CITIC SEC: Maintains Outperform the Market Rating for Innovative Drug Industry and lays out three main investment lines.
CITIC Securities released a research report stating that WCLC and ESMO will jointly form an important and intensive clinical value verification window for innovative drugs in China in the second half of the year, which is expected to accelerate the global development of core assets.
CITIC SEC released a research report stating that WCLC and ESMO will jointly constitute an important and intensive clinical value validation window for innovative drugs in China in the second half of the year, which is expected to accelerate the global development of core assets. They maintain a "stronger than the market" rating for the innovative drug industry and suggest positioning along three main lines: 1) assets with clear conference catalysts, currently in critical proof of concept (PoC) or evidence deepening stages; 2) antibody-drug conjugates (ADC) with phase III evidence or relatively high certainty of global development; 3) second-generation immuno-oncology (IO) and other differentiated mechanism assets in global validation or indication expansion stages.
CITIC SEC's main points are as follows:
WCLC: RAS, second-generation IO, and ADC form three high-attention main lines.
According to the WCLC conference official website:
RAS: GFH375 (VS-7375), developed by the joint efforts of Jiahong Pharma and Verastem Oncology, will update phase I/II data on KRAS G12D mutation late-stage NSCLC; Qilu Pharmaceutical's QLC1101 will disclose phase I data on the same target; HANSOH PHARMA's HS-10370, in combination with Jiangsu Hengrui Pharmaceuticals' ad bear monoclonal antibody and chemotherapy, explores first-line treatment for KRAS G12C mutation late-stage NSCLC.
Second-generation IO: WELLYBIO LBL-024 combined with chemotherapy, JUNSHI BIO JS207 combined with chemotherapy, and REMEGEN RC148 (ABBV-1480) combined with chemotherapy cover first-line advanced NSCLC, unresectable stage III NSCLC, and first-line locally advanced or metastatic NSCLC, respectively. Both RC148 and JS207 are PD-1VEGF bispecific antibodies, with RC148 being one of the first significant PoC readouts for lung cancer after AbbVie obtained exclusive rights outside Greater China.
ADC: The wholly-owned subsidiary of Sichuan Biokin Pharmaceutical, SystImmune, in collaboration with Bristol Myers Squibb, will disclose phase I randomized dosing/scheme expansion of izalontamab brengitecan (iza-bren, BL-B01D1) in metastatic EGFR mutant NSCLC. CSPC PHARMA SYS6010 combined with enfortumab vedotin will disclose phase II data. Yilian Bio's YL201 combined with HENLIUS's surufatinib is a phase I study; Qilu Pharmaceutical's QLC5508 (MHB088C), a product developed by Minghui Pharmaceutical with rights in Greater China, combined with QL1706 or QL2107 is a phase II study for extensive stage SCLC.
New mechanisms: LB2102, co-developed by Legend Biotech and Novartis with global exclusive rights, is a dnTGFBR2 armored DLL3-targeted autologous CAR-T, currently in phase I, targeting relapsed/refractory SCLC or large cell neuroendocrine carcinoma.
ESMO: Phase III data solidify clinical value, and multi-level PoC opens flexible space.
Phase III data solidify clinical value: Focus on long-term survival, head-to-head results, and registration pathways.
SKB BIO's sac-TMT (SKB264/MK-2870) will disclose the final overall survival (OS) update for OptiTROP-Breast01 in treated locally recurrent or metastatic triple-negative breast cancer (TNBC) III phase; HENLIUS's STRIDE U.S. phase III bridging study will conduct a head-to-head comparison of surufatinib combined with chemotherapy in treatment-naive ES-SCLC patients. HANSOH PHARMA's dacomitinib combined with amivantamab will be compared to platinum-based chemotherapy for advanced NSCLC with MET amplification after EGFR-TKI treatment, which has already been accepted for NDA in China before the conference. Qilu Pharmaceutical's QL1706 combined with chemotherapy, with or without bevacizumab, will disclose first-line randomized phase III results for persistent, recurrent, or metastatic cervical cancer; Jiangsu Hengrui Pharmaceuticals' carrelizumab-related UNION study will update neoadjuvant randomized phase III data for locally advanced rectal cancer.
First clinical PoC of the drug: Validate the druggability and preliminary anti-tumor activity of new molecules.
GFH276 from Jiahong Pharma is a Pan-RAS(ON) inhibitor and has received qualification for LBA submission. If the LBA is ultimately accepted, it will be the first time this product's clinical data is disclosed at an international academic conference. INNOVENT BIO IBi3001 and HANSOH PHARMA HS-20122 are ADCs targeting EGFRB7-H3 and EGFRc-MET, respectively. The former will disclose phase I clinical data across multiple regions for the first time at an international academic conference, while the latter is expected to disclose human PoC for the first time. BeOne Medicines Ltd. BGB-58067 is an MTA co-inhibitor of PRMT5, expected to preliminarily validate its activity and safety window in MTAP-deficient tumors through first human phase I data.
Combined scheme PoC: Solidify clinical evidence; first combinations to validate clinical increment and joint safety window.
GFH375 from Jiahong Pharma, in combination with cetuximab, will validate clinical synergy between KRAS G12D inhibition and EGFR blocking, currently having obtained complete LBA submission qualification. INNOVENT BIO IBi363 (TAK-928) combined with bevacizumab will compare docetaxel in locally advanced or metastatic lung adenocarcinoma without targetable genetic changes and/or prior immunotherapy resistance, marking the first randomized controlled PoC for this combination scheme in this specific treatment scenario. DB-1311 (BNT324) co-developed by Yingen Bio and BioNTech will combine the previously developed pumitamig with results from the global phase II initial disclosure, examining the preliminary efficacy and toxicity overlap of B7-H3 ADC with PD-L1VEGF-A bispecific antibody. SBP GROUP TQB2102 will combine bemarituzumab, with or without capecitabine, which will disclose phase II results for that combination in first-line HER2-positive advanced gastric or gastroesophageal junction cancer.
New treatment scenario PoC: Examine the extension of the product and value after resistance sequelae.
9MW2821 from Maiwei Bio will disclose phase II results in locally advanced or metastatic TNBC previously treated with Topo I loaded ADC. AKESO's evorpacept will disclose phase Ib/II and II phase results in first-line IMDC-good prognosis advanced renal cell carcinoma (RCC) and relapsed or metastatic thymic carcinoma, representing the first PoC for evorpacept's expansion into new tumor types and new treatment scenarios.
Existing PoC deepening: Focus on dose optimization, durability of efficacy, and replicability of evidence.
WELLYBIO LBL-034 revealed RRMM clinical data at ASH, focusing this time on observing deeper response data under longer follow-up. CStone Pharmaceuticals CS2009 previously disclosed clinical signals in mCRC and NSCLC, with this round of two fast-track oral reports primarily aimed at expanding the sample size and improving data maturity. BeOne Medicines Ltd. BGB-B2033 previously disclosed initial HCC data at ASCO, with this Rapid Oral updating the results of dose escalation and optimization. Haisco Pharmaceutical Group HSK41959 also previously disclosed first human data at ASCO; this Poster primarily aims to update the cohort, PK/PD, and preliminary efficacy.
Risk factors: Clinical data may not meet expectations; early signals cannot be reproduced in expanded sampling or randomized studies; safety impacts dosage, joint development, or registration; global enrollment, BD, and commercialization may be slower than expected; competition for the same targets, industry policies, intellectual property, and international risks.
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