YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 288 drug applications between 1 September 2022 and 7 September 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 49, covering 38 drug names.

2022/09/01 – 2022/09/07

Period
2022/09/01 to 2022/09/07, 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
288
Drugs with new generic filings (by drug name, de-duplicated)
38
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

288filings, 49 of them generic

By application type

Application typeFilings
Supplement156
Generic49
New drug34
Import22
Unspecified19
Import re-registration8

By drug type

Drug typeFilings
Chemical drug201
TCM54
Therapeutic biologic31
Biologic1
Prophylactic 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

38 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Lidocaine Hydrochloride Injection316
2Sitagliptin Phosphate Tablets312
3Diquafosol Sodium Eye Drops225
4Ipratropium Bromide Inhalation Solution212
5Ozagrel Sodium Injection213
6Ornidazole Injection210
7Parecoxib Sodium for Injection212
8Palonosetron Hydrochloride Injection211
9Dapagliflozin Tablets2184
10Piracetam Injection119

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

147 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Da Jia Wei Kang Biopharmaceutical Co., Ltd. romanized31290
2Bayer AG11110
3Jin Zhou Fu Shou Tang Pharmaceuticals Technology Co., Ltd. romanized870
4Guo Yao Group Gong Ye Co., Ltd. romanized770
5Eli Lilly and Company720
6Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized610
7Guangxi Sheng Min Pharmaceutical Co., Ltd. romanized550
8AstraZeneca AB530
9Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized530
10Ferring GmbH440

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

67 this week

AcceptedDrugApplicants
2022/09/07Generic · Class 3 Pentoxifylline InjectionCYHS2201467 Shandong Tai He Pharmaceuticals Technology Co., Ltd. romanized; Jewim Pharmaceutical (Shandong) Co., Ltd.
2022/09/07Generic · Class 3 腺苷钴胺胶囊 · No verified English nameCYHS2201465 Hainan Sai Li Ke Pharma Co., Ltd. romanized
2022/09/07New drug · Class 1 自体RAK细胞注射液 · No verified English nameCXSL2200446 Pu Hua Sai Er Bio Medical Technology Co., Ltd. romanized
2022/09/07New drug · Class 1 自体RAK细胞注射液 · No verified English nameCXSL2200445 Pu Hua Sai Er Bio Medical Technology Co., Ltd. romanized; Zhongguo Yi Xue Ke College Zhong Liu Hospital romanized
2022/09/07New drug · Class 1 聚乙二醇重组人促红素注射液 · No verified English nameCXSL2200444 Shenzhen Sai Bao Er Bio Pharma Co., Ltd. romanized
2022/09/07New drug · Class 2.2 兰索拉唑碳酸氢钠胶囊 · No verified English nameCXHS2200046 Xiamen En Cheng Pharmaceutical Co., Ltd. romanized
2022/09/06Import · Class 1 AZD7789 · No verified English nameJXSL2200155 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2022/09/06Import · Class 2.4 Inclisiran注射液 · No verified English nameJXHL2200278 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd
2022/09/06Import · Class 2.4 Inclisiran注射液 · No verified English nameJXHL2200277 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd
2022/09/06Import · Class 1 MK-0616胶囊 · No verified English nameJXHL2200276 Merck Sharp & Dohme LLC; Name not romanized
2022/09/06Import · Class 1 MK-0616胶囊 · No verified English nameJXHL2200275 Merck Sharp & Dohme LLC; Name not romanized
2022/09/06Generic · Class 3 Levofloxacin InjectionCYHS2201462 Anhui Pioneer Pharmaceutical Co., Ltd
2022/09/06Generic · Class 3 Lidocaine Hydrochloride InjectionCYHS2201460 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2022/09/06Generic · Class 3 Lidocaine Hydrochloride InjectionCYHS2201459 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2022/09/06Generic · Class 3 Lidocaine Hydrochloride InjectionCYHS2201458 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2022/09/06Generic · Class 3 Technetium [99mTc] Tetrofosmin InjectionCYHS2201457 Nanjing Jiang Yuan An Di Ke Zheng Dian Zi Research Development Co., Ltd. romanized
2022/09/06New drug · Class 1 QX004N注射液 · No verified English nameCXSL2200443 Jiangsu Quan Xin Biopharmaceuticals Co., Ltd. romanized
2022/09/06New drug · Class 1 HMI-115 · No verified English nameCXSL2200442 He Qi Rui Pharmaceuticals (Nanjing) Co., Ltd. romanized
2022/09/06New drug · Class 1 注射用TQB2934 · No verified English nameCXSL2200441 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2022/09/06New drug · Class 1 KQ-L6自体嵌合抗原受体T细胞注射液 · No verified English nameCXSL2200440 Shanghai Ke Qi Pharma Technology Co., Ltd. romanized
2022/09/06New drug · Class 1 QL1706注射液 · No verified English nameCXSL2200439 Qilu Pharmaceutical Co., Ltd.
2022/09/06New drug · Class 1 DC561043片 · No verified English nameCXHL2200656 Zhongguo Ke College Shanghai Drug Research Institute romanized
2022/09/06New drug · Class 1 DC561043片 · No verified English nameCXHL2200655 Zhongguo Ke College Shanghai Drug Research Institute romanized
2022/09/06New drug · Class 1 DC561043片 · No verified English nameCXHL2200654 Zhongguo Ke College Shanghai Drug Research Institute romanized
2022/09/06New drug · Class 1 FZJ-003凝胶 · No verified English nameCXHL2200653 Shanghai Fu Dan Zhang Jiang Biopharmaceuticals Co., Ltd. romanized
2022/09/06New drug · Class 1 FZJ-003凝胶 · No verified English nameCXHL2200652 Shanghai Fu Dan Zhang Jiang Biopharmaceuticals Co., Ltd. romanized
2022/09/06New drug · Class 1 BEBT-607片 · No verified English nameCXHL2200651 Guangzhou Bi Bei Te Pharmaceuticals Co., Ltd. romanized
2022/09/06New drug · Class 1 BEBT-607片 · No verified English nameCXHL2200650 Guangzhou Bi Bei Te Pharmaceuticals Co., Ltd. romanized
2022/09/05New drug · Class 1 LM-101注射液 · No verified English nameCXSL2200438 Li Xin Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2022/09/05New drug · Class 1 KP104注射液 · No verified English nameCXSL2200437 Ke Yue Pharmaceuticals (Suzhou) Co., Ltd. romanized

37 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.

Subscribe to the weekly

No account needed.

The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.

A text version of this report, weekly, in the language you subscribe in. You will receive one confirmation email first; sending starts only after you click its link. Every issue carries an unsubscribe link.