YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 423 drug applications between 8 August 2024 and 14 August 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 135, covering 82 drug names.

2024/08/08 – 2024/08/14

Period
2024/08/08 to 2024/08/14, 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
423
Drugs with new generic filings (by drug name, de-duplicated)
82
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

423filings, 135 of them generic

By application type

Application typeFilings
Supplement176
Generic135
New drug73
Unspecified18
Import re-registration13
Import8

By drug type

Drug typeFilings
Chemical drug299
TCM53
Therapeutic biologic49
Prophylactic biologic12
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

82 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
4Ketorolac Tromethamine Injection424
5Pioglitazone and Metformin Hydrochloride Tablets3310
6Bisoprolol Fumarate and Amlodipine Besylate Tablets339
7Sacubitril Valsartan Sodium Tablets3170
8Cefoperazone Sodium and Sulbactam Sodium for Injection3114
9Metformin Hydrochloride Extended-release Tablets3110
10Labetalol Hydrochloride Injection314

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

239 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1NAPP PHARMACEUTICALS LIMITED910
2Hua Bei Pharmaceutical Jin Tan Bio Technology Co., Ltd. romanized810
3Novo Nordisk A/S730
4Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized730
5Shanxi Hua Kang Pharma Co., Ltd. romanized640
6CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD640
7Henan Hua Feng Pharmaceutical Co., Ltd. romanized630
8Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized620
9Shanghai Pharmaceuticals Group Qingdao Guo Feng Pharma Co., Ltd. romanized550
10Pfizer Inc.540

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

139 this week

AcceptedDrugApplicants
2024/08/14Generic · Class 3 Ketorolac Tromethamine InjectionCYHS2402644 Zhongshan Wanhan Pharmaceuticals Co., Ltd.
2024/08/14Generic · Class 3 Ketorolac Tromethamine InjectionCYHS2402643 Zhongshan Wanhan Pharmaceuticals Co., Ltd.
2024/08/14Generic · Class 3 Furosemide InjectionCYHS2402642 Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized
2024/08/14Generic · Class 3 Carbazochrome Sodium Sulfonate InjectionCYHS2402638 Jiangsu Wu Zhong Pharmaceuticals Group Co., Ltd. Suzhou Pharmaceutical Factory romanized
2024/08/14Generic · Class 3 Progesterone InjectionCYHS2402629 Anhui Chang Jiang Pharma Co., Ltd. romanized
2024/08/14Generic · Class 3 Pioglitazone and Metformin Hydrochloride TabletsCYHS2402628 Anhui Pioneer Pharmaceutical Co., Ltd
2024/08/14Generic · Class 3 Trazodone Hydrochloride TabletsCYHS2402625 Hua Yi Tai Kang Pharma Co., Ltd. romanized
2024/08/14Generic · Class 3 Trazodone Hydrochloride TabletsCYHS2402624 Hua Yi Tai Kang Pharma Co., Ltd. romanized
2024/08/14New drug · Class 1 XKH001注射液 · No verified English nameCXSL2400541 Zhejiang Xin Kang He Biopharmaceuticals Technology Co., Ltd. romanized; Beijing Xin Kang He Biopharmaceuticals Technology Co., Ltd. romanized
2024/08/14New drug · Class 1 JCXH-211注射液 · No verified English nameCXSL2400540 Jia Chen Xi Hai (Hangzhou) Bio Technology Co., Ltd. romanized
2024/08/14New drug · Class 1 HRS-6209胶囊 · No verified English nameCXHL2400831 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/08/14New drug · Class 1 HRS-6209胶囊 · No verified English nameCXHL2400830 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/08/14New drug · Class 1 HRS-6209胶囊 · No verified English nameCXHL2400829 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/08/14New drug · Class 1 HRS-6209胶囊 · No verified English nameCXHL2400828 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/08/14New drug · Class 1 LPM682000012片 · No verified English nameCXHL2400827 Shandong Lv Ye Pharmaceutical Co., Ltd. romanized
2024/08/14New drug · Class 1 LPM682000012片 · No verified English nameCXHL2400826 Shandong Lv Ye Pharmaceutical Co., Ltd. romanized
2024/08/14New drug · Class 1 LPM682000012片 · No verified English nameCXHL2400825 Shandong Lv Ye Pharmaceutical Co., Ltd. romanized
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

109 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.

Subscribe to the weekly

No account needed.

The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.

A text version of this report, weekly, in the language you subscribe in. You will receive one confirmation email first; sending starts only after you click its link. Every issue carries an unsubscribe link.