**Breaking News!  China’s Cancer Drug Outperforms Global PD-1 Inhibitor!**

**Breaking News!  China’s Cancer Drug Outperforms Global PD-1 Inhibitor!**

PD1

#AK112 #CancerDrug #PD-1 #PD1Inhibitor #CancerTreatment #BispecificAntibody #NSCLC

China’s pharmaceutical industry has reached a historic milestone! Remember AK112 (Ivonescimab), which took center stage during this year’s ASCO conference, attracting global attention for its groundbreaking potential? The long wait is finally over, and the results are in!

In May, Akeso Biopharma, a leading Chinese pharmaceutical company, announced that its independently developed bispecific antibody drug AK112 achieved a major milestone in clinical trials. AK112 demonstrated superior efficacy to the globally renowned PD-1 inhibitor Keytruda (K Drug) in treating PD-L1-positive non-small cell lung cancer (NSCLC), marking a revolutionary breakthrough for China’s innovative cancer treatments.

**Clinical Data that Surprised the World**

During the World Conference on Lung Cancer 2024, Professor Zhou Caicun, one of China’s top lung cancer experts, revealed the results of the HARMONi-2 study, which had the entire audience applauding. The data exceeded expectations, demonstrating that AK112 is not just on par with but superior to international “superstar” cancer drugs in several key areas.

– **Progression-Free Survival (PFS):** AK112 improved PFS by an astonishing 91.4% compared to Keytruda, reaching 11.14 months versus 5.82 months.

– **Risk Reduction:** AK112 reduced the risk of disease progression or death by 49%.

– **Objective Response Rate (ORR):** AK112 outperformed Keytruda with a response rate of 50.0% compared to 38.5%.

– **Disease Control Rate (DCR):** AK112 maintained a significant advantage, achieving 89.9% versus 70.5%.

While AK112 showed slightly higher Grade 3 side effects due to its VEGF inhibition, its overall performance remains remarkable. Although overall survival (OS) data is still maturing, AK112’s impressive PFS results suggest that its survival benefits will likely be just as extraordinary.

**The Power of Bispecific Antibodies**

AK112 is part of a new class of cancer drugs called bispecific antibodies, capable of targeting two different antigens at once. In this case, AK112 targets both PD-1 and VEGF, two well-known lung cancer markers. This dual-target approach offers patients better therapeutic options and increased convenience, potentially replacing the traditional combination of PD-1 inhibitors with anti-angiogenic drugs like Avastin.

This breakthrough has made AK112 the first and only bispecific antibody drug to outperform Keytruda in head-to-head clinical trials, solidifying its place as a future game-changer in cancer treatment.

**A Milestone for China’s Pharma Industry**

In May 2024, AK112 received regulatory approval from China’s National Medical Products Administration (NMPA) for treating EGFR-mutated, locally advanced, or metastatic NSCLC, becoming the world’s first approved PD-1/VEGF bispecific antibody.

This marks a monumental achievement for China’s pharmaceutical innovation. AK112’s success demonstrates that Chinese researchers and drug developers, in just two decades, have achieved what took developed nations over a century. China’s presence at top-tier global cancer conferences like ASCO and ESMO has never been stronger, with clinical data that leaves the world in awe.

China’s pharmaceutical industry may have started late, but its rapid progress is a testament to the ingenuity and hard work of its researchers. Once relying on generics, China is now a leader in pharmaceutical innovation, offering cutting-edge treatments to patients around the globe. The future of cancer treatment is here, and it’s painted in the bold color of “China Red.”

🎉🎉To assess whether the condition is suitable for CAR-T or clinic therapy, you can submit Advanced Medicine in China  for preliminary evaluation!

