On July 17th, according to the 'Kechuang board daily' (Reporter: Zheng Bingxun), Zai Lab (9688.HK, ZLZB.O) and cooperative enterprise Argenx released a press release stating that on the 16th, the National Medical Products Administration (NMPA) received the biological product listing application for 'Edaravone alpha injection (subcutaneous injection)', and it can be used in conjunction with conventional therapeutic drugs to treat adult generalized myastenia gravis (gMG) patients who are acetylcholine receptor (AChR) antibody-positive.

This means that Edaravone alpha injection (subcutaneous injection) has become the first subcutaneous injection preparation approved by the NMPA for the treatment of gMG in China.

Previously, Edaravone alpha injection (intravenous injection) was already approved for listing in June 2023, and it is also used to treat adult gMG patients who are AChR antibody-positive. In September of the same year, the product was officially commercialized in mainland China, and at the end of that year, this indication was included in the national medical insurance drug list.

In the United States, European Union, Japan and other countries and regions, Edaravone subcutaneous injection was approved for listing ahead of China.

It is reported that Edaravone subcutaneous injection will be administered in a single subcutaneous injection (fixed dose of 1000mg) within 30-90 seconds, once a week for four consecutive weeks for one treatment cycle. The Phase III clinical study ADAPT-SC showed that Edaravone subcutaneous injection is clinically beneficial and safe, which will provide more treatment flexibility and selectivity for gMG patients.

It is estimated that there are approximately 0.17 million adult generalized myasthenia gravis (gMG) patients in China, of whom as many as 85% of patients are acetylcholine receptor (AChR) antibody-positive.

Due to increased patient accessibility, approximately 2,700 patients received Edaravone intravenous infusion treatment in the first quarter of 2024, creating sales revenue of $13.2 million for the product. Edaravone was commercialized from September to the end of the year 2023, achieving sales of $10.011 million.

"Kechuang board daily" asked Zai Lab about the pricing difference and sales channel layout of subcutaneous injection Edaravone compared to intravenous injection Edaravone, and the company replied, "The current pricing of Woorijia (subcutaneous injection Edaravone trade name) has not been disclosed yet, but it has increased the treatment flexibility for patients and is expected to further simplify the treatment plan. In the future we will strive to make treatment more accessible."

The other party further revealed that as the national negotiations are being accelerated, Wowijia (intravenous injection Edaravone trade name) has entered the "Double Channel" in multiple places and can be sold through designated medical institutions and designated retail pharmacies, and is also concurrently included in medical insurance payment. "It is expected that Wowijia's full-year revenue in 2024 will reach $70 million," the other party said. However, about the sales expectations of Woorijia, the other party did not disclose it.

Currently, in addition to Edaravone, Zai Lab has four other products on the market for sales. In the first quarter of 2024, Zai Lab achieved revenue of $87.149 million, of which the total revenue from drugs was approximately $87.1 million, an increase of 39% year-on-year. However, since Zai Lab has multiple pipeline products in clinical Stage III for tumors and autoimmune disorders, research and development expenses are still high, reaching $54.645 million in the first quarter of 2024, up 12.74% from the same period last year.

Currently, Zai Lab has not yet achieved profitability. In the first quarter of 2024, Zai Lab reported a net loss of $53.5 million, an increase of 8.96% compared to the same period in 2023 when the net loss was $49.1 million. At the same time, Zai Lab had a cash and cash equivalents balance on hand of $651 million.

It can be seen that Zai Lab is accelerating the market launch of new products and has achieved multiple important milestones after its first-quarter report in 2024 was released.

This includes: Ripretinib received NMPA approval for the treatment of adult patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC), Shubata tosylate-deurobotan tosylate was approved for the treatment of hospital-acquired bacterial pneumonia caused by Bauman-acetic acid and other sensitive isolates in patients who are older than 18 years of age, as well as ventilator-associated bacterial pneumonia.

Further disclosure from Zai Lab enterprise personnel reveals that multiple products are expected to be approved for listing in the next 5 years, such as TIVDAK for cervical cancer, Bemarituzumab for gastric cancer, KarXT for schizophrenia, etc. At the same time, they will also expand the new indications for listed products, including the supplemental new drug application of EGMED for CIDP (chronic inflammatory demyelinating polyneuropathy), which has already been submitted for review by the drug regulatory agency.