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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 330 drug applications between 7 October 2022 and 13 October 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 74, covering 56 drug names.

2022/10/07 – 2022/10/13

Period
2022/10/07 to 2022/10/13, 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
330
Drugs with new generic filings (by drug name, de-duplicated)
56
Accepted this week, now under review
0

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

330filings, 74 of them generic

By application type

Application typeFilings
Supplement165
Generic74
New drug62
Import re-registration20
Import8
Unspecified1

By drug type

Drug typeFilings
Chemical drug252
Therapeutic biologic37
TCM34
Prophylactic biologic7

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

#DrugNew generic filingsFiling companiesUnder review, all years
1Diquafosol Sodium Eye Drops325
2Compound α-Ketoacid Tablets220
3丁酸氯维地平注射用乳剂 · No verified English name210
4Sodium Valproate Concentrated Solution for Injection210
5复方醋酸钠林格注射液 · No verified English name212
6Montelukast Sodium Chewable Tablets214
7Vonoprazan Fumarate Tablets2160
8Torsemide Injection211
9Telmisartan Tablets214
10Piperacillin Sodium And Tazobactam Sodium For Injection215

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

210 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hainan Pharmaceutical Factory Co., Ltd. Wuhan Branch romanized10100
2Haerbin Jun An Tang Pharmaceuticals Co., Ltd. romanized770
3AstraZeneca UK Limited710
4Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized420
5Jiangsu En Hua Pharma Co., Ltd. romanized420
6Jiangsu Rui Shi Bio Technology Co., Ltd. romanized424
7Hainan Mei Lan Shi Ke Pharmaceutical Co., Ltd. romanized420
8Janssen Research & Development, LLC410
9Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.410
10Guangxi Ling Yun Xian Pharmaceutical 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

102 this week

AcceptedDrugApplicants
2022/10/13Import · Class 2.2 Teclistamab 注射液 · No verified English nameJXSL2200181 Janssen Research & Development, LLC; Johnson & Johnson (China) Investment Ltd.
2022/10/13Import · Class 2.2 Teclistamab 注射液 · No verified English nameJXSL2200180 Janssen Research & Development, LLC; Johnson & Johnson (China) Investment Ltd.
2022/10/13Generic · Class 3 醋酸钠林格葡萄糖注射液 · No verified English nameCYHS2201730 Yang Zi Jiang Pharma Group Shanghai Hai Ni Pharma Co., Ltd. romanized
2022/10/13Generic · Class 3 厄贝沙坦氨氯地平片(Ⅲ) · No verified English nameCYHS2201729 Jiangxi Shimei Pharmaceutical Co., Ltd
2022/10/13Generic · Class 3 厄贝沙坦氨氯地平片(Ⅰ) · No verified English nameCYHS2201728 Jiangxi Shimei Pharmaceutical Co., Ltd
2022/10/13Generic · Class 3 Compound α-Ketoacid TabletsCYHS2201722 Beijing Kang Er Fu Pharma Co., Ltd. romanized
2022/10/13Generic · Class 3 丁酸氯维地平注射用乳剂 · No verified English nameCYHL2200088 CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD.
2022/10/13Generic · Class 3 丁酸氯维地平注射用乳剂 · No verified English nameCYHL2200087 CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD.
2022/10/13Generic · Class 3 ω-3 鱼油中长链脂肪乳/氨基酸(16)/葡萄糖(30%)注射液 · No verified English nameCYHL2200086 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized
2022/10/13New drug · Class 2.2 注射用维迪西妥单抗 · No verified English nameCXSL2200515 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2022/10/13New drug · Class 3.4 人纤维蛋白原 · No verified English nameCXSL2200514 Tong Lu Biopharmaceutical Co., Ltd. romanized
2022/10/13New drug · Class 3.4 人纤维蛋白原 · No verified English nameCXSL2200513 Tong Lu Biopharmaceutical Co., Ltd. romanized
2022/10/13New drug · Class 1 自体抗CLL-1嵌合抗原受体T细胞注射液 · No verified English nameCXSL2200512 Guangzhou Bai Ji Ji Yin Technology Co., Ltd. romanized
2022/10/13New drug · Class 2.2 麻腮风联合减毒活疫苗 · No verified English nameCXSL2200511 Beijing Min Hai Bio Technology Co., Ltd. romanized
2022/10/13New drug · Class 1 NHL35700片 · No verified English nameCXHL2200793 Jiangsu En Hua Pharma Co., Ltd. romanized; Shanghai Shu Jing Bio Technology Co., Ltd. romanized
2022/10/13New drug · Class 1 NHL35700片 · No verified English nameCXHL2200792 Jiangsu En Hua Pharma Co., Ltd. romanized; Shanghai Shu Jing Bio Technology Co., Ltd. romanized
2022/10/13New drug · Class 1 NHL35700片 · No verified English nameCXHL2200791 Jiangsu En Hua Pharma Co., Ltd. romanized; Shanghai Shu Jing Bio Technology Co., Ltd. romanized
2022/10/12Import · Class 1 CB-5339 胶囊 · No verified English nameJXHL2200299 Cleave Therapeutics Inc.; CASI Pharmaceuticals (China) Co. Ltd.
2022/10/12Import · Class 1 CB-5339 胶囊 · No verified English nameJXHL2200298 Cleave Therapeutics Inc.; CASI Pharmaceuticals (China) Co. Ltd.
2022/10/12Generic · Class 3 Esomeprazole Magnesium Enteric-Coated CapsulesCYHS2201719 Zhejiang Er Ying Medicines Co., Ltd. romanized; Zhejiang Jian Feng Pharma Co., Ltd. romanized
2022/10/12Generic · Class 3 Esomeprazole Magnesium Enteric-Coated CapsulesCYHS2201718 Zhejiang Er Ying Medicines Co., Ltd. romanized; Zhejiang Jian Feng Pharma Co., Ltd. romanized
2022/10/12Generic · Class 3 Compound α-Ketoacid TabletsCYHS2201716 Shanghai Zhi Jian Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai Xin Huang He Pharmaceutical Co., Ltd. romanized
2022/10/12Generic · Class 3 ω-3鱼油中长链脂肪乳/氨基酸(16)/葡萄糖(16%)注射液 · No verified English nameCYHS2201713 Sichuan Kelun Pharmaceutical Co., Ltd.
2022/10/12Generic · Class 3 Calcium Acetate Oral SolutionCYHS2201712 Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized
2022/10/12Generic · Class 3 钠钾镁钙葡萄糖注射液 · No verified English nameCYHS2201707 Yi Chang Ren Fu Pharma Co., Ltd. romanized; Yi Chang San Xia Pharmaceutical Co., Ltd. romanized
2022/10/12Generic · Class 3 Betamethasone Sodium Phosphate InjectionCYHS2201703 Chongqing Huapont Pharmaceutical Co., Ltd.
2022/10/12New drug · Class 1.1 小儿二白止痛颗粒 · No verified English nameCXZL2200046 Ying Ke Rui (Tianjin) Innovation Pharmaceuticals Research Co., Ltd. romanized
2022/10/12New drug · Class 3.3 冻干A群C群脑膜炎球菌多糖结合疫苗 · No verified English nameCXSL2200510 Beijing Ke Xing Zhong Wei Bio Technology Co., Ltd. romanized
2022/10/12New drug · Class 1 C66胶囊 · No verified English nameCXHL2200790 Wen Zhou Yi Ke University romanized
2022/10/12New drug · Class 1 HS-10390片 · No verified English nameCXHL2200789 Changzhou Heng Bang Pharma Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized

72 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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