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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 224 drug applications between 7 September 2022 and 13 September 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 50, covering 35 drug names.

2022/09/07 – 2022/09/13

Period
2022/09/07 to 2022/09/13, 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
224
Drugs with new generic filings (by drug name, de-duplicated)
35
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

224filings, 50 of them generic

By application type

Application typeFilings
Supplement112
Generic50
New drug28
Import23
Import re-registration7
Unspecified4

By drug type

Drug typeFilings
Chemical drug161
Therapeutic biologic37
TCM22
Prophylactic biologic3
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

35 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Carfilzomib For Injection310
2Cefotiam Hydrochloride For Injection310
3Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution2223
4Rivaroxaban Fine Granules210
5Ipratropium Bromide Inhalation Solution212
6Olaparib Tablets210
7Peramivir Injection217
8Tranexamic Acid Injection2111
9Parecoxib Sodium for Injection212
10Vardenafil Hydrochloride Tablets214

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

135 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Da Jia Wei Kang Biopharmaceutical Co., Ltd. romanized990
2Eli Lilly and Company620
3Baxalta US Inc.610
4Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized610
5Janssen-Cilag International NV540
6Boehringer Ingelheim International GmbH510
7Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized410
8Haerbin Yuan Hua Pharma Co., Ltd. romanized330
9Ha Yao Group San Jing Er Tong Da Pharmaceutical Factory (Co., Ltd.) romanized330
10Gui Lin Nan Yao Co., Ltd. romanized332

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

68 this week

AcceptedDrugApplicants
2022/09/13Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2201510 Jiangxi Shimei Pharmaceutical Co., Ltd
2022/09/13Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2201509 Sichuan Yi Sheng Zhi Tong Pharmaceuticals Bio Technology Development Co., Ltd. romanized; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized
2022/09/13Generic · Class 3 Hydrotalcite SuspensionCYHS2201508 Hangzhou Min Sheng Health Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2022/09/13New drug · Class 1 SYH2045片 · No verified English nameCXHL2200672 Shanghai Yi Shi Pharmaceuticals Technology Co., Ltd. romanized
2022/09/13New drug · Class 1 SYH2045片 · No verified English nameCXHL2200671 Shanghai Yi Shi Pharmaceuticals Technology Co., Ltd. romanized
2022/09/10Import · Class 1 利特昔替尼胶囊 · No verified English nameJXHS2200081 Pfizer Inc.; Pfizer Manufacturing Deutschland GmbH; Pfizer Investment Co. Ltd.
2022/09/10Import · Class 2.4 Dapagliflozin TabletsJXHS2200080 AstraZeneca AB; AstraZeneca Pharmaceuticals LP; AstraZeneca Investment (China)Co. Ltd.
2022/09/10Import · Class 2.4 Dapagliflozin TabletsJXHS2200079 AstraZeneca AB; AstraZeneca Pharmaceuticals LP; AstraZeneca Investment (China)Co. Ltd.
2022/09/10Import · Class 1 KIN-3248片 · No verified English nameJXHL2200284 Kinnjiu Biopharma Limited; PPC China Corporation Limited
2022/09/10Import · Class 1 KIN-3248片 · No verified English nameJXHL2200283 Kinnjiu Biopharma Limited; PPC China Corporation Limited
2022/09/10Import · Class 1 KIN-3248片 · No verified English nameJXHL2200282 Kinnjiu Biopharma Limited; PPC China Corporation Limited
2022/09/10Generic · Class 3 Aripiprazole Oral SolutionCYHS2201507 Jin Zhou Ao Hong Pharma Co., Ltd. romanized
2022/09/10Generic · Class 3 Aripiprazole Oral SolutionCYHS2201506 Jin Zhou Ao Hong Pharma Co., Ltd. romanized
2022/09/10Generic · Class 3 Cefotiam Hydrochloride For InjectionCYHS2201505 Qi Lu An Ti Pharmaceutical Co., Ltd. romanized
2022/09/10Generic · Class 3 Cefotiam Hydrochloride For InjectionCYHS2201504 Qi Lu An Ti Pharmaceutical Co., Ltd. romanized
2022/09/10Generic · Class 3 Cefotiam Hydrochloride For InjectionCYHS2201503 Qi Lu An Ti Pharmaceutical Co., Ltd. romanized
2022/09/10Generic · Class 3 Peramivir InjectionCYHS2201501 Hebei Tian Cheng Pharma Co., Ltd. romanized
2022/09/10Generic · Class 3 Peramivir InjectionCYHS2201500 Hebei Tian Cheng Pharma Co., Ltd. romanized
2022/09/10New drug · Class 1 Y101D · No verified English nameCXSL2200456 Wuhan You Zhi You Biopharmaceutical Co., Ltd. romanized
2022/09/10New drug · Class 1 注射用YL202 · No verified English nameCXSL2200455 Suzhou Yi Lian Biopharmaceuticals Co., Ltd. romanized
2022/09/10New drug · Class 2.2 BH009注射液 · No verified English nameCXHL2200668 Zhuhai Bei Hai Bio Technology Co., Ltd. romanized
2022/09/10New drug · Class 1 注射用 GMDTC · No verified English nameCXHL2200667 Jian Er Sheng (Zhuhai) Pharmaceuticals Technology Co., Ltd. romanized
2022/09/10New drug · Class 1 卟硒啉片 · No verified English nameCXHL2200666 Shanghai Yuan Xi Pharmaceuticals Technology Co., Ltd. romanized
2022/09/10New drug · Class 1 卟硒啉片 · No verified English nameCXHL2200665 Shanghai Yuan Xi Pharmaceuticals Technology Co., Ltd. romanized
2022/09/10New drug · Class 1 卟硒啉片 · No verified English nameCXHL2200664 Shanghai Yuan Xi Pharmaceuticals Technology Co., Ltd. romanized
2022/09/09Import · Class 3.1 安纳白介素注射液(预充式) · No verified English nameJXSS2200034 Swedish Orphan Biovitrum AB (publ); Hospira Zagreb d.o.o.; SOBI Pharma (Shanghai) Company Limited
2022/09/09Import · Class 3.1 古塞奇尤单抗注射液 · No verified English nameJXSL2200163 Janssen-Cilag International NV; Xian Janssen Pharmaceutical Ltd.
2022/09/09Import · Class 3.1 注射用培重组人凝血因子Ⅷ · No verified English nameJXSL2200162 Baxalta US Inc.; Takeda(China) International Trading Co. Ltd
2022/09/09Import · Class 3.1 注射用培重组人凝血因子Ⅷ · No verified English nameJXSL2200161 Baxalta US Inc.; Takeda(China) International Trading Co. Ltd
2022/09/09Import · Class 3.1 注射用培重组人凝血因子Ⅷ · No verified English nameJXSL2200160 Baxalta US Inc.; Takeda(China) International Trading Co. Ltd

38 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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