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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 315 drug applications between 21 June 2025 and 27 June 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 80, covering 56 drug names.

2025/06/21 – 2025/06/27

Period
2025/06/21 to 2025/06/27, 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
315
Drugs with new generic filings (by drug name, de-duplicated)
56
Accepted this week, now under review
51

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

315filings, 80 of them generic

By application type

Application typeFilings
Supplement154
Generic80
New drug50
Import15
Import re-registration13
Unspecified3

By drug type

Drug typeFilings
Chemical drug183
TCM76
Therapeutic biologic53
Prophylactic biologic2
Biologic1

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

56 drugs with new generic filings; top 10 listed

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

217 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Heilongjiang Jun An Pharma Group Hong Xiang Pharmaceutical Co., Ltd. romanized990
2Amgen Inc.720
3SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED432
4Guangdong He Xiang Biopharmaceuticals Co., Ltd. romanized430
5Roche Pharma (Schweiz) AG420
6Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized410
7Sichuan He Zheng Pharmaceutical Co., Ltd. romanized330
8Da Tong Shi Li Qun Pharma Co., Ltd. romanized330
9Hunan Tai Yang Pharma Co., Ltd. romanized330
10Tong Hua Ji Tong Pharma Co., Ltd. romanized330

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

88 this week

AcceptedDrugApplicants
2025/06/27Generic · Class 3 Hydrocortisone Sodium Succinate for InjectionCYHS2502300 Hunan Chun Jian Pharmaceutical Technology Co., Ltd. romanized; Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized
2025/06/27Generic · Class 3 Amisulpride Oral SolutionCYHS2502294 Jiangsu Bei Jia Pharmaceutical Co., Ltd. romanized
2025/06/27Generic · Class 3 Ebastine Oral SolutionCYHS2502291 Hainan Si Da Pharmaceutical Co., Ltd. romanized
2025/06/27New drug · Class 3.3 重组人促卵泡激素注射液 · No verified English nameCXSS2500071 Chengdu Jing Ze Biopharmaceutical Co., Ltd. romanized
2025/06/27New drug · Class 3.3 重组人促卵泡激素注射液 · No verified English nameCXSS2500070 Chengdu Jing Ze Biopharmaceutical Co., Ltd. romanized
2025/06/27New drug · Class 1 注射用QLC5508 · No verified English nameCXSL2500519 Qilu Pharmaceutical Co., Ltd.
2025/06/27New drug · Class 2.2 培集成干扰素α-2注射液 · No verified English nameCXSL2500518 Beijing Kai Yin Technology Co., Ltd. romanized
2025/06/27New drug · Class 1 QLH12016胶囊 · No verified English nameCXHL2500625 Qilu Pharmaceutical Co., Ltd.
2025/06/27New drug · Class 1 QLH12016胶囊 · No verified English nameCXHL2500624 Qilu Pharmaceutical Co., Ltd.
2025/06/27New drug · Class 1 ICP-332片 · No verified English nameCXHL2500621 Guangzhou Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized
2025/06/26Import · Class 3.1 注射用A型肉毒毒素 · No verified English nameJXSS2500098 AbbVie Limited; Allergan Pharmaceuticals Ireland; Allergan Information Consulting (Shanghai) Co. Ltd.
2025/06/26Import · Class 3.1 注射用A型肉毒毒素 · No verified English nameJXSS2500097 AbbVie Limited; Allergan Pharmaceuticals Ireland; Allergan Information Consulting (Shanghai) Co. Ltd.
2025/06/26Import · Class 3.1 注射用A型肉毒毒素 · No verified English nameJXSS2500096 AbbVie Limited; Allergan Pharmaceuticals Ireland; Allergan Information Consulting (Shanghai) Co. Ltd.
2025/06/26Generic · Class 3 Paracetamol and Ibuprofen TabletsCYHS2502290 Jian Min Pharma Group Co., Ltd. romanized
2025/06/26Generic · Class 3 Procaterol Hydrochloride GranulesCYHS2502289 Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized
2025/06/26Generic · Class 3 Folic Acid TabletsCYHS2502288 Chi Feng Gu De Pharma Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd
2025/06/26Generic · Class 3 Procaterol Hydrochloride GranulesCYHS2502287 Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized
2025/06/26Generic · Class 3 Famotidine InjectionCYHS2502284 Nanjing Chen Gong Pharmaceutical Co., Ltd. romanized
2025/06/26Generic · Class 3 Indocyaninegreen for InjectionCYHS2502283 Zhuhai Qian Lie Pharma Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.
2025/06/26Generic · Class 3 Paracetamol and Ibuprofen TabletsCYHS2502281 Huayi Pharmaceuticals (Anhui) Co., Ltd.
2025/06/26New drug · Class 1.1 红七片 · No verified English nameCXZL2500041 Beijing Hua Yi Shen Nong Pharmaceuticals Technology Co., Ltd. romanized; Beijing University romanized
2025/06/26New drug · Class 2.2 信迪利单抗注射液 · No verified English nameCXSS2500069 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2025/06/26New drug · Class 1 舒瑞基奥仑赛注射液 · No verified English nameCXSS2500068 Kai Xing Sheng Ming Technology (Shanghai) Co., Ltd. romanized; Shanghai Ke Ji Pharmaceutical Co., Ltd. romanized
2025/06/26New drug · Class 1 注射用TQB2934(皮下注射) · No verified English nameCXSL2500517 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2025/06/26New drug · Class 1 ZL-1109注射液 · No verified English nameCXSL2500516 Zai Ding Pharmaceuticals (Shanghai) Co., Ltd. romanized
2025/06/26New drug · Class 1 IM96嵌合抗原受体T细胞注射液(IM96 CAR-T细胞注射液) · No verified English nameCXSL2500515 Shandong Jin Sai Bio Technology Co., Ltd. romanized
2025/06/26New drug · Class 1 TP1001 片 · No verified English nameCXHL2500623 Sheng Yuan Ze Tong (Shanghai) Pharmaceuticals Co., Ltd. romanized
2025/06/26New drug · Class 1 TP1001 片 · No verified English nameCXHL2500622 Sheng Yuan Ze Tong (Shanghai) Pharmaceuticals Co., Ltd. romanized
2025/06/26New drug · Class 2.4 戊二酸利那拉生酯胶囊 · No verified English nameCXHL2500620 Shanghai Sheng Nuo Pharmaceuticals Technology Co., Ltd. romanized
2025/06/26New drug · Class 2.4 戊二酸利那拉生酯胶囊 · No verified English nameCXHL2500619 Shanghai Sheng Nuo Pharmaceuticals Technology Co., Ltd. romanized

58 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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