Rongchang Bio-Tetaxip and Videcituzumab entered the National Medical Insurance Catalogue.

Beijing, December 6 (Xinhua) The biggest highlight of this year’s medical insurance negotiations is the suspense brought by the participation of more than 20 domestic innovative drugs in the negotiations.

On December 3, the new medical insurance catalogue of the National Medical Insurance Bureau was officially released. Rongchang Bio, which promoted two "world-class domestic innovative drugs" independently developed at one time to the medical insurance catalogue, immediately became the focus.

Taita Xipu (trade name: Taiai? ), vidiximab (trade name: Aidixi? ) was conditionally approved for listing by National Medical Products Administration (NMPA) in March and June, 2021 respectively. The former is the world’s first "dual-target" biological new drug for the treatment of systemic lupus erythematosus, and the latter is the first original antibody-coupled (ADC) drug in China. It is these two innovative drugs that have been approved to enter the medical insurance catalogue this time.

In less than half a year, two world-class original new drugs have been approved for listing; Just a few months later, two new drugs entered the medical insurance catalogue at the same time. Rongchang Bio’s innovation ability, product quality and commercialization speed are once again presented.

China’s self-developed world-class new drug "quickly" reduced the price into medical insurance

Why do innovative drugs get attention when they enter the medical insurance catalogue? Because this means the opening of a new life channel for patients with corresponding indications. Pay a lower fee, use the world’s leading new drugs and good drugs, and stay away from "poor diseases".

In fact, according to preliminary estimates, the adjustment of the national medical insurance drug list in the past three years, compared with the pre-negotiation market price, has reduced the burden on patients by nearly 170 billion yuan and benefited 100 million patients through negotiation price reduction and medical insurance reimbursement.

"The two pioneering new drugs, Taitacip and Vidicotuzumab, are quickly reduced in price into medical insurance, which can improve the accessibility of these two world-class biological new drugs in the country, help China’s over one million patients with systemic lupus erythematosus and the vast number of patients with gastric cancer to get effective treatment, reduce the economic burden of patients and their families, and better play the social benefits of drugs." Dr. Fang Jianmin, CEO and chief scientific officer of Rongchang Bio, said.

Systemic lupus erythematosus patients and other first domestic innovative drugs.

Systemic Lupus Erythematosus (SLE) is a lifelong systemic immune disease, which can cause damage to kidneys, cardiovascular system, lungs, digestive system, blood system, blood vessels, eyes and other organs and tissues, and significantly increase the risk of death of patients. Its harm makes people talk about it. According to "Guidelines for Diagnosis and Treatment of Systemic Lupus Erythematosus in China in 2020", there are more than 1 million patients with systemic lupus erythematosus in Chinese mainland, and the prevalence rate is the second highest in the world.

However, for a long time, a large group of patients have been faced with the dilemma of drug use-traditional glucocorticoids, immunosuppressants, etc. are often accompanied by great toxic and side effects, which are unbearable for patients. At the same time, it is difficult to "breed" new therapeutic drugs. In the past 60 years, the US Food and Drug Administration (FDA) only approved a drug for the treatment of systemic lupus erythematosus in 2011 (Berizumab developed by GlaxoSmithKline).

Rongchang Bio was included in the national medical insurance drug list this time, which is tetasip for injection (specification: 80mg/ piece). It is the first innovative drug approved in the treatment of systemic lupus erythematosus in China, and it is also the first-in-class biological drug in the world.

Different from the single-target design of listed drugs, the "double-target" design of Tatasip can inhibit BLyS and APRIL, two key factors that make B lymphocytes differentiate and mature at the same time, which can reduce the immune response of the body more effectively and play a "two-pronged" effect on treatment. The key clinical data showed that the systemic lupus erythematosus response index (SRI) in the high-dose group was significantly higher than that in the placebo control group (79.2% vs 32.0%) after 48 weeks of treatment, and the improvement of SRI was significantly better than that of the new biological drugs currently on the market. At the same time, the macromolecular drug Tetasip can be metabolized directly through cells, instead of liver and kidney metabolism, which can significantly reduce the side effects of traditional drugs and has higher safety. In a word, as a new drug with new target, new structure and new mechanism, Tetasip brings infinite new hope to the global SLE medical field.

(Photo courtesy of the enterprise, issued by Yangguang. com)

Professor Zhang Fengchun, the head of clinical trial of Taitacip and the chief physician of Peking Union Medical College Hospital, said: "Compared with the existing treatment methods, the main therapeutic indexes of Taitacip have been greatly improved, which is a major breakthrough in the treatment of systemic lupus erythematosus, marking that China has taken the lead in the field of research and development of new drugs for the treatment of systemic lupus erythematosus. The inclusion of this drug in the national medical insurance drug list will further improve the accessibility of drugs, greatly reduce the medical burden of patients with systemic lupus erythematosus, and bring them higher quality survival benefits. "

Tetasip’s innovation has been recognized internationally, and its invention patents have been authorized by China, the United States, Europe and other countries and regions. Besides the indications of systemic lupus erythematosus, domestic and international clinical trials of Tatasip for neuromyelitis optica spectrum diseases, rheumatoid arthritis, IgA nephropathy, Sjogren’s syndrome, multiple sclerosis and myasthenia gravis are being conducted in an orderly manner.

To fill the blank of back-line therapy for gastric cancer patients with HER2 overexpression in China.

Another new drug of Rongchang Bio, which is included in the medical insurance catalogue, is vidiximab for injection (specification: 60mg/ piece), which is approved for patients with locally advanced or metastatic gastric cancer (including adenocarcinoma of gastroesophageal junction) who have received at least two systemic chemotherapy (HER2 immunohistochemical results are 2+ or 3+).

