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China Drug Approvals | 2023 | NMPA Drug Approvals | Pharma | Healthcare | China | iPharmaCenter

December 21, 2023

Takeda's Livtencity was approved in China for CMV infections 

Takeda declares the approval from China NMPA for Livtencity (maribavir), approved for treating adults facing post-transplant cytomegalovirus (CMV) unresponsive to prior therapies. Livtencity, the sole inhibitor of CMV-specific UL97 Protein Kinase authorized in China for addressing post-transplant CMV infection/disease resistant to standard anti-CMV intervention.


Approval stems from Phase 3 TAK-620-303 SOLSTICE Investigation, showcasing maribavir's superiority over traditional therapies at Week 8, for the primary endpoint. CMV represents a frequent and severe post-transplant ailment, leading to other grave infections, loss of transplanted organs, and graft failure. Takeda today reveals the approval of Livtencity (maribavir) by China's National Medical Products Administration (NMPA) for managing adults with post-hematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT) CMV infection/disease resistant to treatment (with or without genotypic resistance) using ganciclovir, valganciclovir, cidofovir, or foscarnet. 


Livtencity stands as the exclusive CMV-specific UL97 protein kinase inhibitor in China for this purpose. China Center for Drug Evaluation (CDE) awarded Breakthrough Therapy Designation to Livtencity in 2021.


NMPA's endorsement is founded on the outcomes of the Phase 3 SOLSTICE trial, scrutinizing maribavir versus standard antiviral approaches – ganciclovir, valganciclovir, cidofovir, or foscarnet – for addressing CMV infection/disease resistant to earlier treatments. In SOLSTICE, Livtencity outperformed conventional therapies at Week 8 for the primary endpoint of confirmed CMV viremia clearance in post-transplant adults with resistant CMV infection.


NMPA's approval signifies the twelfth nod for Livtencity worldwide for post-transplant CMV resistant to previous therapies, covering other significant markets like the United States, Canada, Australia, and the European Union.


Among the approximately 200,000 annual adult transplants globally, CMV emerges as a frequent infection, with an estimated incidence rate of 16%-56% in SOT and 30%-80% in HSCT recipients.

 

China's National Medical Products Administration (NMPA) has accepted Astellas Pharma's Xtandi (enzalutamide) New Drug Application (NDA) based on compelling clinical trial results.

In the Phase 3 China ARCHES study, 180 Chinese mHSPC patients were divided into two groups. One received Xtandi alongside androgen deprivation therapy (ADT), while the other received a placebo combined with ADT. Xtandi met the study's primary endpoint, a significant improvement in time to prostate-specific antigen (PSA) progression (TTPP). These results mirrored findings from Astellas' global Phase 3 ARCHES study in the same patient population, providing strong support for Xtandi's efficacy.

Notably, the safety profile of Xtandi plus ADT in the China ARCHES study remained consistent with the medication's well-established safety record.

While Xtandi has not yet received NMPA approval for mHSPC treatment in China, the promising clinical trial outcomes suggest that a powerful new therapy may soon be available to combat this aggressive form of prostate cancer.

Calquence (acalabrutinib), a medication developed by AstraZeneca received approval in China for the treatment of chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL) in adult patients who have previously undergone at least one therapy. This milestone was achieved through a thorough evaluation process by China's National Medical Products Administration (NMPA), which relied on the favorable outcomes from two pivotal clinical trials.


One of the critical studies that contributed to this approval was the global Phase III ASCEND trial, which compared Calquence to two other treatment options, idelalisib plus rituximab (IdR) and bendamustine plus rituximab (BR), for patients with relapsed or refractory (R/R) CLL. In this trial, patients treated with Calquence displayed remarkable progress, with 88% being free from disease progression after 12 months, in contrast to the 68% of patients treated with IdR/BR who achieved the same outcome. Encouragingly, longer-term follow-up data revealed that 62% of those treated with Calquence were disease-free and alive at 42 months. In contrast, only 19% of IdR/BR group patients achieved this milestone.


Furthermore, a Phase I/II trial was explicitly conducted for Chinese adults with R/R CLL, shedding light on the medication's efficacy within this population. In this trial, Calquence exhibited an impressive overall response rate (ORR) of 83.3%. The data also showed that at a median follow-up of 20.2 months, the median progression-free survival (PFS) had not been reached, and the 12-month and 18-month PFS rates stood at 90.7% and 78.8%, respectively. Notably, the safety and tolerability profile of Calquence in these trials were consistent with what had been observed in previous clinical trials, confirming its reliability as a treatment option.


