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China has Entered the Era of Tumor Immunotherapy: Updates on the R&D Progress of Anti-PD-(L)1 Antibodies

march 06, 2019 By 1℃

2018 was the first year of the tumor immunotherapy in China. The new era of tumor immunotherapy has begun in China with the marketing of anti-PD-(L)1 antibodies represented by Opdivo, Keytruda, and Tuoyi, etc. in China. The development progress of the anti-PD-(L)1 products are analyzed here in this article.

Tumor Immunotherapy

I. China accelerating entry into the era of tumor immunotherapy: 4 anti-PD-(L)1 antibodies approved

BMS’ anti-PD-1 monoclonal antibody: Opdivo was the first of the 4 approved for marketing on June 15, 2018, which is approved to treat EGFR/ALK- patients who have locally advanced or metastatic non-small cell lung cancer (NSCLC) with progression on or intolerance to prior platinum-based chemotherapy. China has since entered the era of tumor immunotherapy.

4 anti-PD-1 monoclonal antibodies have so far been approved in China, and 3 anti-PD-(L)1 antibodies are in the marketing review stage.

Wherein:

Among the marketed anti-PD-1 monoclonal antibodies:

1. There are 2 imported drugs and 2 Chinese-produced drugs;

2. 3 indications are covered, separately being NSCLC, melanoma, and Hodgkin’s lymphoma (HL);

3. The review time was about 165-272 days;

4. In terms of price, the annual cost of imported drugs is RMB150,000-200,000, while that of Chinese-produced drugs is lower than RMB100,000 (price after drug donation/assistance).

Region

Opdivo

Keytruda

Tuoyi

Tyvyt

China, RMB

100mg/10mL: 9,260; 40mg/4mL: 4,591

100mg/4mL: 17,918

240mg/6ml: 7,200

100mg/10mL

Hong Kong, HKD

100mg/10mL: 20,000; 40mg/4mL: 9,500

100mg/4mL: 30,000

N/A

N/A

U.S., USD

100mg/10mL: 2,500

100mg/4mL: 4,800

N/A

N/A

Usage and dosage

3mg/kg, once every two weeks, intravenous drip

2mg/kg, once every three weeks, intravenous drip

3mg/kg, once every two weeks, intravenous drip

200mg, once every three weeks, intravenous drip

50-60kg patient

RMB360,000-479,000 / year

RMB305,000 / year

RMB187,000 / year

Not published

Drug donation/assistance

“6+7” drug donation

“3+3” drug donation for low-income patients; 24 months of free use for patients entitled to the subsistence allowances

“4+4” drug donation

Not available

Opdivo assistance program:

See the Assistance Program of Opdivo Patient Assistance Project of Cancer Foundation of China

http://www.cfchina.org.cn/show.php?contentid=1717

Keytruda assistance program:

MSD has conducted the charitable aid activity for malignant melanoma patients in association with China Primary Health Care Foundation (CPHCF). See the following for the details

http://smzy.ilvzhou.com

Tuoyi assistance program:

Every Step of the Way—Bethune Tuoyi Public Donation Project: see the following for the details

http://www.bjbqejjh.org.cn/news-detail.asp?id=1202

II. The “Pacific storm” of AstraZeneca to arrive: Durvalumab applied for marketing

In addition to the 4 anti-PD-(L)1 monoclonal antibodies marketed, many other anti-PD-(L)1 monoclonal antibodies are expected to be approved for marketing in China in 2019.

There are still 3 antibodies under marketing review in China at present:

1. 2 Chinese-produced pharmaceutical products, and 1 imported pharmaceutical product;

2. The indications are HL and stage III NSCLC;

3. The review cycle of Hengrui Medicine’s camrelizumab is longer than similar products.

Among the 3 drugs under marketing review:

1. The indication applied for Hengrui Medicine’s camrelizumab is HL. According to the 2018 financial report of Hengrui medicine, accumulatively RMB397 million has been invested in the relevant project, the progress of the indications of liver cancer and esophagus cancer has been smooth, and the company has set up a sales team for the marketing of the product. The review time of the drug has exceeded that of similar products, however, in my opinion, camrelizumab is still likely to be approved for marketing, which is expected to be at the end of Mar. 2019.

2. With regard to AstraZeneca’s durvalumab, according to its financial report, the indication applied therefor is unresectable stage III NSCLC without disease progression after chemotherapy, and the approval of this big indication has greatly driven the global market performance of durvalumab. Durvalumab will continue to add luster to AstraZeneca’s performance in China after it enters China through the indication of stage III NSCLC.

Pharmaceutical product

Target

Company

Progress in China

Imported / Chinese-produced

Indication

Review time (day)

Nivolumab

PD-1

BMS

Marketed

Imported

NSCLC

226

Pembrolizumab

PD-1

MSD

Marketed

Imported

Melanoma

165

Toripalimab

PD-1

Junshi Biosciences

Marketed

Chinese-produced

Melanoma

272

Sintilimab

PD-1

Innovent

Marketed

Chinese-produced

HL

252

Camrelizumab

PD-1

Hengrui Medicine

Applied for production

Chinese-produced

HL

303, expected to be approved in 2019Q1

Tislelizumab

PD-1

BeiGene

Applied for production

Chinese-produced

HL

167, expected to be approved in 2019Q2

Durvalumab

PD-L1

AstraZeneca

Applied for production

Imported

Stage III NSCLC

56, expected to be approved in 2019Q3

China has Entered the Era of Tumor Immunotherapy.

Keep Reading:

7 anti-PD-(L)1 antibodies in Phase III clinical trials: lung cancer is still an important indication competed for

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