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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 473 drug applications between 16 October 2025 and 22 October 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 80, covering 58 drug names.

2025/10/16 – 2025/10/22

Period
2025/10/16 to 2025/10/22, 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
473
Drugs with new generic filings (by drug name, de-duplicated)
58
Accepted this week, now under review
115

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

473filings, 80 of them generic

By application type

Application typeFilings
Supplement285
Generic80
New drug74
Import18
Unspecified11
Import re-registration5

By drug type

Drug typeFilings
Chemical drug306
TCM85
Therapeutic biologic71
Biologic7
Prophylactic biologic3
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

58 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Glucosamine Sulfate Capsules4451
2Vonoprazan Fumarate Tablets4260
3Sacubitril Valsartan Sodium Tablets3270
4Dapagliflozin Tablets3284
5LevomilnacipranHydrochloride Extended-release Capsules316
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注射用托伐普坦磷酸钠 · No verified English name2115

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

258 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jilin Sheng Qi Ke Pharma Co., Ltd. romanized64470
2Boehringer Ingelheim International GmbH1120
3Hunan Nuo Na Pharmaceuticals Technology Co., Ltd. romanized770
4Heilongjiang Jun An Pharma Group Hong Xiang Pharmaceutical Co., Ltd. romanized660
5Xiu Zheng Pharma Group Tian Han Pharma Co., Ltd. romanized550
6Topfond Pharmaceutical Co., Ltd.550
7Tong Hua Si Wei Pharma Co., Ltd. romanized550
8Sichuan Kelun Pharmaceutical Co., Ltd.532
9Sanofi-Aventis Recherche & Développement520
10HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.520

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

121 this week

AcceptedDrugApplicants
2025/10/22Import · Class 3.1 艾普奈珠单抗注射用浓溶液 · No verified English nameJXSS2500134 Lundbeck Seattle BioPharmaceuticals Inc.; Vetter Pharma-Fertigung GmbH & Co.KG; Lundbeck (Beijing) Pharmaceuticals Consulting Co. Ltd.
2025/10/22Generic · Class 3 辅酶Q10片 · No verified English nameCYHS2503760 Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized
2025/10/22Generic · Class 3 Furosemide Oral SolutionCYHS2503758 Jiangsu Ying Ke Biopharmaceutical Co., Ltd. romanized
2025/10/22Generic · Class 3 Labetalol Hydrochloride TabletsCYHS2503757 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2025/10/22Generic · Class 3 Acetylcysteine TabletsCYHS2503754 Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized
2025/10/22New drug · Class 3.1 半夏白术天麻颗粒 · No verified English nameCXZS2500047 Sichuan Guang Da Pharmaceutical Co., Ltd. romanized
2025/10/22New drug · Class 3.1 真武汤颗粒 · No verified English nameCXZS2500046 Hua Run San Jiu (Ya An) Pharma Co., Ltd. romanized
2025/10/22New drug · Class 1.1 舒肝安胃颗粒 · No verified English nameCXZL2500102 Beijing Wei Wei Kang Technology Co., Ltd. romanized
2025/10/22New drug · Class 1 SIM0278注射液 · No verified English nameCXSL2500918 Jiangsu Xian Sheng Pharma Co., Ltd. romanized; Xian Sheng Pharma Co., Ltd. romanized
2025/10/22New drug · Class 3.3 冻干人用狂犬病疫苗(人二倍体细胞) · No verified English nameCXSL2500917 Beijing Bai Hui Bio Technology Co., Ltd. romanized; Bo Hui Biopharmaceutical Co., Ltd. romanized
2025/10/22New drug · Class 1 IMM2510 · No verified English nameCXSL2500916 Yi Ming Ang Ke Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2025/10/22New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2500915 Shenzhen Shi Yin Guan Bio Technology Co., Ltd. romanized
2025/10/22New drug · Class 1 IMM2510 · No verified English nameCXSL2500914 Yi Ming Ang Ke Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2025/10/22New drug · Class 1 NRG-103注射液 · No verified English nameCXSL2500913 Niu Lun Jie Biopharmaceuticals Technology (Suzhou) Co., Ltd. romanized
2025/10/22New drug · Class 1 索特替尼片 · No verified English nameCXHS2500126 Shou Yao Holding (Beijing) Co., Ltd. romanized; Beijing SL Pharmaceutical Co., Ltd.
2025/10/22New drug · Class 1 索特替尼片 · No verified English nameCXHS2500125 Shou Yao Holding (Beijing) Co., Ltd. romanized; Beijing SL Pharmaceutical Co., Ltd.
2025/10/22New drug · Class 2.1; 2.2 CMCY2304口崩片 · No verified English nameCXHL2501156 Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized
2025/10/22New drug · Class 2.1; 2.2 CMCY2304口崩片 · No verified English nameCXHL2501155 Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized
2025/10/22New drug · Class 1 HRS-2141片(II) · No verified English nameCXHL2501154 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/10/22New drug · Class 1 HRS-2141片(I) · No verified English nameCXHL2501153 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/10/22New drug · Class 1 SYH2072片 · No verified English nameCXHL2501152 Shanghai Yi Shi Pharmaceuticals Technology Co., Ltd. romanized
2025/10/22New drug · Class 1 SYH2072片 · No verified English nameCXHL2501151 Shanghai Yi Shi Pharmaceuticals Technology Co., Ltd. romanized
2025/10/22New drug · Class 1 SYH2072片 · No verified English nameCXHL2501150 Shanghai Yi Shi Pharmaceuticals Technology Co., Ltd. romanized
2025/10/22New drug · Class 1 SYH2072片 · No verified English nameCXHL2501149 Shanghai Yi Shi Pharmaceuticals Technology Co., Ltd. romanized
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

91 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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