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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 287 drug applications between 1 June 2023 and 7 June 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 78, covering 53 drug names.

2023/06/01 – 2023/06/07

Period
2023/06/01 to 2023/06/07, 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
287
Drugs with new generic filings (by drug name, de-duplicated)
53
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

287filings, 78 of them generic

By application type

Application typeFilings
Supplement126
Generic78
New drug51
Import21
Import re-registration7
Unspecified4

By drug type

Drug typeFilings
Chemical drug208
Therapeutic biologic45
TCM33
Biologic1

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

53 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Oxacillin Sodium for Injection4213
2Lactulose Oral Solution3334
3Minoxidil Topical Solution320
4Neostigmine Methylsulfate Injection314
5Nitroglycerin Sublingual Tablets313
6预充式甲氨蝶呤注射液 · No verified English name310
7Glucosamine Sulfate Capsules2251
8Hydrotalcite Chewable Tablets226
9Procaterol Hydrochloride Solution for Inhalation212
10Sildenafil Citrate Tablets2112

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

166 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Ping Guang Pharmaceutical Co., Ltd. romanized10100
2AbbVie Inc.740
3Dong Guan Shi Yang Zhi Kang Pharmaceuticals Co., Ltd. romanized650
4Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized610
5CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD520
6Novo Nordisk A/S510
7Hangzhou Gao Guang Pharmaceutical Co., Ltd. romanized510
8Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized420
9YaoPharma Co., Ltd.421
10Kang Rong Dong Fang (Guangdong) Pharmaceuticals 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

95 this week

AcceptedDrugApplicants
2023/06/07Import · Class 2.2 注射用戈沙妥珠单抗 · No verified English nameJXSL2300105 Gilead Sciences Inc.; Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd.
2023/06/07Import · Class 1 注射用sotatercept · No verified English nameJXSL2300104 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd.
2023/06/07Import · Class 1 注射用sotatercept · No verified English nameJXSL2300103 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd.
2023/06/07Import · Class 1 Astegolimab注射液 · No verified English nameJXSL2300102 F. Hoffmann-La Roche Ltd; Roche(China) Holding Ltd.
2023/06/07Import · Class 1 TAK-676注射液 · No verified English nameJXHL2300137 Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd
2023/06/07Generic · Class 3 Procaterol Hydrochloride Solution for InhalationCYHS2301558 Shenzhen Shi Bei Mei Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/06/07Generic · Class 3 Procaterol Hydrochloride Solution for InhalationCYHS2301557 Shenzhen Shi Bei Mei Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/06/07Generic · Class 3 Diprophylline InjectionCYHS2301556 Sen Miao (Shandong) Pharma Co., Ltd. romanized; Hubei Jin Yao Pharma Co., Ltd. romanized
2023/06/07Generic · Class 3 Magnesium Sulfate InjectionCYHS2301554 Jin Ling Pharma Co., Ltd. Nanjing Jin Ling Pharmaceutical Factory romanized
2023/06/07Generic · Class 3 Methocarbamol InjectionCYHS2301553 Jiangxi Qing Feng Pharma Co., Ltd. romanized
2023/06/07Generic · Class 3 Minoxidil Topical SolutionCYHS2301548 China Resources Sanjiu Medical & Pharmaceutical Co.,Ltd.; Zhongshan Wanhan Pharmaceuticals Co., Ltd.
2023/06/07Generic · Class 3 Potassium Chloride InjectionCYHS2301547 Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized
2023/06/07Generic · Class 3 Neostigmine Methylsulfate InjectionCYHS2301545 Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized
2023/06/07Generic · Class 3 Neostigmine Methylsulfate InjectionCYHS2301544 Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized
2023/06/07Generic · Class 3 Neostigmine Methylsulfate InjectionCYHS2301543 Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized
2023/06/07Generic · Class 3 Minoxidil Topical SolutionCYHS2301537 Mei Luo Pharma Co., Ltd. romanized
2023/06/07Generic · Class 3 Minoxidil Topical SolutionCYHS2301536 Mei Luo Pharma Co., Ltd. romanized
2023/06/07Generic · Class 3 Oxacillin Sodium for InjectionCYHS2301534 Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Zhong Fu Pharma Co., Ltd. romanized
2023/06/07Generic · Class 3 Oxacillin Sodium for InjectionCYHS2301533 Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Zhong Fu Pharma Co., Ltd. romanized
2023/06/07New drug · Class 1.1 乌鳖还闺颗粒 · No verified English nameCXZL2300039 Jiangsu Kang Yuan Pharma Co., Ltd. romanized
2023/06/07New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSL2300398 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2023/06/07New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSL2300397 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2023/06/07New drug · Class 1 KYS202002A注射液 · No verified English nameCXSL2300396 Jiangsu Kang Yuan Pharma Co., Ltd. romanized
2023/06/07New drug · Class 2.4 ZHB107-108舌下片 · No verified English nameCXSL2300395 Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized
2023/06/07New drug · Class 2.4 ZHB107-108舌下片 · No verified English nameCXSL2300394 Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized
2023/06/07New drug · Class 2.4 ZHB107-108舌下片 · No verified English nameCXSL2300393 Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized
2023/06/07New drug · Class 2.4 ZHB107-108舌下片 · No verified English nameCXSL2300392 Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized
2023/06/07New drug · Class 2.4 ZHB107-108舌下片 · No verified English nameCXSL2300391 Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized
2023/06/07New drug · Class 2.4 ZHB107-108舌下片 · No verified English nameCXSL2300390 Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized
2023/06/07New drug · Class 1 [18F]BF3-BPA注射液 · No verified English nameCXHL2300616 Suzhou Bo Rui Chuang He Pharmaceuticals Co., Ltd. romanized

65 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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