A new map of drug research and development of Chinese pharmaceutical companies ADC.
ADC drugs are innovative drugs composed of antibodies, toxins and connectors, the antibody part of the ADC drug realizes the precise targeting of the tumor, and the cytotoxic part further strengthens the killing ability of the tumor, integrating the lethality of the chemotherapy drug and the specificity of precision therapy, and combining the characteristics of small molecule drugs and antibody drugs, known as "biological missiles".
However, due to the immaturity of early technology, Mylotarg, the first ADC drug on the market in 2010, was withdrawn from the market due to fatal liver injury.
Image source: Ping An Securities
With the rise of the third generation of technology, ADC drug research and development has once again become the focus of the global pharmaceutical company layout. Third-generation ADC drugs Porvy, Enhertu and Padcev all achieved rapid post-market sales, achieving revenues of $169 million, $391 million and $222 million in 2020, respectively, while sales of the second-generation ADC drugs Advanced and Kadcyla showed a slowing trend, but remained strong, achieving revenue of $659 million and $428 million in 2020, respectively.
The better prospects of ADC drugs in the market have also attracted global pharmaceutical companies to compete for layout, and China, as a rising star in global drug research and development, is in what position in the ADC track?
At present, there are a total of 400 announced ADC candidates in the world, and there are 144 ADC candidates in china, accounting for 36%, ranking second in the world.
Image source: Southwest Securities
As an important force in global ADC drug research and development, China has 65 ADC drug candidates focused on popular targets, mainly HER2, EGFR, CLDN18.2 and TROP2.
HER2 target is china's ADC drug research and development of the most concentrated target, but also the fastest progress, has been approved for the market of products, is independently developed by Rongchang Biovitas, vidycetizumab once listed, it was put on a dazzling halo, it is the first domestic ADC drug, breaking the ADC drug field no original domestic new drug situation, filling the global HER2 expression of gastric cancer patients after the gap of the front line treatment.
Vidicetizumab has just been approved for listing, it was included in the 2021 edition of the national medical insurance directory, and in the 2 months after listing, it was favored by the internationally renowned pharmaceutical company Seagen, and reached a global exclusive licensing agreement with Rongchang Biologics, with a total transaction amount of up to 2.6 billion US dollars, including a down payment of 200 million US dollars and a milestone payment of up to 2.4 billion US dollars, which refreshed the historical record of the single variety license out transaction of Chinese pharmaceutical companies at that time.
Source: Southwest Securities
According to the classification of therapeutic areas, China's research ADC drugs are mainly distributed in the field of tumors, rare diseases and blood, of which the tumor field is the most, accounting for 66%, and the breakthrough point for domestic ADC drugs to be approved for listing is the tumor field, and the first and only domestic ADC drugs approved for marketing in China are Rongchang Biological's vidicetitizumab, which is used to treat patients with LOCALly advanced or metastatic gastric cancer (including gastroesophageal junction adenocarcinoma) who have received at least 2 kinds of systematic chemotherapy.
According to incomplete statistics, the domestic pharmaceutical companies independently or involved in the research and development of ADC drugs in the phase II clinical trials above a total of 14 models, indications are tumor cancer, the value of concern is that Genting Shinyao gosavuzumab in 2021 has been the China Food and Drug Administration, Taiwan Food and Drug Administration, South Korea's Ministry of Food and Drug Safety (MFDS) to accept the marketing authorization application, another ADC drug loncastuximab tesirine is also approved by the US FDA in April 2021. With the continuous acceleration of the drug research and development process of Chinese pharmaceutical companies ADC, In the future, China's strength in the field of anti-tumor cancer diseases will be greatly improved.
The number of ADC drugs in the research of domestic pharmaceutical companies is more than 3, namely Hengrui Pharmaceutical, Mei Yake, Rongchang Biological, Duoxi Biological, Kelun Botai and Shanghai Pharmaceutical, which is the backbone of China's ADC drug research and development, of which Hengrui Pharmaceutical ranks first with ADC drug research and development products, and Rongchang Biologics has become the "trump card" in the field of ADC drugs with ADC drugs being the first to be approved for listing.
Source: Publicly available information
Hengrui Pharmaceutical was founded in 1970, belongs to the old pharmaceutical companies, as a generic drug to sit on the throne of "pharmaceutical brother", Hengrui Pharmaceutical has been actively innovating and transforming to cope with the fierce competition pattern in the future pharmaceutical industry, and ADC drugs are an important layout area for Hengrui Pharmaceutical to carry out innovation and transformation.
To this end, Hengrui Pharmaceutical has established a new ADC technology platform, with as many as 7 clinical drugs under research. Among them, the fastest progress is SHR-A1811, and clinical trials for the treatment of advanced non-small cell lung cancer have progressed to Phase II. In addition, SHR-A1811 is also the product with the most clinical indications, and the other clinical indications are advanced gastric cancer, gastroesophageal junction adenocarcinoma, colorectal cancer and solid tumor.
With the continuous efforts of Hengrui Pharmaceutical in the field of ADC drugs, Hengrui Pharmaceutical may become the "master of the family" in the field of ADC drugs in China, and then show the style of "pharmaceutical brother".
Founded in 2008, Rongchang Biologics has been concentrating on the layout of ADC drugs as early as ten years ago, and has built an ADC platform covering the whole process from drug discovery, process development to production, and is one of the few pharmaceutical companies in China that has an integrated technology platform for ADC.
Videcetizumab, the first domestically approved ADC drug, has refreshed the historical record of the single variety license out of Chinese pharmaceutical companies with a transaction volume of US$2.6 billion, making Rongchang Bio a hit in the domestic and even global ADC drug field.
It is worth noting that just a few days ago, vidicetitomab was approved by the Chinese Food and Drug Administration for the treatment of patients with locally advanced or metastatic urothelial carcinoma who had previously received platinum-containing chemotherapy and HER2 overexpression, that is, immunohistochemistry test results of 2+ or 3+.
In addition, vidicetizumab has also been recognized by the China Food and Drug Administration and the US FDA for breakthrough treatment three times, of which the treatment of urinary intestinal carcinoma has been recognized by the China Food and Drug Administration and the US FDA for breakthrough treatment. Rongchang biological product pipeline also has three ADC drugs, namely RC88, RC108 and RC118, although the research and development is still in the early stages, the fastest progress of RC118 is only in November 2021, in Australia to complete the first patient enrollment in the Phase I clinical trial, but Rongchang Biologics' successful experience in the field of ADC drugs is bound to make it more effective with half the effort and continue the "trump card" style in the field of ADC drugs in China.
Image source: Rongchang Bio's official website
Resources:
[1] Ping An Securities
[2] Southwest Securities
[3] Rongchang Bio's official website
[4] Hengrui Pharmaceutical official website
Source: Scy Club
Author: Zhao Yanwu
Typography: Joyce
Editor-in-Charge: Adam