Nalitek's new indication approval solidifies BIC's strength, ASCENTAGE-B (06855) accelerates the potential of hematopoiesis.

As the first and globally best-in-class third-generation BCR-ABL inhibitor in China, Nylotinib, which was approved for listing in November 2021, fills the treatment gap for Chinese patients with T315I mutation after developing resistance. Since its launch two years ago, Nylotinib has been highly recognized by the international academic community for its innovative attributes with the best potential in its class worldwide. This year, several clinical advances in ASCENTAGE-B (06855) in research & development of new drugs were selected for oral presentations at the 65th Annual Meeting of the American Society of Hematology (ASH), including 2 Nylotinib-related studies. This marks the 6th consecutive year that this drug has been selected for oral presentations at the ASH annual meeting. While receiving strong support from the international academic community, Ascentage Pharma's stock price and market value in the secondary market have also soared. It is observed that from October to the present year, driven by positive developments in core product research and commercialization, Ascentage Pharma's stock price has experienced a significant upward trend. From October 5th to November 17th, the company's stock price reached its highest increase of 45.1%, and the highest intraday stock price reached HK$28, a new high since September this year. However, the current trend clearly has not reached its climax. On November 17th, Ascentage Pharma announced that Nylotinib had officially been approved for the treatment of adult patients with chronic phase (CP) chronic myeloid leukemia (CML) who are resistant and/or intolerant to first- and second-generation tyrosine kinase inhibitors (TKIs). The biggest highlight of this new indication approval for Nylotinib is the patient population size for the two approved indications. The number of TKI-resistant CML patients far exceeds the population with T315I mutations. This further guarantees a substantial increase in Nylotinib's sales revenue in the future and lays a solid foundation for Ascentage Pharma's future valuation ascent. Bring new treatment choices to a broader range of patients As an independently developed class 1 new drug of Ascentage Pharma, Nylotinib had previously received support from the national "Major New Drug Creation" special project and has the best global capabilities in its class. The indication for the treatment of chronic myeloid leukemia with T315I mutation resistance was approved in November 2021 and was included in the National Medical Insurance Catalog in January of the same year. This broke the long-standing treatment dilemma for Chinese patients with T315I mutation resistant CML and made the treatment affordable, filling the clinical treatment gap in China. Since its approval and market launch, Ascentage Pharma has been promoting the commercialization of Nylotinib while also exploring its treatment potential in broader indications. The successful approval of the indication for TKI-resistant CML is a typical example. It is understood that currently 20% to 40% of patients fail to respond to TKI treatment due to resistance or intolerance. The approval of Nylotinib for the treatment of chronic phase chronic myeloid leukemia patients resistant and/or intolerant to first- and second-generation TKIs will further break the resistance dilemma in the field of CML treatment. In this ASH annual meeting, one of Nylotinib's selected oral presentations is based on key Phase II clinical trial results that supported the approval of the above-mentioned indication. The upcoming clinical data to be presented by the company shows that in patients with TKI-resistant/non-tolerant chronic phase chronic myeloid leukemia, compared with the control group receiving the best available therapy (BAT), the Nylotinib treatment group significantly extended the median event-free survival (mEFS) from 2.86 months to 21.22 months, reducing the event risk by 65%. This study demonstrated significant improvement in both statistical and clinical terms in terms of event-free survival (EFS), achieving the primary endpoint of the study. This study further consolidates Nylotinib's dominance in the field of CML indications. In July 2022, the Center for Drug Evaluation (CDE) accepted the marketing application for this indication of Nylotinib and included it in the priority review process. With the approval of the new indication for Nylotinib to treat chronic phase CML patients resistant and/or intolerant to previous TKIs, Nylotinib is expected to achieve a new round of market growth. In addition, Ascentage Pharma has also found significant efficacy of Nylotinib in patients resistant to the third-generation BCR-ABL inhibitor ponatinib in clinical studies conducted in the United States. Therefore, the company is in further communication with the FDA to promote the registration and clinical approval of the product, aiming to launch in the United States as soon as possible and benefit more patients globally. Unveiling the value of the product, continuous fulfillment of hematopoietic potential As the company's first listed product and representative of a domestically developed major innovative drug, the first-mover advantage demonstrated by Nylotinib in the end market is an important guarantee for Ascentage Pharma's continued realization of its hematopoietic potential. Take the company's