Boehringer Ingelheim, Johnson & Johnson, and Other Multinational Pharma Companies Achieve New Milestones for Innovative Drugs in China

　　【Pharmaceutical Network Industry Dynamics】Recently, innovative drugs from several multinational pharmaceutical companies, including Boehringer Ingelheim and Johnson & Johnson, have made new progress in China. These innovative drugs will provide Chinese patients with more treatment options.
 

According to the public announcement on the website of the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA), Boehringer Ingelheim's innovative rare disease drug Namiseter Tablets (BI 1015550 Tablets) is proposed to be included in the priority review category, with the proposed indication being Idiopathic Pulmonary Fibrosis (IPF). The announcement period is from February 28, 2025, to March 7, 2025.
 

Data show that Namistat is a novel PDE4B inhibitor under development by Boehringer Ingelheim. It exerts its effects by inhibiting the PDE4B enzyme, which is highly expressed in the lungs and closely associated with fibrotic and inflammatory processes. By inhibiting these pathways, Namistat demonstrates dual anti-fibrotic and anti-inflammatory effects, offering potential clinical benefits for patients with IPF. In 2022, the U.S. FDA granted this product Breakthrough Therapy designation, highlighting its potential in the treatment of IPF.
 

Recently, Johnson & Johnson announced that Tremfya Duo (Guselkumab Injection (Intravenous Infusion)) and Tremfya (Guselkumab Injection) have been approved in China for the treatment of adult patients with moderate to severe active Crohn's disease who have had an inadequate response, lost response, or were intolerant to conventional therapy or biologics. This accelerated approval marks the world's first approval of Guselkumab for the indication of Crohn's disease.
 

It is reported that this approval was based on the clinical data from two pivotal Phase III studies (GALAXI 2 and GALAXI 3) of the GALAXI program. In the trials, both dose regimens of guselkumab successfully achieved the co-primary endpoints. Firstly, compared with placebo, they demonstrated statistically significant and clinically meaningful clinical and endoscopic outcomes. Secondly, based on the pooled results of the two studies, they showed superiority over Stelara® (ustekinumab) in multiplicity-controlled endoscopic endpoints. The two dose regimens in the trial were: 200 mg intravenous induction (at weeks 0, 4, and 8) followed by either 100 mg subcutaneous maintenance every 8 weeks or 200 mg subcutaneous maintenance every 4 weeks.
 

In addition, recently, according to the website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China, Pfizer's (PFE.US) Class 1 new drug PF-07934040 tablets have obtained clinical trial tacit approval, intended for development to treat advanced solid tumors carrying KRAS mutations.
 

According to publicly available information from Pfizer, PF-07934040 is a pan-KRAS "ON/OFF" inhibitor with activity against wild-type (wt) KRAS and major mutant subtypes, but no activity against NRAS or HRAS. PF-07934040 demonstrates binding to both the OFF (GDP-bound) and ON (GTP-loaded) states of KRAS wt, with very low binding affinity to mutants, and its selectivity for KRAS is 5000 times higher than that for HRAS/NRAS.
 

Studies show that PF-07934040 blocks the binding of RAF-RBD to KRAS mutants loaded with GTPgS, indicating that its mechanism of action may include binding to the KRAS on state and inhibiting RAF binding to modulate downstream signaling. According to publicly available information, this is the first time the product has been approved for IND in China. The clinical approval of PF-07934040 in China means that the product is about to begin clinical research in China.
 

CDE website recently announced that MSD's Class 1 new drug, MK-6070 for injection, has also received implied permission for clinical trials, intended for the development of treatment for small cell lung cancer. This means that this investigational new drug will enter the clinical research stage in China.
 

It is reported that as an investigational new drug, the clinical progress of MK-6070 has drawn significant attention because it is a tri-specific antibody targeting CD3/DLL3/Albumin. Additionally, following Pembrolizumab, MK-6070 may also represent Merck's new endeavor in the oncology field. However, overall, the development of MK-6070 in China is still at a very early stage, with considerable uncertainty ahead.
 

The CDE website also announced that the Class 1 new drug deucrictibant extended-release tablets, submitted by Pharvaris, have received implied permission for clinical trials, with the proposed indication being hereditary angioedema. Data shows that this is a potent and selective oral antagonist of the bradykinin B2 receptor, currently undergoing Phase 3 clinical trials internationally. According to publicly available information, this is its first IND approval in China.
 

China is a global large - scale pharmaceuticals and healthcare market. The entry of innovative drugs from multinational pharmaceutical companies into China allows their products to access a vast market, increasing sales and profits, enhancing market and brand awareness, and providing momentum for the growth of their global business. Meanwhile, multinational pharmaceutical companies deepening their strategic layout in China also reflects their emphasis on the Chinese market. Moreover, the approval of innovative drugs from multinational pharmaceutical companies in China will also enable Chinese patients to access cutting - edge international drugs more quickly, allowing them to benefit synchronously or nearly synchronously with patients worldwide, reducing waiting time, and improving the overall medical standards and quality of life.
 

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