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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 295 drug applications between 10 November 2022 and 16 November 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 73, covering 53 drug names.

2022/11/10 – 2022/11/16

Period
2022/11/10 to 2022/11/16, 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
295
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

295filings, 73 of them generic

By application type

Application typeFilings
Supplement162
Generic73
New drug31
Import15
Unspecified9
Import re-registration5

By drug type

Drug typeFilings
Chemical drug215
TCM49
Therapeutic biologic30
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

53 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Palbociclib Capsules310
2Pregabalin Capsules3112
3Tranexamic Acid Injection3111
4Lidocaine Hydrochloride Injection316
5Fesoterodine Fumarate Prolonged-Release Tablets210
6Hydrocodone Bitartrate and Ibuprofen Tablets210
7Tandospirone Citrate Tablets212
8Sildenafil Citrate Tablets2112
9Nicorandil for Injection211
10Esomeprazole Sodium for Injection211

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

170 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Nei Menggu Meng He Pharmaceutical Co., Ltd. romanized13130
2Henan Shuang He Hua Li Pharma Co., Ltd. romanized1230
3Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized990
4Boehringer Ingelheim International GmbH610
5Hua Run San Jiu (Chen Zhou) Pharmaceutical Co., Ltd. romanized550
6UCB Pharma SA520
7Xian Sheng Pharma Co., Ltd. romanized523
8Haerbin Han Bang Medical Technology Co., Ltd. romanized510
9Yan Tai Dong Cheng Da Yang Pharmaceutical Co., Ltd. romanized440
10Chengdu Brilliant Pharmaceutical Co., Ltd.421

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
2022/11/16Import · Class 3.1 司库奇尤单抗注射液 · No verified English nameJXSS2200036 Novartis Pharma Schweiz AG; Novartis Pharma Stein AG; Beijing Novartis Pharma Co. Ltd.
2022/11/16Import · Class 3.1 司库奇尤单抗注射液 · No verified English nameJXSS2200035 Novartis Pharma Schweiz AG; Novartis Pharma Stein AG; Beijing Novartis Pharma Co. Ltd.
2022/11/16Import · Class 1 CG0070注射液 · No verified English nameJXSL2200201 CG Oncology Inc.; Lepu Biopharma Co. Ltd.
2022/11/16Import · Class 1 ARV-471(PF-07850327 )片 · No verified English nameJXHL2200338 Pfizer Inc; Pfizer Investment CO. Ltd.
2022/11/16Generic · Class 3 Procaterol Hydrochloride Oral SolutionCYHS2201995 Chengdu Shuo De Pharma Co., Ltd. romanized
2022/11/16Generic · Class 3 Procaterol Hydrochloride Oral SolutionCYHS2201994 Chengdu Shuo De Pharma Co., Ltd. romanized
2022/11/16Generic · Class 3 水溶性黄体酮注射液 · No verified English nameCYHL2200104 Changchun Jin Sai Pharma Co., Ltd. romanized
2022/11/16New drug · Class 1.1 芍药舒筋片 · No verified English nameCXZS2200015 Jiangsu Wan Bang Sheng Hua Pharmaceuticals Group Co., Ltd. romanized; Hebei Wan Bang Fu Lin Pharma Co., Ltd. romanized
2022/11/16New drug · Class 1.1 双根口服液 · No verified English nameCXZL2200051 Zhongguo Ren Min Jie Fang Jun Zong Hospital Di Wu Yi Xue Center romanized
2022/11/16New drug · Class 1 重组抗PD-1全人源单克隆抗体注射液 · No verified English nameCXSL2200576 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2022/11/16New drug · Class 1 PD-1基因定制活化T细胞注射液 · No verified English nameCXSL2200575 Anhui Ke Dun Bio Technology Co., Ltd. romanized
2022/11/16New drug · Class 1 HV-101注射液 · No verified English nameCXSL2200574 Hangzhou Hou Wu Biopharmaceuticals Technology Co., Ltd. romanized; Guangdong Tian Ke Ya Biopharmaceuticals Technology Co., Ltd. romanized
2022/11/16New drug · Class 2.4 注射用多西他赛(白蛋白结合型) · No verified English nameCXHL2200901 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2022/11/15Import · Class 1 PF-06821497片 · No verified English nameJXHL2200336 Pfizer Inc.; Pfizer Investment CO. Ltd.
2022/11/15Import · Class 1 PF-06821497片 · No verified English nameJXHL2200335 Pfizer Inc.; Pfizer Investment CO. Ltd.
2022/11/15Generic · Class 3 Bromhexine Hydrochloride InjectionCYHS2201992 Tianjin Jin Yao Group Hubei Tian Yao Pharma Co., Ltd. romanized; Hubei Jin Yao Pharma Co., Ltd. romanized
2022/11/15Generic · Class 3 Famciclovir TabletsCYHS2201981 Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.
2022/11/15Generic · Class 3 6-[18F]Fluoro-L-DOPA InjectionCYHL2200103 Jiangsu Hua Yi Technology Co., Ltd. romanized
2022/11/15New drug · Class 1.1 藿夏感冒颗粒 · No verified English nameCXZL2200050 Shijiazhuang Yi Ling Pharma Co., Ltd. romanized
2022/11/15New drug · Class 2.2 注射用重组人TNK组织型纤溶酶原激活剂 · No verified English nameCXSS2200090 Shi Yao Group Ming Fu Le Pharma (Guangzhou) Co., Ltd. romanized
2022/11/15New drug · Class 1 BR108注射液 · No verified English nameCXSL2200573 Hai Zheng Biopharmaceutical Co., Ltd. romanized; Zhejiang Bo Rui Biopharmaceutical Co., Ltd. romanized
2022/11/15New drug · Class 2.2 右布洛芬缓控释双层片 · No verified English nameCXHL2200900 Yue Yang Pharmaceuticals Kai Fa (Guangzhou) Co., Ltd. romanized
2022/11/15New drug · Class 1 注射用顺眠肽 · No verified English nameCXHL2200899 Guangzhou Liu Shun Bio Technology Co., Ltd. romanized
2022/11/15New drug · Class 1 ZN-A-1041肠溶胶囊 · No verified English nameCXHL2200898 Suzhou Zan Rong Pharmaceuticals Technology Co., Ltd. romanized
2022/11/15New drug · Class 1 甲磺酸贝福替尼胶囊 · No verified English nameCXHL2200897 Bei Da Pharma Co., Ltd. romanized
2022/11/15New drug · Class 1 甲磺酸贝福替尼胶囊 · No verified English nameCXHL2200896 Bei Da Pharma Co., Ltd. romanized
2022/11/15New drug · Class 1 SIM0270胶囊 · No verified English nameCXHL2200895 Xian Sheng Pharma Co., Ltd. romanized
2022/11/14Generic · Class 3 Lidocaine Hydrochloride InjectionCYHS2201979 Beijing Shi Qiao Biopharmaceutical Co., Ltd. romanized
2022/11/14Generic · Class 3 Lidocaine Hydrochloride InjectionCYHS2201978 Beijing Shi Qiao Biopharmaceutical Co., Ltd. romanized
2022/11/14Generic · Class 3 Lidocaine Hydrochloride InjectionCYHS2201977 Beijing Shi Qiao Biopharmaceutical 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.

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