YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 305 drug applications between 15 September 2022 and 21 September 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 65, covering 47 drug names.

2022/09/15 – 2022/09/21

Period
2022/09/15 to 2022/09/21, 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
305
Drugs with new generic filings (by drug name, de-duplicated)
47
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

305filings, 65 of them generic

By application type

Application typeFilings
Supplement159
Generic65
New drug53
Import14
Unspecified9
Import re-registration5

By drug type

Drug typeFilings
Chemical drug227
TCM42
Therapeutic biologic32
Biologic3
In vitro diagnostic reagent1

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
1Dapagliflozin And Metformin Hydrochloride Extended-Release Tablets510
2Indobufen Tablets326
3Oseltamivir Phosphate For Oral Suspension322
4Oseltamivir Phosphate Capsules3139
5Nintedanib Esilate Soft Capsules216
6Tandospirone Citrate Tablets212
7Tranexamic Acid Injection2111
8Teicoplanin for Injection216
9Hydrocortisone Sodium Succinate for Injection2116
10Doxorubicin Hydrochloride Liposome Injection212

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

173 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shanghai Yan An Pharma Co., Ltd. romanized12110
2Guangxi Jin Xing Industrial Co., Ltd. romanized1060
3Da Jia Wei Kang Biopharmaceutical Co., Ltd. romanized860
4Da Lian Tian Shan Pharma Co., Ltd. romanized660
5Actelion Pharmaceuticals Ltd620
6Jiangxi Ke Rui Pharma Co., Ltd. romanized550
7Boehringer Ingelheim International GmbH510
8Sanofi -aventis France510
9Shanghai Xuan Tai Pharmaceuticals Technology Co., Ltd. romanized515
10Shanghai Huang Xiang Tie Li Lan Tian Pharmaceutical Co., Ltd. romanized440

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

98 this week

AcceptedDrugApplicants
2022/09/21Import · Class 2.2 注射用Tafasitamab · No verified English nameJXSL2200168 Incyte Biosciences Distribution B.V.; Beijing InnoCare Pharma Tech Co. Ltd.
2022/09/21Import · Class 1 LEO 152020 薄膜包衣片 · No verified English nameJXHL2200289 LEO Pharma A/S; LEO Pharma Consultany(Shanghai) company Limited
2022/09/21Import · Class 1 注射用TNP-2092 · No verified English nameJXHL2200288 TenNor Therapeutics Inc.; TenNor (Suzhou) Therapeutics Limited
2022/09/21Generic · Class 3 Neostigmine Methylsulfate InjectionCYHS2201577 Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2022/09/21Generic · Class 3 Cilostazol TabletsCYHS2201576 Beijing Foyou Pharma CO.,LTD
2022/09/21Generic · Class 3 Indobufen TabletsCYHS2201574 Zhejiang Mei Di Shen Biopharmaceuticals Co., Ltd. romanized; Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized
2022/09/21New drug · Class 1.2 枳实总黄酮苷提取物 · No verified English nameCXZS2200009 Jiangxi Qing Feng Pharma Co., Ltd. romanized
2022/09/21New drug · Class 1.2 奥兰替胃康片 · No verified English nameCXZS2200008 Jiangxi Qing Feng Pharma Co., Ltd. romanized
2022/09/21New drug · Class 1 注射用 TQB2102 · No verified English nameCXSL2200472 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2022/09/21New drug · Class 3.4 人凝血酶 · No verified English nameCXSL2200471 Sichuan Yuan Da Shu Yang Pharma Co., Ltd. romanized
2022/09/21New drug · Class 3.4 人凝血酶 · No verified English nameCXSL2200470 Sichuan Yuan Da Shu Yang Pharma Co., Ltd. romanized
2022/09/21New drug · Class 3.4 人凝血酶 · No verified English nameCXSL2200469 Sichuan Yuan Da Shu Yang Pharma Co., Ltd. romanized
2022/09/21New drug · Class 1 注射用HBT-708 · No verified English nameCXSL2200468 Dan Sheng Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2022/09/21New drug · Class 1 TQB2450注射液 · No verified English nameCXSL2200467 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2022/09/20Import · Class 2.4 度维利塞胶囊 · No verified English nameJXHL2200287 Secura Bio Inc.; CSPC ZHONGQI PHARMACEUTICAL TECHNOLOGY (SJZ) CO. LTD.
2022/09/20Import · Class 2.4 度维利塞胶囊 · No verified English nameJXHL2200286 Secura Bio Inc.; CSPC ZHONGQI PHARMACEUTICAL TECHNOLOGY (SJZ) CO. LTD.
2022/09/20Generic · Class 3 多潘立酮干混悬剂 · No verified English nameCYHS2201569 Zhejiang Ya Tai Pharma Co., Ltd. romanized
2022/09/20Generic · Class 3 Minoxidil LinimentCYHS2201568 Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2022/09/20Generic · Class 3 Peramivir InjectionCYHS2201567 Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized
2022/09/20Generic · Class 3 Cytarabine InjectionCYHS2201565 Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized
2022/09/20Generic · Class 3 Cytarabine InjectionCYHS2201564 Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized
2022/09/20New drug · Class 1 注射用XNW4107 · No verified English nameCXHL2200710 Suzhou Xin Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized
2022/09/20New drug · Class 1 伯瑞替尼肠溶胶囊 · No verified English nameCXHL2200709 Beijing Pu Run Ao Bio Technology Co., Ltd. romanized
2022/09/20New drug · Class 1 伯瑞替尼肠溶胶囊 · No verified English nameCXHL2200708 Beijing Pu Run Ao Bio Technology Co., Ltd. romanized
2022/09/20New drug · Class 1 PLB1004胶囊 · No verified English nameCXHL2200707 Beijing An Shi Bio Technology Co., Ltd. romanized
2022/09/20New drug · Class 1 PLB1004胶囊 · No verified English nameCXHL2200706 Beijing An Shi Bio Technology Co., Ltd. romanized
2022/09/19Import · Class 1 OMTX705注射用浓溶液 · No verified English nameJXSL2200167 InxMed (Hong Kong) Limited; InxMed (Nanjing) Co. Ltd
2022/09/19Generic · Class 3 Digoxin InjectionCYHS2201563 Hebei Kun An Pharma Co., Ltd. romanized; Hebei Kai Wei Pharmaceutical Co., Ltd. romanized
2022/09/19Generic · Class 3 Doxorubicin Hydrochloride Liposome InjectionCYHS2201562 Changzhou Wu He Biopharmaceuticals Co., Ltd. romanized; Wuxi Zi Shan Pharma Co., Ltd. romanized
2022/09/19Generic · Class 3 Doxorubicin Hydrochloride Liposome InjectionCYHS2201561 Changzhou Wu He Biopharmaceuticals Co., Ltd. romanized; Wuxi Zi Shan Pharma Co., Ltd. romanized

68 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.