The world's first CD19 ADC received positive comments from CHMP, expanding the commercial territory!

It is expected that the approval decision of the European Medicines Agency (EMA) will be made

The positive opinion from CHMP is based on data from the Phase 2 transnational single-arm clinical trial LOTIS-2, which included a total of 145 patients with

In April 2021, the FDA approved Zynlonta's marketing application based on the above trial data for the treatment of adult patients with relapsed or refractory DLBCL after at least two or more systemic treatments

Zynlonta is formed

In September 2021, the European Commission awarded Zylonta the title of orphan drug; In July 2022, Oulu Pharmaceuticals, a joint venture created by Urun Pharmaceutical and ADC Therapeutics, announced the completion of the first patient administration

At present, 14 ADC drugs have been approved for marketing worldwide, involving 11 targets, and the indications cover solid tumors and hematological tumors
.

There are more than 400 ADC projects in research, of which more than 200 have entered the clinical stage and nearly 60 candidate products have entered the clinical stage in China
.

Among them, many projects, including TAA013 of Dongyao Pharmaceutical, SKB264 of Colombotai, and SHR-A1811 of Hengrui Pharmaceutical, have entered the phase 3 clinical trial stage
.

The domestic ADC track can be described as enthusiastic
.

▲ ADC drugs have been marketed worldwide

(Image source: Reference 2)

ADC drugs are not as narrow as
PD-(L)1.

From the perspective of the ADCs that have been listed, the target difference is high, and the indications are more diverse
.

From the perspective of research and development, ADC is composed of antibodies, hymens, and loads, and the optimization of each part will make the candidate drug grow exponentially, which also makes ADC full of imagination
.

Under the continuous iteration and update of technology, DS-8201 is a blockbuster product that has brought different thinking
to the industry.

On the one hand, in other targets and indications, there is a possibility of the birth of the next "DS-8201", who develops it first will occupy a greater advantage in the fierce competition; On the other hand, in view of the existence of DS-8201, the safety problem of interstitial pneumonia that may cause death is "hard", and the safety is broken under the premise of ensuring efficacy, and may become the new owner
of HER2 ADC.

In addition, some new ADC candidates are emerging, such as dual-epitope or dual-target ADCs, ADCs that use two different payload combinations, and so on
.

At present, ADC drugs are still facing many challenges
in clinical research and development, such as the complexity of pharmacokinetics, insufficient tumor targeting and payload release, immunogenicity, and drug resistance.

In addition, under the high enthusiasm for research and development, more and more projects have entered the clinic, which also urgently requires relevant institutions to formulate regulations and guidelines for the research and development of ADC drugs
.

Although China already has a series of policies such as "Management Indicators for Clinical Rational Application of Antitumor Drugs (2021 Edition)", "14th Five-Year" Pharmaceutical Industry Development Plan, and "14th Five-Year" Bioeconomic Development Plan, a series of policies to encourage the development of
bioinnovative drugs.

However, there is still a lack of more professional and targeted guidelines in the ADC field
.

On September 15, 2022, CDE issued a notice on the public solicitation of opinions on the Technical Guidelines for the Clinical Development of Anti-tumor Antibody Conjugated Drugs, aiming to make suggestions on issues requiring special attention in the clinical development of antibody-coupled anti-tumor drugs and guide enterprises to carry out more scientific clinical research and development
.

This also means that the state pays more attention to and encourages the healthy development
of the ADC industry.

summary

Whether it is a foreign Zynlonta is one step closer to the European listing, or the rapid development of domestic ADCs and the continuous improvement of
policies.

In fact, it is all for the ultimate goal - to make ADC drugs reach more patients
.

We also look forward to people in various industries working together to build a healthier ADC ecosystem and help biomedicine develop
better.
"

Resources:

1.
——List of recent hot events——

▼On September 21, Merck China Biosafety Testing Center was opened