WhatsApp: +8613717959070

Https://wa.me/+8613717959070

Email: doctor.huang@globecancer.com

#CancerTreatment #MedicalInnovation #PharmaBreakthrough #ChinaPharma #AK112 #LungCancer #BispecificAntibody #PD1Inhibitor #GlobalHealth #MedicalAdvancements #ProudlyMadeInChina #WorldClass

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2 months ago Solid tumor

Breaking Ground: The First Nectin-4 Targeted ADC Approved in China – Urothelial Carcinoma

**Breaking Ground: The First Nectin-4 Targeted ADC Approved in China**

Urothelial Carcinoma

#UrothelialCarcinoma #Nectin4 #ADC

On August 19, the National Medical Products Administration (NMPA) of China officially approved the innovative antibody-drug conjugate (ADC), Enfortumab Vedotin, developed by Astellas and Pfizer. This groundbreaking approval marks the first Nectin-4 targeted ADC to receive approval in China, providing a new treatment option for patients with locally advanced or metastatic urothelial carcinoma who have previously undergone treatment with PD-1/PD-L1 inhibitors and platinum-based chemotherapy.

**Pioneering Nectin-4 Targeting**

Nectin-4, a protein found on the surface of cells, is highly expressed in bladder cancer. Enfortumab Vedotin, co-developed by Astellas and Seagen (a Pfizer subsidiary), is a first-in-class ADC that directly targets Nectin-4. By binding to cells expressing this protein, the drug delivers the potent anti-tumor agent monomethyl auristatin E (MMAE) into the cells, halting cell proliferation and inducing programmed cell death.

This ADC had already secured approvals in the United States, Japan, and the European Union for treating urothelial carcinoma. Now, with its approval in China, Enfortumab Vedotin stands as a beacon of hope for Chinese patients battling this challenging form of cancer.

**Clinical Evidence from China: The EV-203 Study**

The approval in China was based on data from the EV-203 study (NCT04995419), a phase II, single-arm, open-label, multi-center clinical trial conducted in China. The trial assessed the efficacy, safety, and pharmacokinetics of Enfortumab Vedotin in Chinese patients with locally advanced or metastatic urothelial carcinoma who had been treated with PD-1/PD-L1 inhibitors and platinum-based chemotherapy.

The study enrolled 40 Chinese patients, with the primary endpoint being the independent review committee (IRC) confirmed objective response rate (ORR). Results presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting revealed:

– An IRC-confirmed ORR of 37.5%, including one complete response (2.5%) and 14 partial responses (35.0%).

– A disease control rate (DCR) of 82.5% as per investigator assessment and 72.5% as per IRC evaluation.

– Median progression-free survival (PFS) was 4.24 months according to investigators and 4.67 months per IRC assessment.

– Median overall survival (OS) had not been reached at the time of analysis, with a median follow-up of 6.5 months.

The safety profile was manageable, with most treatment-related adverse events (TRAEs) being grade 1-2. These results underscore Enfortumab Vedotin’s meaningful clinical activity and a favorable benefit-risk profile in this patient population.

**Looking Ahead: Expanding Treatment Options**

Astellas is also progressing with a second indication for Enfortumab Vedotin in China. In March 2024, the company submitted an application for its use in combination with the PD-1 inhibitor pembrolizumab as a first-line treatment for adults with locally advanced or metastatic urothelial carcinoma who have not previously received treatment. Insight data predicts that this application could be approved as early as the third quarter of 2025.

Beyond Enfortumab Vedotin, there are over a dozen Nectin-4 targeted ADC projects under development in China. Among them, the most advanced is 9MW2821 from Mabwell, currently in phase III trials for urothelial carcinoma. Other promising candidates include SHR-A2102 from Hengrui, SYS6002 from CSPC, SKB410 from Kelun-Biotech, ADRX-0706 from Dizal/Adcentrx, and BAT8007 from Bio-Thera, all of which have entered clinical stages.

To assess whether the condition is suitable for CAR-T or clinic therapy, you can submit Advanced Medicine in China for preliminary evaluation!

WhatsApp: +8613717959070

Email: doctor.huang@globecancer.com

**#Nectin4ADC #CancerResearch #UrothelialCarcinoma #InnovativeMedicine #ChinaPharma #EnfortumabVedotin #ADC #PD1 #PDL1 #NEctin4