It's worth noting that Calquence had already been approved for treating CLL and SLL in the United States and Japan and for CLL in the European Union and other countries, both for treatment-naïve patients and those with R/R disease.


 

Forxiga has secured approval in China for reducing the risk of cardiovascular death, hospitalization, and urgent visits for heart failure in adults with symptomatic chronic heart failure. This milestone establishes Forxiga (dapagliflozin) as the sole heart failure therapy proven to offer a mortality benefit, extending its endorsement to patients regardless of their ejection fraction status. Formerly approved in China solely for heart failure patients with reduced ejection fraction (HFrEF), this authorization now paves the way for Forxiga to curtail the risk of cardiovascular death and hospitalizations in adults grappling with symptomatic chronic heart failure, irrespective of their ejection fraction phenotype.


China's National Medical Products Administration (NMPA) granted this approval, leveraging affirmative outcomes from the DELIVER Phase III trial. Notably, a pre-specified pooled analysis of the DELIVER and DAPA-HF Phase III trials further positioned dapagliflozin as the first medication designed for heart failure to exhibit a mortality benefit spanning the entire ejection fraction spectrum.


Heart failure, a multifaceted syndrome emerging when the heart fails to circulate blood throughout the body efficiently, affects approximately 4.5 million individuals in China. A statistic reveals that half of heart failure patients meet mortality within five years of diagnosis. Those with an ejection fraction above 40% face elevated risks of death and hospitalization, heightened symptom load and physical constraints that severely compromise their quality of life. Moreover, heart failure places substantial pressure on China's healthcare system, driving up costs and resource utilization, with hospitalization constituting the primary contributor to the treatment burden—HF patients spend an average of 30 days hospitalized within a year.


The DELIVER study encompassed an international, randomized, double-blind, parallel-group, placebo-controlled, event-driven Phase III trial. This trial assessed Forxiga's efficacy compared to placebo in treating heart failure patients with a left ventricular ejection fraction (LVEF) exceeding 40%, with or without type 2 diabetes (T2D). DELIVER, involving 6,263 randomized patients, is this patient group's largest clinical trial to date. After a median follow-up of 2.3 years, the results demonstrated Forxiga's effectiveness in meeting its primary endpoint by reducing the cardiovascular (CV) death or worsening heart failure by 18%.


The DAPA-HF trial, titled Dapagliflozin And Prevention of Adverse Outcomes in Heart Failure, encompassed a diverse patient group of 4,744 individuals with HFrEF, with and without T2D. This international, multi-centre, parallel-group, randomized, double-blinded Phase III trial evaluated the effect of Forxiga 10mg, administered once daily in addition to standard care. The primary endpoint was time to the first occurrence of a worsening HF event (hospitalization or an urgent HF visit) or cardiovascular (CV) death. The median follow-up period was 18.2 months. Notable secondary endpoints included the total number of heart failure-related hospitalizations (hHF), CV deaths, and the total symptom score on the Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline to 8 months.


 

Soliris has received approval in China for treating refractory generalized myasthenia gravis in adults. This regulatory milestone marks the third approval for Soliris in China, which the company stated that it is a significant development in expanding access to rare disease medicines.

The approval was based on the complete results of REGAIN trial, which aimed to evaluate the efficacy and safety of Soliris as a treatment option for adults with refractory generalized MG. The study likely involved a randomized, placebo-controlled design, with participants receiving either Soliris or a placebo for a specified duration. The primary endpoint was a change in Myasthenia Gravis Activities of Daily Living Profile total score at week 26. After the open-label extension study, there was an improvement in Myasthenia Gravis Activities of Daily Living Profile total score in rituximab-treated and rituximab naive patients.


In addition to its approval for refractory generalized myasthenia gravis, Soliris has recently become available in China for paroxysmal nocturnal haemoglobinuria (PNH) and atypical haemolytic uraemic syndrome (aHUS).


 

Bayer announced that Kerendia (finerenone) had received an expanded indication in China for the treatment of a broad range of patients with chronic kidney disease (CKD) and type 2 diabetes (T2D). It is now approved for stages 1-4 CKD associated with T2D.


The Chinese National Medical Products Administration (NMPA) granted approval for a label update based on the results of the Phase III FIGARO-DKD cardiovascular outcomes study. This label extension allows Kerendia to be used in the early stages of CKD associated with T2D.


The Phase III FIGARO-DKD study demonstrated the positive impact of Kerendia on cardiovascular outcomes in a diverse population of patients with CKD and T2D. The study included patients with stages 1-4 CKD and provided strong evidence for the effectiveness of Kerendia in reducing the risk of CV events.

