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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 520 drug applications between 15 October 2025 and 21 October 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 86, covering 63 drug names.

2025/10/15 – 2025/10/21

Period
2025/10/15 to 2025/10/21, 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
520
Drugs with new generic filings (by drug name, de-duplicated)
63
Accepted this week, now under review
119

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

520filings, 86 of them generic

By application type

Application typeFilings
Supplement288
New drug97
Generic86
Unspecified22
Import22
Import re-registration5

By drug type

Drug typeFilings
Chemical drug341
TCM81
Therapeutic biologic78
Biologic15
Prophylactic biologic4
Unspecified1

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

63 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Glucosamine Sulfate Capsules5551
2Vonoprazan Fumarate Tablets4260
3Sacubitril Valsartan Sodium Tablets3270
4LevomilnacipranHydrochloride Extended-release Capsules316
5达普司他片 · No verified English name310
6MOVICOL Ready To Take Sachet, Powder For Oral Solution2216
7呋喃妥因胶囊 · No verified English name214
8Digoxin Injection213
9Imipenem and Cilastatin Sodium for Injection216
10注射用氨曲南/氯化钠注射液 · No verified English name212

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

266 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jilin Sheng Qi Ke Pharma Co., Ltd. romanized64470
2Boehringer Ingelheim International GmbH1120
3Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized910
4Actelion Pharmaceuticals Ltd810
5Terumo Corporation Kofu Factory810
6Hunan Nuo Na Pharmaceuticals Technology Co., Ltd. romanized770
7Heilongjiang Jun An Pharma Group Hong Xiang Pharmaceutical Co., Ltd. romanized660
8Sanofi-Aventis Recherche & Développement630
9Zhongshan Wanhan Pharmaceuticals Co., Ltd.621
10Tong Hua Si Wei Pharma Co., Ltd. romanized550

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

154 this week

AcceptedDrugApplicants
2025/10/21Import · Class 1 注射用PF-08046050 · No verified English nameJXSL2500207 Seagen Inc. a wholly owned subsidiary of Pfizer; Pfizer (Beijing) Research and Development Co. Ltd.
2025/10/21Generic · Class 3 Promethazine Hydrochloride InjectionCYHS2503753 Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; E Mei Shan Tong Hui Pharmaceutical Co., Ltd. romanized
2025/10/21Generic · Class 3 Promethazine Hydrochloride InjectionCYHS2503752 Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; E Mei Shan Tong Hui Pharmaceutical Co., Ltd. romanized
2025/10/21Generic · Class 3 中性低钙腹膜透析液(碳酸氢盐-G1.5%) · No verified English nameCYHS2503750 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2025/10/21Generic · Class 3 MOVICOL Ready To Take Sachet, Powder For Oral SolutionCYHS2503749 Hebei Dong Sheng Ke Yu Pharmaceuticals Technology Co., Ltd. romanized; Anhui Yong Sheng Tang Pharma Co., Ltd. romanized
2025/10/21Generic · Class 3 Diphenhydramine Hydrochloride InjectionCYHS2503744 Guangzhou Rui Er Pharmaceuticals Technology Co., Ltd. romanized; E Mei Shan Tong Hui Pharmaceutical Co., Ltd. romanized
2025/10/21Generic · Class 3 Sodium Nitroprusside InjectionCYHS2503741 Shanghai He Feng Pharmaceutical Co., Ltd. romanized
2025/10/21Generic · Class 3 Paracetamol and Ibuprofen TabletsCYHS2503740 Beijing Foyou Pharma CO.,LTD
2025/10/21Generic · Class 3 贝美前列素涂剂 · No verified English nameCYHL2500189 Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized
2025/10/21New drug · Class 1 GenSci142胶囊 · No verified English nameCXSL2500912 Changchun Jin Sai Pharma Co., Ltd. romanized
2025/10/21New drug · Class 1 GenSci142胶囊 · No verified English nameCXSL2500911 Changchun Jin Sai Pharma Co., Ltd. romanized
2025/10/21New drug · Class 1 GenSci142胶囊 · No verified English nameCXSL2500910 Changchun Jin Sai Pharma Co., Ltd. romanized
2025/10/21New drug · Class 2.4 注射用重组A型肉毒毒素(Sf9细胞,150 kD天然氨基酸序列) · No verified English nameCXSL2500908 Suzhou Ruo Yi Bio Technology Co., Ltd. romanized
2025/10/21New drug · Class 1 PT199 · No verified English nameCXSL2500907 Fan En Shi Pharmaceutical (Beijing) Co., Ltd. romanized
2025/10/21New drug · Class 1 cmRNA1210 注射液 · No verified English nameCXSL2500906 Suzhou Ke Rui Mai De Biopharmaceuticals Technology Co., Ltd. romanized
2025/10/21New drug · Class 1 LPM682000012片 · No verified English nameCXHL2501148 Shandong Lv Ye Pharmaceutical Co., Ltd. romanized
2025/10/21New drug · Class 1 LPM682000012片 · No verified English nameCXHL2501147 Shandong Lv Ye Pharmaceutical Co., Ltd. romanized
2025/10/21New drug · Class 1 LPM682000012片 · No verified English nameCXHL2501146 Shandong Lv Ye Pharmaceutical Co., Ltd. romanized
2025/10/21New drug · Class 2.3 普卢格列汀达格列净二甲双胍缓释片 · No verified English nameCXHL2501145 CSPC OUYI PHARMACEUTICAL CO., LTD.
2025/10/21New drug · Class 2.3 普卢格列汀达格列净二甲双胍缓释片 · No verified English nameCXHL2501144 CSPC OUYI PHARMACEUTICAL CO., LTD.
2025/10/21New drug · Class 1 TM471-1胶囊 · No verified English nameCXHL2501143 Zhi Wei Pharma Technology (Shanghai) Co., Ltd. romanized
2025/10/21New drug · Class 1 TM471-1胶囊 · No verified English nameCXHL2501142 Zhi Wei Pharma Technology (Shanghai) Co., Ltd. romanized
2025/10/20New drug · Class 1 EPI-003注射液 · No verified English nameCXSL2500909 Yi Jie Li Ke (Shanghai) Bio Technology Co., Ltd. romanized
2025/10/18Import · Class 3.1 古塞奇尤单抗注射液 · No verified English nameJXSL2500206 Janssen-Cilag International NV; Johnson & Johnson (China) Investment Ltd.
2025/10/18Import · Class 1 Duvakitug注射液 · No verified English nameJXSL2500205 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2025/10/18Import · Class 1 Duvakitug注射液 · No verified English nameJXSL2500204 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2025/10/18Import · Class 1 Duvakitug注射液 · No verified English nameJXSL2500203 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2025/10/18Generic · Class 3 盐酸昂丹司琼口服溶液 · No verified English nameCYHS2503739 Anhui Xin Shi Ji Pharma Co., Ltd. romanized
2025/10/18Generic · Class 3 盐酸昂丹司琼口服溶液 · No verified English nameCYHS2503738 Anhui Xin Shi Ji Pharma Co., Ltd. romanized
2025/10/18Generic · Class 3 呋喃妥因胶囊 · No verified English nameCYHS2503732 Xizang Zhu Feng Shou Gao Bio Pharma Co., Ltd. romanized; Shandong Yao Shi Pharma Co., Ltd. romanized

124 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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