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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 398 drug applications between 7 August 2024 and 13 August 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 122, covering 77 drug names.

2024/08/07 – 2024/08/13

Period
2024/08/07 to 2024/08/13, 7 days inclusive
Data as of
2026/11/13 06:00
Cached records
94,806 acceptance records, 11,656 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
398
Drugs with new generic filings (by drug name, de-duplicated)
77
Accepted this week, now under review
2

DefinitionAcceptance numbers accepted this week that still appear on CDE's under-review list at the data cutoff; counted by acceptance date from the daily full pull of that list, independent of snapshot history.

Names with a public page are linked.

New acceptances this week

By application type and drug type

398filings, 122 of them generic

By application type

Application typeFilings
Supplement154
Generic122
New drug70
Import22
Unspecified18
Import re-registration12

By drug type

Drug typeFilings
Chemical drug293
Therapeutic biologic46
TCM39
Biologic10
Prophylactic biologic10

DefinitionAcceptance numbers whose acceptance date falls in this week; application type and drug type are the CDE list's own text, with empty values shown as “Unspecified”.

Most new generic filings, by drug

77 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1生理氯化钠溶液 · No verified English name5117
2Dapoxetine Hydrochloride Tablets4220
3苯磺酸左氨氯地平片 · No verified English name4245
4Bisoprolol Fumarate and Amlodipine Besylate Tablets339
5Sacubitril Valsartan Sodium Tablets3170
6Cefoperazone Sodium and Sulbactam Sodium for Injection3114
7Metformin Hydrochloride Extended-release Tablets3110
8Labetalol Hydrochloride Injection314
9Pioglitazone and Metformin Hydrochloride Tablets2210
10氯化钙注射液 · No verified English name226

DefinitionThis week's acceptance numbers with application type “Generic”, grouped by identical drug name; filing companies are de-duplicated by first applicant; under review, all years = acceptance numbers for that name, from any year, still on the CDE under-review list. Top 10 by filings, then companies.

Most new acceptances, by company

227 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Boehringer Ingelheim International GmbH1410
2NAPP PHARMACEUTICALS LIMITED910
3Hua Bei Pharmaceutical Jin Tan Bio Technology Co., Ltd. romanized810
4Novo Nordisk A/S730
5Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized730
6CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD640
7Pfizer Inc.540
8Henan Hua Feng Pharmaceutical Co., Ltd. romanized530
9Hebei Dao En Pharma Co., Ltd. romanized515
10Shenyang Hong Yao Group Co., Ltd. romanized440

DefinitionThis week's acceptance numbers grouped by first applicant; drugs are de-duplicated by drug name; “Generic” counts filings with application type “Generic”. Top 10 by filings.

Under-review list changes

Compared across this platform's snapshots of the under-review list

Data collected since 2026/10/22. There is not enough snapshot history for this week yet; counts of filings entering and leaving review start with the next complete week.

DefinitionEntered review = acceptance numbers seen for the first time in this platform's under-review snapshots this week, excluding the baseline records of the first snapshot day (2026/10/22). Left review = acceptance numbers whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.

