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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 362 drug applications between 8 May 2025 and 14 May 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 99, covering 68 drug names.

2025/05/08 – 2025/05/14

Period
2025/05/08 to 2025/05/14, 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
362
Drugs with new generic filings (by drug name, de-duplicated)
68
Accepted this week, now under review
42

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

362filings, 99 of them generic

By application type

Application typeFilings
Supplement171
Generic99
New drug65
Import20
Unspecified6
Import re-registration1

By drug type

Drug typeFilings
Chemical drug217
TCM70
Therapeutic biologic69
Prophylactic biologic4
Biologic2

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

68 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Minoxidil Liniment6352
2Penicillin G Sodium For Injection612
3Metoclopramide Hydrochloride Injection336
4Riociguat Tablets314
5Brexpiprazole Tablets3131
6氯雷他定糖浆 · No verified English name227
7黄体酮注射液(Ⅱ) · No verified English name222
8Nintedanib Esilate Soft Capsules216
9Carboplatin Injection2110
10Orlistat Capsules218

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

216 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shenyang Dong Xin Pharma Co., Ltd. romanized12120
2Jiangxi Qing Feng Pharma Co., Ltd. romanized1090
3AstraZeneca AB870
4Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized620
5Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized620
6Sanofi Winthrop Industrie610
7Chengdu Jing Fu Pharmaceuticals Technology Co., Ltd. romanized616
8Shanxi Huang He Zhong Yao Co., Ltd. romanized550
9Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized540
10Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized530

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

128 this week

AcceptedDrugApplicants
2025/05/14Import · Class 3.1 达雷妥尤单抗注射液(皮下注射) · No verified English nameJXSS2500061 Janssen-Cilag International NV; Cilag AG; Johnson & Johnson Pharmaceutical Ltd.
2025/05/14Import · Class 1 AZD9793 · No verified English nameJXSL2500075 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/05/14Generic · Class 3 Methocarbamol InjectionCYHS2501745 CSPC OUYI PHARMACEUTICAL CO., LTD.
2025/05/14Generic · Class 3 Progesterone InjectionCYHS2501743 Hangzhou Fu Ou Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2025/05/14Generic · Class 3 Bifonazole SolutionCYHS2501742 Chongqing Wan Lin Biopharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2025/05/14Generic · Class 3 Metoclopramide Hydrochloride InjectionCYHS2501741 Hainan Ying Da Run Ze Pharma Co., Ltd. romanized; Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized
2025/05/14Generic · Class 3 Olprinone Hydrochloride InjectionCYHS2501740 Yunnan Yao Ke Yuan Biopharmaceuticals Co., Ltd. romanized; Chu Xiong He Chuang Pharma Co., Ltd. romanized
2025/05/14Generic · Class 3 Thioctic Acid TabletsCYHS2501735 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2025/05/14Generic · Class 3 Metoclopramide Hydrochloride InjectionCYHS2501734 Shenyang Guang Da Pharmaceutical Co., Ltd. romanized; Shenyang Shuang Ding Pharmaceutical Co., Ltd. romanized
2025/05/14Generic · Class 3 Bromhexine Hydrochloride Oral SolutionCYHS2501730 Beijing Min Kang Bai Cao Pharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd
2025/05/14Generic · Class 3 Metronidazole TabletsCYHS2501729 Hainan Hai Shen Tong Zhou Pharmaceutical Co., Ltd. romanized
2025/05/14Generic · Class 3 Metronidazole Vaginal GelCYHS2501728 Hubei Wu Shi Pharma Co., Ltd. romanized
2025/05/14Generic · Class 3 Relugolix TabletsCYHL2500092 Jiangsu Lianhuan Pharmaceutical Co.,Ltd.
2025/05/14New drug · Class 1 注射用HS-20093 · No verified English nameCXSL2500380 Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized
2025/05/14New drug · Class 1 SIBP-A16 注射液 · No verified English nameCXSL2500379 Shanghai Bio Zhi Pin Research Institute Co., Ltd. romanized
2025/05/14New drug · Class 1 注射用TQB2103 · No verified English nameCXSL2500378 Shanghai Zheng Da Tian Qing Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2025/05/14New drug · Class 1 TQB2868注射液 · No verified English nameCXSL2500377 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2025/05/14New drug · Class 1 吡洛西利片 · No verified English nameCXHS2500051 Xuan Zhu Bio Technology Co., Ltd. romanized; Kai Lai Ying Sheng Ming Ke Xue Technology (Tianjin) Co., Ltd. romanized
2025/05/14New drug · Class 1 Safusidenib胶囊 · No verified English nameCXHL2500473 Bao Yuan Biopharmaceuticals Technology (Hangzhou) Co., Ltd. romanized
2025/05/14New drug · Class 1 WJ47DZ片 · No verified English nameCXHL2500472 Nanjing Yi Jing Biopharmaceuticals Technology Co., Ltd. romanized
2025/05/14New drug · Class 1 WJ47DZ片 · No verified English nameCXHL2500471 Nanjing Yi Jing Biopharmaceuticals Technology Co., Ltd. romanized
2025/05/14New drug · Class 1 HRS-5041片 · No verified English nameCXHL2500470 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/05/14New drug · Class 1 HRS-5041片 · No verified English nameCXHL2500469 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/05/14New drug · Class 1 HRS-5041片 · No verified English nameCXHL2500468 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/05/14New drug · Class 1 HRS-2162注射液 · No verified English nameCXHL2500467 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/05/14New drug · Class 1 HRS-5041片 · No verified English nameCXHL2500466 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/05/14New drug · Class 1 PTT-501片 · No verified English nameCXHL2500465 Beijing Yan Ming Bio Technology Co., Ltd. romanized
2025/05/14New drug · Class 1 PTT-501片 · No verified English nameCXHL2500464 Beijing Yan Ming Bio Technology Co., Ltd. romanized
2025/05/14New drug · Class 1 KW-040注射液 · No verified English nameCXHL2500463 Beijing Kai Yin Technology Co., Ltd. romanized
2025/05/13Import · Class 3.1 度普利尤单抗注射液 · No verified English nameJXSS2500060 Sanofi Winthrop Industrie; Sanofi (China) Investment Co. Ltd.

98 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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