In China, gastric cancer is the second largest cancer species after lung cancer, with an annual incidence of 400,000, ranking first in the world. The morbidity and mortality are both high. 80% of patients with gastric cancer in China were in advanced stage when they were diagnosed. For most patients with advanced gastric cancer, chemotherapy is still the first choice for first-line treatment in the past few decades. However, the therapeutic effect of chemotherapy is limited, and the side effects are great, and the precise drugs for patients with gastric cancer who overexpress HER2 are even blank.

According to the latest data, the objective remission rate (ORR), disease control rate (DCR), median progression-free survival (PFS) and median overall survival (OS) of patients with HER2 overexpression gastric cancer treated with vidicon were 24.8%, 42.4%, 4.1 months and 7.9 months, respectively, which showed higher efficacy and better safety.
Therefore, China’s first original antibody-coupled (ADC) drug, vidiximab, developed by Rongchang Bio, went on the market, which filled the blank of back-line treatment for patients with gastric cancer whose HER2 was overexpressed in China.

As an ADC drug, vidiximab has the characteristics of antibody targeting and small molecule drug killing, and can accurately identify and kill tumor cells by targeting HER2 protein on the tumor surface. It has achieved world-leading clinical data in clinical trials for treating gastric cancer, urothelial cancer, breast cancer and other tumors.

Professor Shen Lin, vice president of Peking University Cancer Hospital, director of the Department of Gastroenterology and Oncology, and deputy director of Beijing Institute of Cancer Prevention and Treatment, said: "When vidiximab is featured by a wider range of treatment beneficiaries, a more balanced curative effect, safe benefits and a more economical and convenient detection process, and it has made revolutionary progress in the history of anti-HER2 treatment for gastric cancer, it is also inevitable that it will be highly recognized by National Medical Products Administration and the National Medical Insurance Bureau."

At the press conference on the adjustment of the national medical insurance drug list in 2021, Professor Shi Yuankai of the Cancer Hospital of China Academy of Medical Sciences mentioned that vidiximab is the first original antibody-coupled drug in China, and it has achieved good results in tumors such as gastric cancer and breast cancer. It is effective not only for patients with overexpression of human epidermal growth factor receptor -2(HER-2), but also for patients with low expression of HER-2. This time, the price of vidiximab was successfully reduced and entered the medical insurance, which benefited more cancer patients and filled the gap in the guarantee. While improving the drug guarantee for gastric cancer to the international mainstream drug use level, the burden on patients was greatly reduced.

Like Tatasip in the treatment of systemic lupus erythematosus, Videcituzumab is highly recognized internationally: this new drug is the first ADC drug in China that has been recognized as a breakthrough therapy by both FDA of the United States and NMPA of China. In August, 2021, Seattle Gene, an internationally renowned biopharmaceutical company, obtained the global (except Asia-Pacific) exclusive license agreement for vidicon with a down payment of up to US$ 2.6 billion and milestone payment, and a gradient sales commission of more than 15%. The transaction volume set a new record for overseas authorization of a single product of China pharmaceutical companies.

Innovative drugs are included in medical insurance, and the volume will obviously drive more innovations.

The medical reform in China continues to deepen, and the time for innovative drugs to be included in medical insurance has been greatly shortened.

The Blue Book on the Progress and Effectiveness of Medical Insurance Drug Management Reform shows that among the 34 innovative drugs listed from 2016 to 2020, 26 drugs have been included in the medical insurance catalogue, accounting for 76.5%. At the same time, in 2017, the time required for new drugs from listing to inclusion in medical insurance will be shortened to 1-8 years in 2019 and further reduced to 0.5-5 years in 2020.

The speed at which Rongchang Bio’s two innovative drugs entered the medical insurance is also a proper "top student". The characteristics of the two innovative drugs, such as "initiative", remarkable clinical effect, better safety and huge patient group, all escort their rapid inclusion in the medical insurance catalogue.

As for the new drugs with good curative effect, strong innovation and large clinical demand, it can quickly expand the sales channels and greatly increase the sales and market share of new drugs in a short time.

For example, according to the Blue Book on the Progress and Effectiveness of Medical Insurance Drug Management Reform, the dosage and amount of 17 kinds of anticancer drugs successfully negotiated in 2018 increased by 25.8 times and 8.8 times in the first quarter of 2021 compared with the first quarter before the negotiation (the third quarter of 2018); In the first quarter of 2021, compared with the first quarter before the negotiation (the fourth quarter of 2019), the amount of drugs successfully negotiated in 2019 increased by 10.4 times and the amount increased by 2.7 times.

Rongchang Bio-Tatasip and Vidicotuzumab are aimed at "a wide range of clinical unmet needs". With the opportunity of entering the medical insurance drug list, these two heavy new drugs may achieve rapid volume increase and gain more market share and economic benefits. And these will eventually lead to more innovations.

With the continuous introduction of policies to encourage innovation, such as accelerating the review of new drugs and normalizing medical insurance negotiations, enterprises that focus on early accumulation, do not blindly follow the trend of project establishment, and closely focus on how to solve the actual clinical needs are bound to stand out.

Rongchang biology is one of them.

Rongchang Bio, founded in 2008, has been focusing on the discovery, development and commercialization of antibody drugs such as antibody drug conjugate (ADC), antibody fusion protein, monoclonal antibody and bispecific antibody. At present, Rongchang Bio has developed more than 20 candidate biopharmaceutical products, and more than 20 indications of 7 products are undergoing clinical trials or have entered the commercialization stage.

In the best era of the development of innovative pharmaceutical companies, inclusion in the medical insurance catalogue has just begun for Rongchang creatures with outstanding research and development capabilities and rich reserves.