I went through the EddingPharm IPO document. There are 146 references to Vascepa. There are 0 references to mineral oil. A few notes from the document: Vascepa has no competitors in China for the FDA-approved indication of reducing CV events. Vascepa is expect to compete with other TG-lowering drugs, primarily including extended-release niacin and fibrates, for the treatment of severe HTG in China
Vascepa became the first CVD drug to obtain approval in the Hainan Boao Pilot Zone, which enables domestic PRC patients to benefit from globally innovative drugs that are not yet approved in China and enables us to collect real-world evidence to support NMPA registration
Vascepa has no approved competitors in China for its FDA-approved indication for CRR. As of the Latest Practicable Date, only one competing generic was marketed in China with only one approved indication, TG reduction in severe HTG (500 mg/dL) adult patients. This competing generic has not been approved for persistent CRR, the FDA-approved indication of Vascepa with a larger potential market. Based on the results of the REDUCE-IT trial, Vascepa is the first product that demonstrated a statistically significant reduction in CV risk beyond cholesterol-lowering therapy in high risk patients approved for treatment in the U.S. and has the potential to be the first of such product in China once approved, according to the Frost & Sullivan Report.
As of the Latest Practicable Date, Vascepa had already been recommended by seven clinical guidelines in China, including the 2023 China Guidelines for the Management of Blood Lipids. We will also seek to utilize innovative channels, including e-commerce and internet hospitals, for launch preparation. We plan to launch targeted recruitment of sales in core cities, onboard both medical and marketing teams for Vascepa and expand the product coverage to target hospitals. We will seek to rapidly secure NRDL listing and establish partnerships with private insurance providers. We plan to conduct Health Economics and Outcomes Research (HEOR) and Real-world Evidence (RWE) studies for Vascepa
In addition, we are required to make a milestone payment of US$5.0 million (equivalent to RMB35.8 million) as Vascepa has received NDA approval from the NMPA, and we may be required to pay further milestone payments to Amarin of up to an aggregate of US$148.0 million (equivalent to RMB1,059.2 million) if certain development and sales milestones are achieved. In addition, we will pay Amarin royalties at tiered double-digit percentage rates in the range of low- to mid-teens on the net sales of Vascepa, until the later of (i) the date on which Vascepa is no longer covered by a valid claim of a relevant patent, or (ii) the twelfth anniversary of the first commercial sale of Vascepa in China. Our agreement with Amarin will remain in effect until the expiration of the royalty term and may be terminated early by either party for the other party’s uncured material breach or as a result of bankruptcy. In addition, with a notice period, we can terminate the agreement immediately following the third anniversary of the first commercial sale of Vascepa in China
In December 2020, we entered into an exclusive distribution agreement with a distributor for pilot sales of Vascepa in Hainan Boao Pilot Zone according to the PRC laws and regulations in response to urgent clinical needs for imported drugs, and generated gross revenue of RMB8.5 million and RMB16.6 million for the years ended December 31, 2021 and 2022, respectively.
Our selling and distribution expenses increased by 5.8% from RMB539.8 million for the year ended December 31, 2021 to RMB571.3 million for the year ended December 31, 2022, primarily due to a RMB64.4 million increase in staff costs as we recruited more senior-level personnel in anticipation of the commercialization of Vascepa and other core pipeline products in the near future, and we recorded more performance-related bonuses to our sales personnel in line with the increase in sales volume,
. It is also unlikely that the invalidation of these U.S. patent claims will have a direct impact on the validity of Chinese patents or patent applications in relation to Vascepa, because the Chinese patents or patent applications in relation to Vascepa are directed to inventions different from those that were declared invalid in the U.S. patents
