More than 10 months after its submission, Tian Tan Biologics (SH600161, stock price 17.61 yuan, market capitalization 34.822 billion yuan) withdrew its application for listing of a hemophilia drug that cost 266 million yuan to develop.

On the evening of November 19th, this leading domestic blood product company released a statement, stating that its subordinate enterprise, Chengdu Rongsheng Pharmaceutical Co., Ltd. (hereinafter referred to as Chengdu Rongsheng), withdrew the drug registration application for "Recombinant Human Coagulation Factor VIIa for Injection". The reason was that according to the review opinions of the CDE (National Medical Products Administration Drug Evaluation Center), supplementary information was required. It became the first domestically produced recombinant human coagulation factor VIIa biological product to be approved for market launch in China. However, from the indication perspective, Anqixin's application scope is much smaller than Nuoqi.

The products under Tian Tan Biotechnology are more similar to Nokir. On December 31 last year, the company released the summary report of the Phase III clinical trial of the injectable recombinant human coagulation factor VIIa. Its indication is for the treatment of bleeding in adult and adolescent patients (aged 12 and above) in 5 specified situations, as well as for the prevention and treatment of bleeding during surgical operations or invasive procedures.

However, in the latest announcement, the indication column did not categorize the patient groups by age, which is basically the same as that of the imported original drug.

On November 20th, the reporter called the public contact number of the secretary office of Tian Tan Biotech. The person on the other end provided a phone number for internal media communication. The reporter then called this number several times, but as of the time of publication, no one answered.
The issue of "completeness" needs to be addressed.
It is known that An Qi Xin from Zhengda Tianqing participated in this year's national medical insurance negotiation. The specific results will be released in early December.
According to the relevant materials, Chagang Tianqing stated that this drug has achieved local production, breaking the import dependence and resolving the shortage of imported rFⅦa supply. Specifically, the team from the Chinese Academy of Medical Sciences' Hematology Hospital surveyed 38 hemophilia treatment centers in 22 cities across the country. Only 28 centers (73.7%) could purchase the coagulation factor VIIa drug; 7 of these centers were located in economically underdeveloped areas, and only 2 of them could obtain the coagulation factor VIIa drug.
On November 20th, Wang Lixin, director of the Tianjin Youai Rare Disease Care Service Center, told the “Daily Economic News” that Anqixin, as the “first domestically produced” related drug, deserves recognition for filling a gap in the market. however, as a recombinant human coagulation factor VIIa biological product, the drug’s indications do not include patients with congenital coagulation factor VII deficiency, indirectly indicating that the company’s clinical trial participants were limited in scope.
Public data also show that An Qi Xin's approval was based on a national multi-center phase III clinical trial. This study included 60 patients with hemophilia who were resistant to inhibitors, and it evaluated a total of 551 bleeding incidents.
“In fact, the factor VIIa drug is primarily used to treat patients with congenital factor VII deficiency, and only secondarily for those with hemophilia accompanied by inhibitors. However, the number of patients in the latter group is greater than that in the former.” Wang Xinli said.
Moreover, An Qixin has not addressed the medication issue for children under the age of 12 with hemophilia. Currently, these patients have only one option, namely Norix. It is worth noting that childhood is a crucial period for hemophilia treatment. Data shows that due to insufficient standardized preventive treatment, about 50% of hemophilia patients under the age of 14 in China have disabilities.
Over 90% of the market is occupied by foreign investors.
An article from the People's Daily's client app shows that each year, over 200,000 new patients with rare diseases are added to our country's population. Approximately 70% of these cases occur in childhood. The country has made many investments and supports in the past, but relevant drugs are still in short supply. During this year's National Two Sessions, Li Qiu, a professor at the Children's Hospital of Chongqing Medical University and a National People's Congress representative, pointed out that there are very few manufacturers of drugs for rare diseases in children, and only about 10 well-known specialized children's pharmaceutical companies exist. Moreover, over 90% of the market share is held by a few foreign enterprises.
Securing these markets is the responsibility of domestic pharmaceutical companies. What is encouraging is that positive changes are taking place. Data shows that in the first half of 2025 alone, 21 rare disease drugs have been approved in China, covering multiple areas with long-term drug shortages and high risks among special populations.
Among them, some drugs have achieved the coverage of multiple indications, eliminating the barriers in medication use between adults and children. This progress stems from the "Starlight Project for Children's Drug Research" and the "Green Channel for Rare Disease Approval" launched at the national level in recent years. These initiatives provide institutional support and significantly simplify the operational procedures.
How significant are the changes that domestic pharmaceutical companies' efforts to develop rare disease drugs have brought to the existing market? Wang Lixin has a deep understanding of this. He told the "Everyday Economic News" reporter, "Recombinant Human Coagulation Factor VIa for Injection" is a relatively "less popular" drug in terms of research and development. But since domestic pharmaceutical companies began to focus on research and development, Nuoqi has started to continuously reduce its prices. Currently, its unit price has dropped from over 7,000 yuan to 4,100 yuan, significantly improving the accessibility of the drug.
Moreover, in recent years, foreign enterprises have launched patient assistance programs for this medicine. The latest assistance policy sets the upper limit of the drug price at 20%. If the patient's out-of-pocket expenses exceed this amount after the medical insurance reimbursement, 20% of the drug price will be subsidized; if it does not exceed this amount, the patient can use the medicine at "zero out-of-pocket cost". Even if no domestic drugs have been launched yet, when foreign companies see that domestic enterprises have been intensively investing, they will also adjust their pricing strategies in advance. According to Wang Lixin's perception, in the field of rare disease children's medication, domestic pharmaceutical companies are accelerating their pace. Although it will take a process to catch up with the original research and development companies, they are already actively conducting research, which is a good start.
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