On April 7, Beijing, Guangzhou, and Zhuhai published documents relating to “Supporting the High-Quality Development of Innovative Pharmaceuticals”. This is only 26 days since the March 13 “Draft for Comments on the Implementation Plan for Full-Chain Support to Support the Development of Innovative Drugs” document went out of the market. In other words, the domestic innovative drug sector felt the strength and warmth of “full chain support” on the policy side in less than a month, reflecting the determination of the regulatory authorities to vigorously develop the innovative drug industry.
On April 3 of this year, Yasheng Pharmaceutical was subscribed to a total of 230,000 shares, equivalent to HK$4.165,700 by Executive Director and Chairman of the Board of Directors Dr. Wang Shaomeng. On the evening of April 8, the company announced that Dr. Yang Dajun had an additional 80,000 shares, equivalent to HK$1.3662 million. Executives' holdings continued to increase by HK$5.53 million, which also reflects the company's management's confidence in the domestic innovative pharmaceutical industry and the future growth of Yasheng Pharmaceuticals.
With incentives from the policy side, the capital market reacted positively. On April 8, the innovative drug sector of Hong Kong stocks continued to rise in early trading. For example, individual stocks such as Corning Jerry Pharmaceutical-B, Connoa-B, Yasheng Pharmaceutical-B, and Genting Xinyao B all showed good gains. On April 9, Yasheng Pharmaceutical's stock price opened high and continued to rise. The highest increase in early trading was close to 7%.
It is easy to see that the introduction of relevant policies is undoubtedly a huge benefit for many innovative pharmaceutical companies, such as Yasheng Pharmaceutical, that have major commercial products, and are capable of continuous hematopoiesis and global innovation.
In fact, the core of the policy's “full chain support” for innovative drugs is support for new targets, new mechanisms, and the selection and support of key R&D catalogs of innovative drugs that can address unmet clinical needs and have clear clinical value.
This requires innovative pharmaceutical companies' hard-core innovation capabilities and original innovative drug product capabilities to stand the test of international academia and the global market.
Taking Yasheng Pharmaceutical-B (06855) as an example, on April 8, the company announced three preclinical research results at the 2024 American Association for Cancer Research (AACR) annual meeting, involving four important varieties of the company's original Class 1 drug olevatinib (trade name: Nelick), MDM2-p53 inhibitor APG-115, FAK/ALK/ROS1 triple tyrosine kinase inhibitor APG-2449, and embryonic ectodermal development protein (EED) inhibitor APG-5918.
According to the Zhitong Finance App, since the launch of the core product Nellick, Yasheng Pharmaceutical has achieved steady growth in performance with its advantages in filling clinical gaps domestically, while also relying on its strong global innovation capabilities to open up a wider application track for it. Currently, Nellick has good activity against various kinases including BCR-ABL, KIT, PDGFR, FGFR, b-RAF, DDR1, FLT3, etc., and has broad potential in the treatment of various solid tumors and hematological tumors.
In the field of solid tumors, Nellick has received CDE as a breakthrough treatment for patients with succinate dehydrogenase (SDH) -deficient gastrointestinal stromal tumors (GIST) who have previously undergone first-line treatment. Relevant clinical progress has been selected for the ASCO annual conference for 2 consecutive years. Data presented at last year's ASCO annual conference showed that olevatinib had remarkable efficacy and good safety in SDH deficient GIST patients with TKI resistance, and the clinical benefit rate (CBR) was as high as 93.8%. At this AACR annual meeting, Nellick once again demonstrated excellent anti-tumor effects in the field of SDH deficient tumor indications.
In fact, as a truly innovative drug, Nellick's excellent treatment performance in the field of SDH defective tumors is only the “tip of the iceberg” of its huge therapeutic potential.
On November 17 of last year, Nellick was officially approved to treat adult patients with chronic myeloid leukemia (CML) chronic phase (-CP) who are resistant and/or intolerant to first-generation and second-generation tyrosine kinase inhibitors (TKI). As far as Yasheng Pharmaceutical is concerned, compared to the previously approved indications for treatment with T315I mutant drug resistance CML, the group of patients with the newly approved indications is wider, further ensuring that Nellick's subsequent sales will continue to grow.
