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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 304 drug applications between 12 November 2022 and 18 November 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 62, covering 46 drug names.

2022/11/12 – 2022/11/18

Period
2022/11/12 to 2022/11/18, 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
304
Drugs with new generic filings (by drug name, de-duplicated)
46
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

304filings, 62 of them generic

By application type

Application typeFilings
Supplement176
Generic62
New drug35
Import15
Unspecified9
Import re-registration7

By drug type

Drug typeFilings
Chemical drug223
TCM43
Therapeutic biologic38

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

46 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Palbociclib Capsules310
2Pregabalin Capsules3112
3Lidocaine Hydrochloride Injection316
4Sitagliptin Phosphate Tablets312
5Tadalafil Tablets2123
6Lamotrigine Tablets210
7Sildenafil Citrate Tablets2112
8Esomeprazole Sodium for Injection211
9Procaterol Hydrochloride Oral Solution2112
10羟乙基淀粉130/0.4电解质注射液 · No verified English name212

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
1Henan Shuang He Hua Li Pharma Co., Ltd. romanized1230
2Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized990
3Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized720
4GE Healthcare AS710
5Boehringer Ingelheim International GmbH610
6Hua Run San Jiu (Chen Zhou) Pharmaceutical Co., Ltd. romanized550
7Hefei Hua Fang Pharmaceuticals Technology Co., Ltd. romanized550
8UCB Pharma SA520
9Xian Sheng Pharma Co., Ltd. romanized523
10Haerbin Han Bang Medical Technology Co., Ltd. romanized510

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

62 this week

AcceptedDrugApplicants
2022/11/18Generic · Class 3 Naloxone Hydrochloride InjectionCYHS2202015 Chongqing Lai Mei Pharma Co., Ltd. romanized
2022/11/18Generic · Class 3 头孢克肟颗粒 · No verified English nameCYHS2201935 Hefei En Rui Te Pharma Co., Ltd. romanized; Anhui An Ke Heng Yi Pharma Co., Ltd. romanized
2022/11/18New drug · Class 3.4 人凝血酶原复合物 · No verified English nameCXSS2200091 Shenzhen Shi Wei Guang Bio Zhi Pin Co., Ltd. romanized
2022/11/18New drug · Class 1 注射用IMM0306 · No verified English nameCXSL2200583 Yi Ming Ang Ke Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2022/11/18New drug · Class 1 注射用PRO1184 · No verified English nameCXSL2200582 Pu Fang Biopharmaceutical (Suzhou) Co., Ltd. romanized
2022/11/18New drug · Class 1 ELPIS人脐带间充质干细胞注射液 · No verified English nameCXSL2200581 Hua Xia Yuan (Shanghai) Bio Technology Co., Ltd. romanized
2022/11/17Generic · Class 3 Digoxin InjectionCYHS2202003 Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2022/11/17Generic · Class 3 Formoterol Fumarate Inhalation SolutionCYHS2202000 Shanghai Ao Ke Da Pharmaceuticals Technology Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2022/11/17New drug · Class 1.1 金连消风颗粒 · No verified English nameCXZL2200052 Ying Ke Rui (Tianjin) Innovation Pharmaceuticals Research Co., Ltd. romanized
2022/11/17New drug · Class 1 注射用BB-1709 · No verified English nameCXSL2200580 Bai Li Si Kang Biopharmaceuticals (Hangzhou) Co., Ltd. romanized
2022/11/17New drug · Class 2.2 普特利单抗注射液 · No verified English nameCXSL2200578 Le Pu Bio Technology Co., Ltd. romanized
2022/11/17New drug · Class 1 GC012F注射液 · No verified English nameCXSL2200577 Suzhou Gen Xi Bio Technology Co., Ltd. romanized; Gen Xi Bio Technology (Shanghai) Co., Ltd. romanized
2022/11/17New drug · Class 2.2 马来酸噻吗洛尔乳膏 · No verified English nameCXHL2200905 Shanghai Fu Dan Zhang Jiang Biopharmaceuticals Co., Ltd. romanized
2022/11/17New drug · Class 1 BEBT-503胶囊 · No verified English nameCXHL2200904 Guangzhou Bi Bei Te Pharmaceuticals Co., Ltd. romanized
2022/11/17New drug · Class 1 BEBT-503胶囊 · No verified English nameCXHL2200903 Guangzhou Bi Bei Te Pharmaceuticals Co., Ltd. romanized
2022/11/17New drug · Class 1 WS012干混悬剂 · No verified English nameCXHL2200902 Zhong Mei Hua Shi Tong Biopharmaceuticals Technology (Wuhan) Co., Ltd. romanized
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.

32 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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