In recent years, with the normalization of collection and national policies to support the development of pharmaceutical innovation, innovation has become the main theme of the development of pharmaceutical companies. At present, domestic pharmaceutical companies are accelerating innovation and transformation to create new quality productivity. According to the incomplete statistics announced by the State Drug Administration and various enterprises, more than ten domestic Class 1 new drugs are expected to be approved for listing in 2024, and a large number of new drugs are included in the priority review list, which is expected to further meet the unmet treatment needs of domestic patients.

For example, in the field of rare diseases, the State Drug Administration has included a number of new drugs for rare diseases in the priority review list since the second half of 2023, and they are expected to be approved for listing within the year.

The oral suspension of Sperogenix Therapeutics’ vamorolone has been included for priority review for Duchenne muscular dystrophy (DMD) on 18 February 2024. DMD is a fatal rare X-linked degenerative neuromuscular disease with a life expectancy typically of no more than 40 years. Vamorolone does not cause local tissue expansion and corticosteroid-associated toxicity in local tissues, which is expected to lead to a safer treatment option for children and adolescents with DMD. The product has previously been approved for the treatment of DMD in the United States and European Union.

Huadong Medicine's injectable linaccept for recurrent pericarditis (RP) in adults and adolescents aged 12 years and above (provisional) has been included in the priority review and publication on December 19, 2023, and recurrent pericarditis (RP) has been included in the Second Batch of Rare Diseases List in China. RP is an inflammatory disease that affects tissues around the heart, and patients experience repeated episodes of chest pain with life-threatening complications that severely limit physical activity and daily life. Linaccept for injection is a recombinant dimeric fusion protein that blocks interleukin-1α (IL-1α) and IL-1β signaling that is administered subcutaneously weekly. This product has previously been approved by the FDA for the treatment of RP.

A novel oral cortisol synthesis inhibitor from Recordati Pharmaceutical, ‘oxidoostat phosphate film-coated tablets,’ has been included in the priority review list on October 16, 2023, for the treatment of endogenous Cushing's syndrome (also known as endogenous hypercortisolism) in adults. Cushing's syndrome is a group of syndromes caused by excessive cortisol secretion in the adrenal cortex for a long time due to a variety of causes. It is more common in adults aged 40 to 45 years, and females are more than males. Oxidoprost phosphate film coated tablets can control or normalize cortisol levels in adult patients by blocking the synthesis of adrenal cortisol and inhibiting the excessive production of cortisol. The product has been approved for the treatment of adult Cushing's disease in the European Union, the United States and other places.

Another example is in the field of hepatitis C treatment. As early as 2020, yimitasvir phosphate capsule of HEC Pharmaceutical has been approved for marketing, becoming a domestic self-developed oral small molecule new anti-hepatitis C drug, and has entered the national medical insurance directory in 2022. HEC Pharmaceutical expects its combination therapy of antasvir phosphate capsules and inqiangbuvir tablets to be approved for marketing in 2024, which is expected to reduce the treatment costs of patients who rely on imported products for the pan-genotypic chronic hepatitis C population.

In addition, in the traditional Chinese medicine industry, as the CDE accelerates the approval rate of innovative traditional Chinese medicine drugs. According to data statistics, only 1-3 new traditional Chinese medicine drugs were approved each year from 2017 to 2020, the number of new traditional Chinese medicine drugs approved reached 12 in 2021, and 7 new traditional Chinese medicine drugs were approved in 2022 and 2023. In addition, there are 24 applications for the listing of new traditional Chinese medicine drugs in 2023, and the industry is expected to have centralized cash in 2024, and relevant enterprises will enter the harvest period.