Industrial Securities Initiates Coverage on KEYMED BIO-B with 'Buy' Rating, Citing Pipeline Value Reassessment

Stock News05-18

Industrial Securities Co.,Ltd. has released a research report initiating coverage on KEYMED BIO-B (02162), assigning a "Buy" rating. The report highlights that the commercialization of CM310 has entered a phase of accelerated volume growth, while the value of other pipelines is being progressively validated. The company's robust in-house R&D platform is expected to continue delivering differentiated early-stage pipelines. The firm forecasts revenues for 2026 to 2028 to be RMB 2.70 billion, RMB 2.161 billion, and RMB 3.266 billion, respectively. Net profit attributable to shareholders is projected at RMB 570 million, a loss of RMB 242 million, and a profit of RMB 127 million for the same periods.

Key points from Industrial Securities' analysis are as follows:

Dual Drivers: External Partnerships and Commercial Sales Boost Revenue Generation The core product, Kangyueda (CM310), has seen significant sales expansion following its inclusion in the national reimbursement drug list (NRDL), achieving sales revenue of approximately RMB 310 million in 2025, a year-on-year increase of 775%. Revenue from external partnerships reached about RMB 410 million in 2025, primarily from collaboration projects involving CM313, CM355, CM512/CM536, and CM336. This includes equity income valued at approximately RMB 130 million from Newco. The company maintains ample cash reserves, with cash and short-term bank wealth management products totaling RMB 1.96 billion as of December 31, 2025.

Commercial Launch Year: Multi-Dimensional Efforts to Accelerate CM310 Uptake CM310 is China's first approved IL-4Rα antibody, granting it a first-mover advantage. It has secured approval for three indications in China: moderate-to-severe atopic dermatitis in adults, chronic rhinosinusitis with nasal polyps, and seasonal allergic rhinitis (exclusive). Both vial and pre-filled auto-injector presentations for all three indications have been included in the NRDL, effective January 1, 2026, which is expected to drive rapid market penetration.

Gilead Acquisition Bolsters Prospects for CM336 In March 2026, Gilead Sciences acquired Ouro Medicines, obtaining global rights (excluding Greater China) for CM336, a BCMA/CD3 bispecific antibody. KEYMED BIO-B is set to receive an upfront payment of approximately $250 million, along with up to $70 million in milestone payments. Gilead will also be responsible for potential additional milestone payments totaling up to $610 million and tiered royalties on net sales. This acquisition is anticipated to accelerate the global development of CM336 for autoimmune indications and serves as validation for the company's proprietary TCE R&D platform.

Multiple Key R&D Milestones Anticipated in 2026 CMG901 (CLDN18.2 ADC) is expected to report global Phase III data for second-line and later gastric cancer in the first half of 2026, with a Biologics License Application (BLA) submission planned for the second half. CM512 (TSLP/IL13 bispecific antibody) is slated to release Chinese Phase II data for chronic rhinosinusitis with nasal polyps in H1 2026, followed by the initiation of a Phase III trial in H2 2026. Chinese Phase I data for CM518D1 (CDH17 ADC) will be presented at the ESMOGI conference. Additionally, Investigational New Drug (IND) applications are expected for several first-in-class pipelines, including long-acting bispecific antibodies, bispecific ADCs, siRNA, and Protac molecules.

Risk Factors: Commercial performance may fall short of expectations; pipeline clinical progress or data may disappoint; industry policy adjustments could pose challenges.

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