic innovative drug series of drug administrations, especially the attachment of tumor drugs and rare medical drugs to accelerate listing strategies. In this way, how to do a good job of market layout has also become a major focus on the focus of various pharmaceutical companies. Oslang introduced that under the premise of seeking differentiated pipeline layout, Albervi also needs to build a professional market access team. Not only simply conducting medical insurance negotiations, the team is also exploring some diversified models that can help the sustainable development of the product, including cooperation with other commercial insurance and digital platforms. This is also because of the current market, product promotion is no longer the most mainstream key task. The most important thing is to work with multiple parties and cross -border cooperation to create good solutions to patients.

"In the past, many pharmaceutical companies promoted the product to the whole country through the" Human Sea Tactics', but in the future, the market has more requirements for elites with a certain scale, which can bring more optimized solutions to customers. Birvi has established the 'Strategy and Innovation Division', which can give more patient -centered innovative resources and operating plans, including the management of patients' whole disease management. Good medical care. "

This also highlights the necessity of multi -party cooperation, especially under the trend of globalization, multinational pharmaceutical companies also need to promote cooperation with local innovative pharmaceutical companies. As the Analysis of Guojin Securities believes that in recent years, the development and commercialization of innovative drug products from overseas markets in China has become an important source of supplementary pipelines for pharmaceutical companies, which has further accelerated the leading new type of innovative drugs in the overseas research and development stage The domestic research and development progress and accessibility are conducive to China's accelerated innovation research and development and further connecting the international leading level.

Oslang introduced that at present, Abervi has established cooperation with three local pharmaceutical companies in China, Heaven Bio, Platinum Medicine and Gacosi. So far, cooperation is in the stage of product development, and it may also promote the commercialization process of products in the future. For example, cooperative development and commercial SHP2 inhibitors with Gakos Pharmaceuticals, targeting the key targets of cancer cells and immune cells, as well as the development of innovative CD47 single cloning for the treatment of various cancers with heaven biological cooperation. Antibody Lemzoparlimab, etc. "These cooperation can help innovative drugs to land quickly, not only can operate in the Chinese market, but also to go to sea. In addition to the development of the contract, the product volume can also be carried out after listing. This is also a win -win cooperation model."

In the intention of cooperating with local pharmaceutical companies, Oslang said that Albervi was very willing to cooperate more with more local companies. "We are not particularly limited to the field of disease. As long as the product has good clinical value and good innovation, we will be very interested."

- END -