Lupeng Pharmaceutical Achieves Dual Milestones: NMPA Approval for Rocbrutinib and Hong Kong IPO Filing

　　【Pharmaceutical Network - Corporate News] Recently, Lupeng Pharmaceutical announced that its self-developed Class 1 innovative drug, Luokeda® (lobutinib tablets, Rocbrutinib; development code: LP-168), has officially received marketing approval from the National Medical Products Administration (NMPA) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have previously received at least two systemic therapies (including BTK inhibitors).
 

Public information indicates that Lupeng Pharmaceutical is an innovative pharmaceutical company focused on oncology and autoimmune diseases, possessing its independently developed BeyondX oral drug chemistry platform. Currently, the company has established a product pipeline comprising six major candidate products, among which three core assets are in the New Drug Application (NDA) or clinical stages: the flagship products LP-168, LP-108, and LP-118.
 

The approval of Luokeda® validates the druggability of the company’s independently developed BeyondX oral drug chemistry platform. In the future, leveraging this technology platform to incubate more innovative pipelines will become the core driver of the company’s valuation growth. In fact, Lupeng Pharmaceutical had previously received IND approval from the National Medical Products Administration (NMPA) for the combination therapy of LP-168 and LP-108 in treating mature B-cell tumors. Furthermore, clinical studies of LP-168 for chronic spontaneous urticaria (CSU) have already been initiated, with plans to expand into major autoimmune indications, including immune thrombocytopenia (ITP), primary membranous nephropathy (pMN), multiple sclerosis (MS), and generalized myasthenia gravis (gMG).
 

It is worth noting that in August 2024, Hansoh Pharma entered into a collaboration agreement with Lupeng Pharmaceutical, securing the rights to develop, register, manufacture, and commercialize lobutinib for all non-oncology indications in China (including Hong Kong, Macao, and Taiwan), with a total transaction value exceeding RMB 700 million. This deal underscores its business development (BD) capabilities in out-licensing. As self-developed products come to market, the company’s focus is expected to shift toward building its commercialization team and securing market access, thereby gradually transitioning from a “R&D-driven” to a “commercialization-driven” model.
 

In addition to the approval and market launch of its innovative drugs, Lupeng Pharmaceutical has recently submitted a listing application to the Main Board of the Hong Kong Stock Exchange. The prospectus shows that Lupeng Pharmaceutical had no revenue in 2024, with revenue reaching RMB 32.07 million in 2025; the net losses for 2024 and 2025 were RMB 3.39 million and RMB 207 million, respectively.
 

Industry analysts believe that with the approval of lobutinib, the company urgently needs funds to advance subsequent commercial team building, market promotion, and clinical expansion for additional indications. Listing in Hong Kong is a strategic move to replenish its “ammunition.” It is reported that prior to the IPO, Lupeng Pharmaceutical had already conducted multiple rounds of financing, totaling $213 million.
 

In summary, Lupeng Pharmaceutical’s recent “double celebration” marks the convergence of “hardcore technology” and a viable capital pathway. It demonstrates that in the highly competitive oncology drug sector, only technologies that precisely address clinical pain points—such as overcoming drug resistance—can attract greater capital interest. Meanwhile, the commercialization of its products will provide a solid foundation for its subsequent IPO valuation.
 

Whether Lupeng Pharmaceutical can successfully penetrate the market with its flagship product, lobutinib, and sustain subsequent R&D investments across multiple indications will be a critical test in its transition to a mature pharmaceutical company.
 

　　Disclaimer: Under no circumstances shall the information contained herein or the opinions expressed constitute investment advice to any person.