interim performance this year as an example. During the reporting period, Ascentage Pharma achieved a significant increase in revenue, with sales reaching RMB 143 million, a 49% increase compared to the same period last year. Behind the substantial increase in overall revenue is the significant increase in sales volume of Nylotinib after its inclusion in the new version of the National Medical Insurance Drug List in January of this year. In fact, looking at the results of previous medical insurance negotiations in past years, the level of innovation in drugs has continued to rise, and varieties with high clinical value have mostly achieved significant growth in sales after negotiating price reductions and entering the medical insurance system. Taking Nylotinib as an example, as a benchmark for innovative drugs mentioned in the medical insurance negotiation by the National Medical Insurance Bureau, Nylotinib achieved medical insurance coverage with a minimal price reduction, far exceeding industry expectations. Therefore, after being included in the new version of the National Medical Insurance Drug List in January this year, with the support of the medical insurance system, the company's interim report showed that sales of Nylotinib increased significantly, achieving sales revenue of RMB 108 million, a 37% increase compared to the same period last year. In the second quarter, sales increased by 153% year-on-year, and the number of units sold increased by 560%, further enhancing Ascentage Pharma's hematopoietic function. The biggest highlight of this new indication approval for Nylotinib is that from the perspective of indications, Nylotinib has changed from a "third-line drug" to a "quasi-second-line drug". Therefore, investors can refer to the sales of dasatinib, a second-generation BCR-ABL inhibitor, to make a new assessment of the future sales increment of Nylotinib. According to BSM's financial report, dasatinib achieved annual sales of USD 2.165 billion in 2022. It is worth mentioning that the CML market is only a corner of Nylotinib's commercialization map, and the product's potential for imagination in the future is not limited to this. In addition to CML, another growth point for Nylotinib comes from Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), which is currently under clinical research. (Translated by AI)Ph+ acute lymphoblastic leukemia (ALL).On May 31st, Yasheng Pharmaceuticals announced that Netilnic was included in the "Planned Breakthrough Therapeutic Varieties". Just over half a month later, the company announced again the results of Netilnic in the treatment of relapsed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) in children. At the 2023 European Hematology Association (EHA) Annual Meeting held this year, the latest clinical data of Netilnic in adult patients with Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) were presented in a poster presentation. At the same time, the clinical data of Netilnic in relapsed Ph+ ALL in children was published for the first time in an international journal, which also proves its significant therapeutic potential and good safety in the field of ALL. In terms of the market potential of this indication, a comparative report on cancer data between China and the United States released by the National Cancer Center last year showed that the estimated number of new leukemia cases in China in 2022 is nearly 90,000. It is reported that ALL accounts for about 10%-15% of all leukemias, and Ph+ ALL accounts for about 30% to 40% of adult ALL, with a large number of patients. In terms of market competition, currently ponatinib is conducting phase I/II clinical studies of TKI-resistant/recurrent Ph+ ALL in China. Combining its safety risks, ponatinib and Netilnic are difficult to directly compete in the first-line treatment market. Therefore, Netilnic has a strong certainty in winning the majority of market share in the domestic first-line treatment market of Ph+ ALL, and this indication will bring considerable market increment to Netilnic. Yasheng Pharmaceuticals is also transforming the sales potential of core products into the driving force for sales growth through further improvement of international production and quality management system. In terms of production and quality management system construction, after obtaining the drug production license (A certificate) last year, Yasheng Pharmaceuticals obtained the GMP (Good Manufacturing Practice) compliance audit report issued by the EU Qualified Person (QP) in April this year. The global industrial base of the company passed the EU QP audit with zero defects. This means that in the future, whether it is product delivery speed or listing progress, Yasheng has a solid foundation in production. It is not difficult to see that from CML to Ph+ ALL, and then to SDH-deficient GIST, Yasheng Pharmaceuticals has always focused on patients with unmet treatment needs in the development and expansion of Netilnic indications. Under this development concept, Yasheng Pharmaceuticals, which combines research and development, production, and commercialization, has a systematic competitive advantage. As a leading company with heavyweight commercialized products and both continuous hematopoiesis and differentiated innovation capabilities, it will also accelerate the realization of value and valuation rebound in the new upward cycle with its strong income conversion ability of innovative products and technologies.