Outside of the CML field, Nellick's therapeutic and commercialization potential is also continuously being explored and verified. In the field of hematoma, Nellick's next growth point comes from Philly chromosome-positive (Ph+) acute lymphocytic leukemia (ALL).
In 2023, two recent clinical data from Nellick for adult Ph+ ALL patients were presented on the 2023 EHA Annual Meeting poster. Nellick's clinical data in children with recurrent Ph+ ALL was also published for the first time in an international journal. Clinical data shows that Nellick has significant therapeutic potential and good safety in the field of Ph+ ALL.
It is worth mentioning that in the “Full Chain Implementation Plan to Support the Development of Innovative Drugs (Draft for Comments)” that was previously circulating in the market, it was mentioned that by 2027, more than 10 first in Class (First in Class) drugs will be marketed, and more than 10 innovative drugs will be registered and marketed overseas.
With the full chain support from the policy side, Yasheng Pharmaceutical will become one of the largest beneficiary pharmaceutical companies in China. The company has always been committed to original innovation and global innovation. Currently, it is carrying out more than 40 clinical trials in China, the United States, Australia, Europe and Canada. Clinical progress related to research varieties such as APG-115, APG-2449, APG-1387 and APG-1252 has been published in several authoritative international academic conferences and journals. Furthermore, the company has built a strong global intellectual property layout through 498 authorized patents worldwide.
In terms of products, Nellick is expected to become one of the models for domestic FIC/BIC innovative drugs going overseas.
In February of this year, Nellick's registered phase III trial for CML-CP (with and without T315I mutation) patients who have been treated in the past was approved by the US FDA. This is the first Nellick Global Registration Phase III trial approved by the US FDA. In addition, Nellick was also included in the latest edition of the US National Comprehensive Cancer Network (NCCN) CML treatment guidelines, showing great potential to compete in the international market.
In fact, Yasheng Pharmaceutical is not the only core product of Nellick. Last year, the Bcl-2 inhibitor APG-2575, the core product of the company's apoptosis pipeline, was also approved for global Phase III clinical registration. A number of previous clinical data have also verified that APG-2575 has “best-in-class” (best-in-class) potential in the field of global hematologic oncology. This means that APG-2575 is expected to accelerate to become the second Bcl-2 inhibitor approved for marketing at the global level.
The “Beijing Municipal Measures to Support the High-Quality Development of Innovative Pharmaceuticals (2024) (Draft for Comments)” mentions that “the entire chain will support the development of the innovative pharmaceutical industry from the clinical research side, review side, import and export trade side, payment side, data side, and investment and financing side.” The document also stated that “IND approval time will be reduced from 60 days to 30 days, the review time for drug supplement applications will be reduced from 200 days to 60 days, project management will be implemented for innovative drugs, early intervention and full guidance, etc. In 2024, we will strive to open up 10 imported varieties and promote the export of 5 varieties at the same time.” This is clearly a major boon for the field of innovative medicines.
In addition to Nellick and APG-2575, another important layout of Yasheng Pharmaceuticals in the field of hematoma is the MDM2-p53 inhibitor APG-115, which was unveiled at the AACR annual conference. As the first MDM2-p53 inhibitor to enter the clinical stage in China and a potential first-in-class new drug developed in China, Yasheng Pharmaceutical is conducting multiple clinical studies in China, the US, and Australia to treat solid tumors and hematological tumors as a single drug or combination of APG-115 drugs.
At the same time, the EED inhibitor APG-5918 and the small-molecule FAK/ALK/ROS1 multi-target kinase inhibitor APG-2449, which are being developed at an accelerated pace, are also continuously demonstrating the company's global FIC/BIC potential in solid tumor/hematoma research and development.
At present, with the release of the potential of core products such as Nellick and APG-2575 in innovative R&D and commercialization, Yasheng Pharmaceutical has now built a good foundation in the global field of innovative drugs. In the future, as multiple pipelines such as APG-115, APG-5918, and APG-2449 advance steadily, Yasheng Pharmaceutical's hard-core innovation capabilities are expected to continue to be recognized by the market and the international academic community, and the company's position in the hematoma/solid tumor market will continue to move forward.