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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 275 drug applications between 23 March 2023 and 29 March 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 65, covering 47 drug names.

2023/03/23 – 2023/03/29

Period
2023/03/23 to 2023/03/29, 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
275
Drugs with new generic filings (by drug name, de-duplicated)
47
Accepted this week, now under review
2

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

275filings, 65 of them generic

By application type

Application typeFilings
Supplement137
Generic65
New drug37
Import21
Unspecified10
Import re-registration5

By drug type

Drug typeFilings
Chemical drug207
Therapeutic biologic32
TCM27
Prophylactic biologic9

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

47 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Polyvinyl Alcohol Eye Drops4324
2Pranoprofen Eye Drops337
3Sildenafil Citrate Tablets3112
4Pamidronate Disodium Injection222
5Moxifloxacin Hydrochloride Eye Drops224
6Linaclotide Capsules2113
7Oxcarbazepine Oral Suspension212
8Torasemide Tablets210
9Sodium Hyaluronate Eye Drops2130
10Ondansetron Hydrochloride Tablets216

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

175 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shanghai Qing Ping Pharma Co., Ltd. romanized980
2Qilu Pharmaceutical (Hainan) Co., Ltd646
3Janssen Research & Development LLC530
4Novartis Europharm Limited530
5Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized530
6Shijiazhuang No.4 Pharmaceutical Co., Ltd.521
7Chengdu Kang Hua Bio Zhi Pin Co., Ltd. romanized420
8Shanghai Chang Zheng Fu Min Jin Shan Pharmaceutical Co., Ltd. romanized333
9Guangxi Shi Biao Pharma Co., Ltd. romanized330
10Jiang You Pharmaceutical (Chang De) 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

80 this week

AcceptedDrugApplicants
2023/03/29Import · Class 2.2 帕博利珠单抗注射液 · No verified English nameJXSS2300028 Merck Sharp & Dohme LLC; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd
2023/03/29Generic · Class 3 Timolol Maleate Eye DropsCYHS2300927 Shenyang Xing Qi Yan Yao Co., Ltd. romanized
2023/03/29Generic · Class 3 Isosorbide Mononitrate Extended-Release TabletsCYHS2300926 Lu Nan Pharmaceutical Group Co., Ltd. romanized; Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized
2023/03/29Generic · Class 3 Zoledronic Acid InjectionCYHS2300923 Sichuan Nuo Fei Te Bio Pharma Technology Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized
2023/03/29New drug · Class 1 BC3402注射液 · No verified English nameCXSL2300222 Wuxi Zhi Kang Hong Yi Bio Technology Co., Ltd. romanized
2023/03/29New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2300221 Hangzhou Yi Wen Sai Bio Technology Co., Ltd. romanized
2023/03/28Import · Class 1.1 重组呼吸道合胞病毒(RSV)疫苗(AS01E 佐剂系统) · No verified English nameJXSL2300062 GlaxoSmithKline Biologicals SA
2023/03/28Import · Class 1 盐酸来罗西利片 · No verified English nameJXHS2300028 G1 Therapeutics Inc.; Quotient Sciences - Philadelphia LLC; Genor Biopharma Co. Ltd
2023/03/28Generic · Class 3 Ondansetron Hydrochloride TabletsCYHS2300910 Hangzhou He Ze Kun Yuan Pharma Co., Ltd. romanized; Ningbo Menovo Tiankang Pharmaceutical Co., Ltd.
2023/03/28Generic · Class 3 Ondansetron Hydrochloride TabletsCYHS2300909 Hangzhou He Ze Kun Yuan Pharma Co., Ltd. romanized; Ningbo Menovo Tiankang Pharmaceutical Co., Ltd.
2023/03/28Generic · Class 3 Oseltamivir Phosphate For Oral SuspensionCYHS2300906 China Resources Sanjiu Medical & Pharmaceutical Co.,Ltd.; Tianjin Han Rui Pharma Co., Ltd. romanized
2023/03/28New drug · Class 1.1 玄黄润通片 · No verified English nameCXZS2300008 Hunan Shi Dai Yang Guang Pharma Co., Ltd. romanized
2023/03/28New drug · Class 1.1 卡比孜胶囊 · No verified English nameCXZL2300023 Xin Qi Kang Pharma Co., Ltd. romanized
2023/03/28New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2300220 Shanghai Lai Fu Medical Technology Co., Ltd. romanized
2023/03/28New drug · Class 3.3 四价流感病毒裂解疫苗 · No verified English nameCXSL2300219 Zhongguo Yi Xue Ke College Yi Xue Bio Xue Research Institute romanized
2023/03/28New drug · Class 3.3 四价流感病毒裂解疫苗 · No verified English nameCXSL2300218 Zhongguo Yi Xue Ke College Yi Xue Bio Xue Research Institute romanized
2023/03/28New drug · Class 1 BAT6026注射液 · No verified English nameCXSL2300217 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2023/03/28New drug · Class 1 IMM-H014片 · No verified English nameCXHL2300339 Zhongguo Yi Xue Ke College Drug Research Institute romanized; Changchun Zuan Zhi Pharmaceutical Co., Ltd. romanized
2023/03/28New drug · Class 1 注射用SZEY-2108 · No verified English nameCXHL2300338 Suzhou Erye Pharmaceutical Co., Ltd
2023/03/28New drug · Class 1 VD1219片 · No verified English nameCXHL2300337 Wei Shen Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2023/03/28New drug · Class 1 VD1219片 · No verified English nameCXHL2300336 Wei Shen Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2023/03/28New drug · Class 1 VD1219片 · No verified English nameCXHL2300335 Wei Shen Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2023/03/28New drug · Class 2.2 罗哌卡因缓释注射液 · No verified English nameCXHL2300334 Jia Li (Shenzhen) Bio Technology Co., Ltd. romanized
2023/03/27Generic · Class 3 Citicoline Sodium InjectionCYHS2300904 Beijing Si Huan Ke Bao Pharma Co., Ltd. romanized; Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2023/03/27Generic · Class 3 Citicoline Sodium InjectionCYHS2300903 Beijing Si Huan Ke Bao Pharma Co., Ltd. romanized; Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2023/03/27New drug · Class 1 APG-2575片 · No verified English nameCXHL2300333 Suzhou Ya Sheng Pharma Co., Ltd. romanized
2023/03/27New drug · Class 1 APG-2575片 · No verified English nameCXHL2300332 Suzhou Ya Sheng Pharma Co., Ltd. romanized
2023/03/27New drug · Class 2.4 奥雷巴替尼片 · No verified English nameCXHL2300331 Guangzhou Shun Jian Biopharmaceuticals Technology Co., Ltd. romanized
2023/03/25Import · Class 2.2 贝利尤单抗注射液(皮下注射) · No verified English nameJXSL2300061 GlaxoSmithKline (Ireland) Limited; GlaxoSmithKline (China) Investment Company Limited
2023/03/25Generic · Class 3 Phenylephrine Hydrochloride InjectionCYHS2300901 Shijiazhuang No.4 Pharmaceutical Co., Ltd.

50 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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