Class 3 and new-drug acceptances

152 this week

AcceptedDrugApplicants
2024/08/13Import · Class 1 马塔西单抗注射液 · No verified English nameJXSS2400065 Pfizer Inc.; Pfizer Manufacturing Belgium NV; Pfizer Investment Co. Ltd.
2024/08/13Import · Class 1 CID-103注射液 · No verified English nameJXSL2400148 CASI Pharmaceuticals Inc.; CASI Pharmaceuticals (China) Co. Ltd.
2024/08/13Import · Class 2.4 盐酸奎扎替尼片 · No verified English nameJXHL2400200 Daiichi Sankyo Inc.; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD.
2024/08/13Import · Class 2.4 盐酸奎扎替尼片 · No verified English nameJXHL2400199 Daiichi Sankyo Inc.; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD.
2024/08/13Generic · Class 3 Potassium Chloride InjectionCYHS2402622 Xu Bi Di Pharma (Hebei) Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized
2024/08/13Generic · Class 3 Hydrocortisone Sodium Succinate for InjectionCYHS2402621 Chongqing Shi Li De Pharmaceuticals Technology Co., Ltd. romanized; Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanized
2024/08/13Generic · Class 3 Hydrocortisone Sodium Succinate for InjectionCYHS2402620 Chongqing Shi Li De Pharmaceuticals Technology Co., Ltd. romanized; Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanized
2024/08/13Generic · Class 3 Diflunisal TabletsCYHS2402617 Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/08/13Generic · Class 3 Sodium Thiosulfate InjectionCYHS2402610 Sichuan Shang Shan Liu Jing Pharmaceuticals Technology Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.
2024/08/13Generic · Class 3 Sodium Thiosulfate InjectionCYHS2402609 Sichuan Shang Shan Liu Jing Pharmaceuticals Technology Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.
2024/08/13Generic · Class 3 Ketorolac Tromethamine InjectionCYHS2402606 Zhejiang Feng Hua Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/08/13Generic · Class 3 Ketorolac Tromethamine InjectionCYHS2402605 Zhejiang Feng Hua Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/08/13Generic · Class 3 维生素B6注射液 · No verified English nameCYHS2402604 Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized
2024/08/13Generic · Class 3 帕立骨化醇软胶囊 · No verified English nameCYHL2400164 Nanjing Hai Rong Pharmaceuticals Technology Co., Ltd. romanized
2024/08/13New drug · Class 1 注射用TQB2029 · No verified English nameCXSL2400539 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2024/08/13New drug · Class 2.2 阿得贝利单抗注射液 · No verified English nameCXSL2400538 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2024/08/13New drug · Class 1 注射用DB-1305 · No verified English nameCXSL2400537 Ying En Biopharmaceutical (Suzhou) Co., Ltd. romanized
2024/08/13New drug · Class 1 PM8002注射液 · No verified English nameCXSL2400536 Pu Mi Si Bio Technology (Zhuhai) Co., Ltd. romanized
2024/08/13New drug · Class 1 注射用BGB-B3227 · No verified English nameCXSL2400535 Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized
2024/08/13New drug · Class 1 KSD-101注射液 · No verified English nameCXSL2400534 Zhong Shan Heng Sai Bio Technology Co., Ltd. romanized
2024/08/13New drug · Class 1 靶向CD19非病毒PD1定点整合CAR-T细胞注射液 · No verified English nameCXSL2400533 Shanghai Bang Yao Bio Technology Co., Ltd. romanized
2024/08/13New drug · Class 1 利厄替尼片 · No verified English nameCXHS2400074 Jiangsu Ao Sai Kang Pharma Co., Ltd. romanized
2024/08/13New drug · Class 1 ZX-7101A片 · No verified English nameCXHL2400824 Nanjing Zheng Xiang Pharmaceuticals Co., Ltd. romanized
2024/08/13New drug · Class 1 TQB3616胶囊 · No verified English nameCXHL2400823 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2024/08/13New drug · Class 1 TQB3616胶囊 · No verified English nameCXHL2400822 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2024/08/13New drug · Class 1 TQB3912片 · No verified English nameCXHL2400821 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2024/08/13New drug · Class 1 TQB3912片 · No verified English nameCXHL2400820 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2024/08/13New drug · Class 1 YKYY015注射液 · No verified English nameCXHL2400819 Hangzhou Tian Long Pharma Co., Ltd. romanized
2024/08/13New drug · Class 1 RDSY1801肠溶胶囊 · No verified English nameCXHL2400818 Shanghai De Jian Cong He Biopharmaceuticals Technology Co., Ltd. romanized
2024/08/13New drug · Class 1 RDSY1801肠溶胶囊 · No verified English nameCXHL2400817 Shanghai De Jian Cong He Biopharmaceuticals Technology Co., Ltd. romanized

122 more not listed (at most 30 rows).

DefinitionThis week's acceptance numbers with application type “New drug”, or registration applications whose class starts with 1, 2 or 3 (supplements and re-registrations excluded); newest first, at most 30 rows.

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