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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 420 drug applications between 17 May 2023 and 23 May 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 71, covering 46 drug names.

2023/05/17 – 2023/05/23

Period
2023/05/17 to 2023/05/23, 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
420
Drugs with new generic filings (by drug name, de-duplicated)
46
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

420filings, 71 of them generic

By application type

Application typeFilings
Supplement254
Generic71
New drug63
Import14
Import re-registration11
Unspecified7

By drug type

Drug typeFilings
Chemical drug286
TCM89
Therapeutic biologic40
Biologic3
Prophylactic biologic2

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

46 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Roxadustat Capsules8417
2Metformin Hydrochloride And Empagliflozin Extended Release Tablets4112
3Ropivacaine hydrochloride injection415
4Nicorandil for Injection321
5Indobufen Tablets226
6地氯雷他定口服溶液 · No verified English name2226
7氧(液态) · No verified English name2213
8腺苷钴胺胶囊 · No verified English name228
9盐酸左沙丁胺醇雾化吸入溶液 · No verified English name212
10Isoprenaline Hydrochloride Injection217

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

187 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Chongqing Di Kang Zhong Yao Pharmaceutical Co., Ltd. romanized61590
2Hubei Lang De Pharma Co., Ltd. romanized34160
3Zhong Jia Bio Technology (Hubei Sheng) Co., Ltd. romanized28130
4Ping Guang Pharmaceutical Co., Ltd. romanized14140
5UCB Pharma SA610
6Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized520
7Shijiazhuang No.4 Pharmaceutical Co., Ltd.433
8Liaoning Min Kang Pharmaceutical Co., Ltd. romanized420
9Shanghai Hui Lun Jiangsu Pharma Co., Ltd. romanized414
10Beijing Pu Qi Pharmaceuticals Technology Co., Ltd. romanized410

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

109 this week

AcceptedDrugApplicants
2023/05/23Generic · Class 3 Nicorandil for InjectionCYHS2301394 Chongqing Lai Mei Pharma Co., Ltd. romanized
2023/05/23Generic · Class 3 Nicorandil for InjectionCYHS2301393 Chongqing Lai Mei Pharma Co., Ltd. romanized
2023/05/23Generic · Class 3 Rivastigmine Hydrogen Tartrate Oral SolutionCYHS2301390 Bai Shan Technology (Hu Zhou) Co., Ltd. romanized; Zhejiang Kai Run Pharma Co., Ltd. romanized
2023/05/23Generic · Class 3 Methocarbamol InjectionCYHS2301383 Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized
2023/05/23Generic · Class 3 Minoxidil Topical SolutionCYHS2301380 Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/05/23Generic · Class 3 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2301378 Shanxi Yang He Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Guo Run Pharmaceutical Co., Ltd. romanized
2023/05/23Generic · Class 3 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2301377 Shanxi Yang He Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Guo Run Pharmaceutical Co., Ltd. romanized
2023/05/23Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2301371 Nanjing Chuang Di Bio Technology Co., Ltd. romanized; Jiangsu Bei Jia Pharmaceutical Co., Ltd. romanized
2023/05/23Generic · Class 3 Acetylcysteine Oral SolutionCYHS2301370 Anhui Mao Kang Pharma Co., Ltd. romanized; Hua Yi Pharma Technology (Anhui) Co., Ltd. romanized
2023/05/23New drug · Class 2.2 特瑞普利单抗注射液 · No verified English nameCXSS2300037 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai Jun Shi Bio Gong Cheng Co., Ltd. romanized; Suzhou Zhong He Biopharmaceuticals Technology Co., Ltd. romanized
2023/05/23New drug · Class 2.2 特瑞普利单抗注射液 · No verified English nameCXSS2300036 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai Jun Shi Bio Gong Cheng Co., Ltd. romanized; Suzhou Zhong He Biopharmaceuticals Technology Co., Ltd. romanized
2023/05/23New drug · Class 1 HD CD19 CAR-T细胞 · No verified English nameCXSL2300368 Hua Dao (Shanghai) Biopharmaceuticals Co., Ltd. romanized
2023/05/23New drug · Class 1 注射用ZG006 · No verified English nameCXSL2300367 Name not romanized
2023/05/23New drug · Class 1 注射用BRY812 · No verified English nameCXSL2300366 Zhejiang Bo Rui Biopharmaceutical Co., Ltd. romanized; Hai Zheng Biopharmaceutical Co., Ltd. romanized
2023/05/23New drug · Class 1 MI078胶囊 · No verified English nameCXHL2300565 Mai Nuo Wei (Wuxi) Pharmaceuticals Technology Co., Ltd. romanized; Nanjing Mai Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized
2023/05/23New drug · Class 1 MI078胶囊 · No verified English nameCXHL2300564 Mai Nuo Wei (Wuxi) Pharmaceuticals Technology Co., Ltd. romanized; Nanjing Mai Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized
2023/05/23New drug · Class 1 MI078胶囊 · No verified English nameCXHL2300563 Mai Nuo Wei (Wuxi) Pharmaceuticals Technology Co., Ltd. romanized; Nanjing Mai Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized
2023/05/23New drug · Class 1 PG-011 鼻喷雾剂 · No verified English nameCXHL2300561 Beijing Pu Qi Pharmaceuticals Technology Co., Ltd. romanized
2023/05/23New drug · Class 1 PG-011 鼻喷雾剂 · No verified English nameCXHL2300560 Beijing Pu Qi Pharmaceuticals Technology Co., Ltd. romanized
2023/05/23New drug · Class 1 PG-011 鼻喷雾剂 · No verified English nameCXHL2300559 Beijing Pu Qi Pharmaceuticals Technology Co., Ltd. romanized
2023/05/23New drug · Class 1 PG-011 鼻喷雾剂 · No verified English nameCXHL2300558 Beijing Pu Qi Pharmaceuticals Technology Co., Ltd. romanized
2023/05/23New drug · Class 1 ONC201胶囊 · No verified English nameCXHL2300557 China Resources Sanjiu Medical & Pharmaceutical Co.,Ltd.
2023/05/23New drug · Class 2.2 泼尼松无水吞服颗粒 · No verified English nameCXHL2300556 Beijing Ke Xin Ju Run Pharmaceuticals Technology Co., Ltd. romanized
2023/05/22Import · Class 1 SAR442501 · No verified English nameJXSL2300097 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2023/05/22Generic · Class 3 Lincomycin InjectionCYHS2301368 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2023/05/22Generic · Class 3 Biapenem For InjectionCYHS2301365 Anhui Pioneer Pharmaceutical Co., Ltd
2023/05/22Generic · Class 3 Methotrexate TabletsCYHS2301363 Guo Yao Yi Xin Pharmaceutical Co., Ltd. romanized
2023/05/22Generic · Class 3 Pentazocine InjectionCYHS2301361 SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED
2023/05/22New drug · Class 1 注射用XNW28012 · No verified English nameCXSL2300365 Shanghai Xin Nuo Wei Biopharmaceuticals Co., Ltd. romanized
2023/05/22New drug · Class 1 SM17单克隆抗体注射液 · No verified English nameCXSL2300364 Xing Lian Pharma (Suzhou) Co., Ltd. romanized

79 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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