The expanded indication for Kerendia in China marks another significant step in addressing the needs of patients with CKD and T2D, providing hope for improved outcomes and better management of the disease.


 

AstraZeneca's drug Calquence has received regulatory approval in China for treating mantle cell lymphoma in adults who have already undergone treatment. The approval marks the first time Calquence has been approved for use in China.

Calquence is an oral medication that inhibits Bruton's tyrosine kinase, an enzyme involved in the development and progression of cancer cells. It can be administered as a monotherapy for mantle cell lymphoma.

The approval was granted by the National Medical Products Administration (NMPA) based on results from two clinical trials demonstrating the drug's efficacy and safety profile. The drug has shown an 82% overall response and a 35% complete response in Chinese patients.

The approval of Calquence in China provides a new alternative for difficult-to-treat cancer. AstraZeneca plans to make the drug available to patients in China as soon as possible.



 

Nubeqa, an oral androgen receptor inhibitor (ARi), received approval from the Chinese National Medical Products Administration (NMPA) for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC). The drug is indicated in combination with docetaxel. This additional indication is based on data from the Phase III ARASENS trial.

Nubeqa was previously approved in China for treating non-metastatic castration-resistant prostate cancer (nmCRPC) in patients at high risk of developing metastatic disease.

The approval was based on the Phase III ARASENS trial. The trial demonstrated that the combination of Nubeqa, androgen deprivation therapy (ADT), and docetaxel reduced the risk of death by 32.5% versus ADT plus docetaxel. The treatment also showed consistent benefits across relevant secondary endpoints; there was no difference in adverse events between the arms.

Bayer and Orion Corporation have jointly developed Nubeqa.


 

GSK has announced that the China's National Medical Products Administration (NMPA) accepted a new drug application (NDA) for Nucala (mepolizumab) to be used as an add-on maintenance treatment for severe eosinophilic asthma (SEA). This marks the first targeted anti-interleukin-5 (IL-5) treatment for adult and adolescent patients with SEA in China if approved.


The NDA is supported by positive data from a Phase III trial among Chinese patients and the global SEA development program that included - DREAM, MENSA, and SIRIUS. The trials have determined the efficacy and safety profile of Nucala for severe eosinophilic asthma patients. The Phase III trial in Chinese patients, which lasted for 52 weeks, evaluated the effect of Nucala as an add-on therapy in patients with SEA. The trial's primary endpoint was to reduce the annual rate of clinically significant exacerbations compared to a placebo. The study found that the efficacy in the Chinese population was consistent with the non-Chinese population with SEA.


Nucala is currently approved in China for treating adults with eosinophilic granulomatosis with polyangiitis (EGPA). In January 2023, it was included in the National Reimbursement Drug List. However, it is not yet approved for treating SEA in China.

 

The National Medical Products Administration approved Enhertu (trastuzumab deruxtecan) for treating adult patients with unresectable or metastatic HER2-positive breast cancer previously treated with one or more anti-HER2-based regimens.

The approval was based on Phase 3 DESTINY-Breast03, progression-free survival was the primary endpoint, and overall survival was the secondary endpoint. The risk of disease progression or death was reduced by 72% versus trastuzumab emtansine. The median progression-free survival was not met in the Enhertu arm versus 6.8 months in patients on trastuzumab emtansine.


The complete response was 16.1%, and a partial response was observed in 63.6%. Only 8.7% and 25.5% of patients who were on trastuzumab emtansine achieved complete response and partial responses.


Enhertu was an antibody-drug conjugate (ADC) developed by AstraZeneca and Daiichi Sankyo. In 2022, China's NMPA granted Breakthrough Therapy Designation and Priority Review.

 

​Tislelizumab is approved for advanced gastric or gastroesophageal junction adenocarcinoma with high PD-L1 expression in combination with chemotherapy. Chinas's National Medical Products Administration (NMPA) approved it with fluoropyrimidine and platinum chemotherapy.



The approval was based on Phase 3, a placebo-controlled RATIONALE 305 trial evaluating tislelizumab in combination with chemotherapy. The trial included 997 participants worldwide, with overall survival being the primary endpoint. Progression-free survival was the secondary endpoint. Tislelizumab plus chemotherapy significantly improved overall survival, 17.2 months versus 12.6 months in patients on placebo.


Tislelizumab is yet to receive approval in the US and Europe; it is currently under review for advanced or metastatic esophageal squamous cell carcinoma.


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