New Consideration On Commercialization Of Innovative Drug Companies On The New Payment Platform Of Ovarian Cancer New Drug Launch

Following the approval of listing in Hongkong and Macao, in January 13, 2020, ZEJULA, the first drug ovarian cancer drug, was released on the mainland in January 13, 2020.

In September 2016, Mr. Ding bought the exclusive R & D and sale rights of Nila Pali in the Chinese market from Tesaro, a cancer research and development bio pharmaceutical company. In March 2017, ZEJULA was approved in the United States and approved in Europe in November of the same year. It is the world's first PARP inhibitor approved for all platinum sensitive recurrent ovarian cancer patients, regardless of whether BRCA is mutated.

In December 2019, the China National Drug Administration approved Nila Paley as a new drug application for maintenance treatment of adult patients with recurrent or epithelial ovarian cancer, complete or partial remission of platinum chemotherapy.

Nila Pali is the second listed PARP inhibitor in China, which has been approved for the first time in China in August 2018 for maintenance therapy in patients with platinum sensitive recurrent ovarian cancer.

Over the past year, a number of local innovative pharmaceutical companies in the first echelon of innovative drugs have completed a breakthrough in zero. From the US shares of the second Ding, the baiji Shenzhou to the listed XinDa bio, Jun Shi biology, Song Li and so on, all products have been approved to go public, and have opened more commercial operations.

These innovative drugs often match the strong multinational companies with strong body size. The background of commercial team members is also closely related to large pharmaceutical companies. In the environment where multinational companies are spending great efforts to participate in national health insurance negotiations, these innovative pharmaceutical enterprises are facing more challenges and more space on the commercial competition track.

Hot "small molecule"

In recent years, PARP inhibitors are a new kind of anti-cancer small molecule drugs, which are different from those in recent years. PARP is a DNA repair protein in cells, which mainly repairs single strand damage of DNA. PARP inhibitors can enhance the efficacy of radiotherapy and alkylating agents and platinum drugs chemotherapy by inhibiting DNA damage and repairing tumor cells and promoting apoptosis of tumor cells.

At present, the world has approved 4 PARP inhibitors listed, namely AstraZeneca's Ola Pali, Clovis's Lu Kapali, Tesaro's IRA Paley and Pfizer's razolazol Paley. Indications and follow-up research are focused on the BRCA mutation of ovarian cancer, breast cancer and prostate cancer. Due to BRCA mutation, BRCA protein is inactivated, and DNA damage repair in tumor cells depends mainly on PARP.

Compared with women with the highest incidence of breast cancer, ovarian cancer is known as the leading cause of death in gynecologic malignancies. The number of new ovarian cancer cases is nearly 300 thousand every year, and the number of deaths is over 150 thousand. According to data from the National Cancer Center, 52 thousand new cases of ovarian cancer occurred in China in 2015, with 23 thousand deaths. Ovarian cancer is the most dangerous cancer in gynecologic malignancies. The lowest 5 year survival rate is 39%, and 70% patients will relapse within 3 years. Over the past thirty years, ovarian cancer has been treated mainly by surgery and chemotherapy. In addition to traditional treatment regimens, maintenance therapy is an important means to control disease progression in advanced ovarian cancer treatment.

Most ovarian cancer patients were diagnosed late. Surgery and chemotherapy are common treatments for ovarian cancer. Initial patients usually receive clinical remission. However, ovarian cancer has a recurrence rate of up to 85%, which leads to limited therapeutic options for recurrent platinum sensitive ovarian cancer patients.

The listing of PARP inhibitors provides a new option for these patients. Li Li, a Cancer Hospital Affiliated to Guangxi Medical University, said, "the approval of Nila Pali in mainland China is based on the results of the NOVA study of its international phase three clinical trial."

In recent years, China has introduced a series of policies to encourage R & D and innovation in the field of medicine, and promote the transformation of the pharmaceutical industry from imitation to innovation and from home to the whole world. With the continuous accession of pharmaceutical chain, business insurance and other industrial chain partners, the comprehensive empowerment of top innovative pharmaceutical companies from upstream research to downstream commercial operation is expected to further accelerate.

