Differentiated innovation pipeline is about to harvest, now may be the best opportunity to buy IMMUNEONCO-B (01541).

After three years of deep correction, the overall valuation of the Hong Kong stock pharmaceutical sector is currently at a historical low, severely depressing the valuation and liquidity of companies within the sector. The Federal Reserve's decision to cut interest rates in September is set in stone and will bring much-anticipated liquidity to the Hong Kong biopharmaceutical sector. At the same time, it has been observed that IMMUNEONCO-B (01541) recently experienced significant fluctuations in stock price due to the expiration of the pre-IPO shareholder lock-up period. The company had just completed external authorizations worth over $2 billion in early August. The clinical data of the core product IMM01 also received a warm response from the academic community at this year's ASCO annual meeting. The performance of the stock price clearly deviates from the fundamentals, posing an awkward situation for 18A companies in the Hong Kong stock market after the lifting of restrictions in the past one to two years. Shareholders do not deny the value of the company, but due to various reasons such as fund maturity and LP selling pressure, coupled with a lack of liquidity, the stock price experiences drastic fluctuations post-restriction. However, the drop in prices also provides a great opportunity for investors focusing on its long-term value. On the evening of September 8th Beijing time, AKESO announced at the World Lung Cancer Congress the phase III data of Ivvosidunab (PD-1/VEGF bispecific antibody) monotherapy in the first-line treatment of PD-L1-positive NSCLC, showing a significantly longer mPFS of 11.14 months compared to 5.82 months with pembrolizumab alone. The risk of disease progression or death was reduced by 49% compared to pembrolizumab alone, with a PFS HR of 0.51 (P <0.0001). ORR, DCR, and subgroup analysis data all showed excellent results, bringing greater potential to the field of tumor immunotherapy with PD-1/VEGF bispecific antibodies. In August, Aike Mingang's similar target molecules IMM2510 (VEGFxPD-L1 mAb-Trap) and IMM27M (CTLA-4, ADCC+) reached a BD cooperation agreement totaling over $2 billion with Instil Bio, Inc (TIL.US), a wholly-owned subsidiary of SynBioTx Inc. IMM2510 utilizes a single monoclonal antibody-receptor recombinant protein structure (mAb-Trap), adding engineered VEGFR1-D2 to the N-terminus of the heavy chain of the PD-L1 antibody. Each target is bivalent, ensuring the activity of the PD-L1 target while retaining the function of the Fc, and further strengthening the ADCC effect mediated by the Fc through genetic engineering technology. Results of the phase I monotherapy escalation trial showed that out of 25 evaluable patients, 3 patients achieved partial responses (3PR), 7 patients had stable disease (7 SD), with 4 cases showing tumor shrinkage exceeding 15%. Particularly in areas with huge market potential such as non-small cell lung cancer and gynecological tumors, it demonstrated excellent efficacy signals. The indication for phase II monotherapy treatment of soft tissue sarcomas is currently enrolling. IMM27M is a new generation CTLA-4 monoclonal antibody that has been redesigned using genetic engineering technology to enhance the ADCC effect of the Fc segment, showing stronger tumor suppression activity in vitro and in vivo compared to marketed product ipilimumab. Preliminary data from the phase I escalation trial of IMM27M showed positive efficacy signals in various solid tumors, including breast cancer, with no dose-limiting toxicities (DLT) observed at the highest dose level. Aike Mingan Science is one of the few innovative drug companies with pipelines targeting PD-(L)1, VEGF, and CTLA-4. These three targets have been clinically validated and the drug characteristics are unquestionable, with the possibility of showing enormous potential in terms of efficacy when used together. In late August, Aike Mingan Science received an upfront payment from its partner and established a joint clinical research committee with the partner, currently accelerating the exploration of indications in solid tumors, especially in large market spaces such as non-small cell lung cancer, liver cancer, kidney cancer, and triple-negative breast cancer. In fact, the external cooperation of IMM2510 and IMM27M is just a stage result in the innovative research and development process of Aike Mingan Science. The core product of Aike Mingan Science, known to the capital market, is SIRP-Fc fusion protein targeting CD47 (IMM01). Through differentiated molecular design, SIRP-Fc achieves a perfect balance between efficacy and safety. In vitro studies have shown that it does not bind to human red blood cells and fully activates macrophages through a dual mechanism, interfering with the CD47/SIRP interaction to block the "don't eat me" signal and delivering the "eat me" signal through the activation of Fc receptors on macrophages. At the ASCO conference in June, two phase II studies of SIRP-Fc were selected for oral presentations, receiving enthusiastic responses due to their outstanding efficacy and safety data. At the ESMO conference in September, two phase II data will also be presented orally. It is understood that three indications for SIRP-Fc have received approval for phase III pivotal clinical trials, including the treatment of relapsed classical Hodgkin's lymphoma (cHL) with rituximab after the failure of prior PD-1 antibody treatment, which began enrolling patients in July. Interim data analysis is expected by the end of 2025, and based on the performance of the interim analysis, conditional marketing approval may be sought. Phase III trials for chronic myelomonocytic leukemia (CMML) are also underway. Currently, we are in a critical period of breaking the ice in the global biotechnology capital winter. Companies and products with true intrinsic innovation are expected to receive more attention from the market and the industry. The BD exceeding $2 billion indirectly confirms the ability of Aike Mingan Science's integrated self-owned research platform in globalized innovative research and development, laying a solid foundation for the company's future development. The cash flow generated from this BD cooperation will further supplement Aike Mingan Science's cash reserves, rapidly propel the clinical progress of key projects, and realize the value of innovative research and development. As a fully self-researched innovative drug research platform company, Aike Mingan Science not only has a rich pipeline in tumor immunotherapy but also has early layouts in the fields of metabolism and autoimmunity. The IND applications for Amulirafusp alpha (IMM0306, CD47x CD20 mAb-Trap) have already been approved for two indications in June this year. The ActRIIA target product is about to apply for IND for pulmonary arterial hypertension and muscle building and fat reduction.For an innovative biopharmaceutical company, continuous innovation and progress are the core elements to stay ahead. In the future, with the liquidity of the healthcare sector on the Hong Kong stock market recovering, the continuous implementation of the company's own innovative pipeline, and the possibility of more external licensing collaborations, the investment value of Amgen will no doubt receive positive feedback from the capital market.