According to the data from Ding Ding, based on IQVIA data, Le is now the PARP inhibitor with the highest market share in Hongkong, and its market share reached 77% in the third quarter of 2019.

New mode of commercialization

Domestic innovative pharmaceutical companies are catching up with foreign investors in the field of PD-1, and other fields are not easy. The ability of commercial insurance access has gradually become a factor that the domestic innovative pharmaceutical enterprises consider more heavily.

In August 2018, Nila Pali's "rival" Ola Pali was approved to be listed in China for the maintenance treatment of platinum sensitive recurrent ovarian cancer patients. In November 2019, Ola Pali entered the medical insurance catalogue in the form of negotiation. The patients with platinum sensitive recurrent epithelial ovarian cancer, oviductal carcinoma or primary peritoneal cancer were effective from January 1, 2020 to December 31, 2021. In December 5, 2019, AstraZeneca and Mercedes jointly announced that Ola Pali was approved for first-line maintenance therapy in patients with advanced BRCA ovarian cancer.

At the same time, Paley's public welfare fund launched the corresponding patient assistance project. The company launched a comprehensive care platform for ovarian cancer patients, and then Ding said, "through a series of public welfare and financial services programs to build an innovative payment ecosystem, from patients and healthy people to enhance the ability to pay for innovative drugs in two dimensions, to form a sustainable multi-party payment mechanism, and to create a new normal business mode of innovative drugs listed on the market". ","

According to the introduction, the project will include three parts: early enjoyment plan for patients, financial phasing plan and health insurance for healthy people. The early enjoyment plan and the financial phasing plan are designed to reduce the disposable payment threshold of patients through financial means. The care platform extends to the healthy population outside the patients. Combined with a number of Business insurance company, it will synchronize the listing of dozens of health insurance reimbursement drugs list, including the "medicine God insurance" and so on. The people who purchase these health risks will be reimbursed by Nila Pali if they are suffering from ovarian cancer in the future.

As for the pressure to choose more access insurance providers from competitors, Liang Yi, chief business officer of Ding medicine and greater China president, said in an interview with the twenty-first Century economic report, "promoting commercial insurance is definitely not just for commercial competition, but indeed to change the current ability to pay. Whether competition is okay or not, but new products first enter the commercial insurance directory before entering health insurance. I think this will become a new normal for China's future cancer products listing. More than a decade ago, the listing was entirely product oriented, but now all pharmaceutical companies' slogans are patient centered, designed for patient services.

From the commercial insurance side, the domestic compensation experience is still not good. According to the data shown by general manager and COO Xie Bangjie, the commercial health insurance premiums in 2018 were about 550 billion, and the reparations were 170 billion, accounting for only 120 billion of the government's business, accounting for only 7% of the patients' own expenses.

One of the partners, CEO Zhang Xiaodong of Shanghai magnesium Health Technology Co., Ltd., told the twenty-first Century economic report that the insurance industry is also undergoing tremendous changes in the pharmaceutical industry. "Last year, after the cooperation with Microsoft, the Banking Regulatory Commission issued two new regulations in the past two months. The first is to revise the new" health insurance management measures ", which explicitly encourages the insurance companies to develop medical insurance products, and guarantee the application expenses of new drugs, new medical devices and new diagnosis and treatment methods in medical services. It has never been imagined that a health risk should be explicitly incorporated into innovative Chinese medicines, medical devices and innovative therapies into China's commercial health insurance. Second, the latest part of the group insurance is further strictly regulated. But there is still a huge gap between pharmaceutical companies and insurance companies. We hope to bridge the middle. Now, a number of insurance companies slowly turn medicines into health insurance standards. Commercial insurance may promote the commercialization of many innovative pharmaceutical companies in China in the future, because medical insurance is unlikely to be all inclusive, and there is tremendous pressure at the expense of itself, who can make good use of the means of commercial insurance to bring opportunities in competition or in the process of serving the common people.