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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 280 drug applications between 5 August 2022 and 11 August 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 56, covering 48 drug names.

2022/08/05 – 2022/08/11

Period
2022/08/05 to 2022/08/11, 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
280
Drugs with new generic filings (by drug name, de-duplicated)
48
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

280filings, 56 of them generic

By application type

Application typeFilings
Supplement164
Generic56
New drug38
Import11
Unspecified5
Import re-registration4
Drug-device combination product2

By drug type

Drug typeFilings
Chemical drug200
TCM53
Therapeutic biologic24
Prophylactic biologic3

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

48 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Salbutamol Sulfate Inhalation Solution312
2Acetylcysteine Granules214
3Ornidazole Injection210
4Empagliflozin Tablets2118
5Temozolomide Capsules210
6Vortioxetine Hydrobromide Tablets2110
7Ambroxol Hydrochloride Oral Solution2146
8丁酸氯维地平乳状注射液 · No verified English name110
9低钙腹膜透析液(乳酸盐-G1.5%) · No verified English name113
10低钙腹膜透析液(乳酸盐-G2.5%) · No verified English name114

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

161 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.41360
2Shanxi Tong Da Pharma Co., Ltd. romanized880
3Guangxi Xiu Zheng Pharmaceutical Co., Ltd. romanized750
4Beijing Yu Sheng Tang Group Shijiazhuang Pharmaceutical Co., Ltd. romanized660
5Shanxi Fen He Pharmaceutical Co., Ltd. romanized550
6Boehringer Ingelheim International GmbH440
7Hebei Wu Luo Pharma Co., Ltd. romanized440
8Hainan Tong Yong Kang Li Pharmaceutical Co., Ltd. romanized410
9Guizhou De Liang Fang Pharma Co., Ltd. romanized330
10Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized323

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

69 this week

AcceptedDrugApplicants
2022/08/11Import · Class 1 XXB750注射液 · No verified English nameJXSL2200132 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2022/08/11Import · Class 1 LOXO-783片 · No verified English nameJXHL2200239 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2022/08/11Import · Class 1 LOXO-783片 · No verified English nameJXHL2200238 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2022/08/11Generic · Class 3 Lamotrigine Extended Release TabletsCYHS2201288 Shanghai Ao Ke Da Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanized
2022/08/11Generic · Class 3 Minoxidil LinimentCYHS2201287 Zhejiang Yuan Li Jian Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2022/08/11Generic · Class 3 Ambroxol Hydrochloride Oral SolutionCYHS2201283 Jiangxi Shimei Pharmaceutical Co., Ltd
2022/08/11Generic · Class 3 Ambroxol Hydrochloride Oral SolutionCYHS2201282 Jiangxi Shimei Pharmaceutical Co., Ltd
2022/08/11Generic · Class 3 Lidocaine Hydrochloride InjectionCYHS2201281 Tong He Biopharmaceuticals (Shandong) Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized
2022/08/11New drug · Class 1 CUD002注射液 · No verified English nameCXSL2200371 Sichuan Kang De Sai Medical Technology Co., Ltd. romanized
2022/08/11New drug · Class 2.2 格隆溴铵吸入喷雾剂 · No verified English nameCXHL2200582 Shanghai Gu Sen Pharmaceuticals Co., Ltd. romanized
2022/08/11New drug · Class 1 CS0159片 · No verified English nameCXHL2200581 Kai Si Kai Di (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized
2022/08/11New drug · Class 1 CS0159片 · No verified English nameCXHL2200580 Kai Si Kai Di (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized
2022/08/11New drug · Class 1 VD1219片 · No verified English nameCXHL2200565 Wei Shen Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2022/08/11New drug · Class 1 VD1219片 · No verified English nameCXHL2200564 Wei Shen Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2022/08/10Import · Class 1 珂罗利单抗注射液 · No verified English nameJXSS2200031 Roche Pharma (Schweiz) AG; Genentech Inc.; Roche (China) Holding Ltd.
2022/08/10Generic · Class 3 Calcium Gluconate InjectionCYHS2201280 Shandong Qidu Pharmaceutical Co., Ltd.
2022/08/10Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2201271 Zhejiang Huan Ling Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanized
2022/08/10New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2200370 Beijing Bei Lai Bio Technology Co., Ltd. romanized
2022/08/10New drug · Class 1 VGR-R01 · No verified English nameCXSL2200369 Shanghai Tian Ze Yun Tai Biopharmaceuticals Co., Ltd. romanized
2022/08/10New drug · Class 1 SYS6002 · No verified English nameCXSL2200368 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2022/08/10New drug · Class 3.3 冻干b型流感嗜血杆菌结合疫苗 · No verified English nameCXSL2200367 Chengdu Ou Lin Bio Technology Co., Ltd. romanized
2022/08/10New drug · Class 2.2 甲磺酸雷沙吉兰舌下膜 · No verified English nameCXHL2200579 Shanghai Shang Yao Zhong Xi Pharmaceutical Co., Ltd. romanized
2022/08/10New drug · Class 1 XNW5004片 · No verified English nameCXHL2200578 Suzhou Xin Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized
2022/08/10New drug · Class 1 XNW5004片 · No verified English nameCXHL2200577 Suzhou Xin Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized
2022/08/10New drug · Class 1 XNW5004片 · No verified English nameCXHL2200576 Suzhou Xin Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized
2022/08/09Generic · Class 3 Isoniazid InjectionCYHS2201267 Shenyang Shuang Ding Pharmaceutical Co., Ltd. romanized
2022/08/09Generic · Class 3 Ibuprofen GranulesCYHS2201266 Rui Yang Pharmaceutical Co., Ltd. romanized
2022/08/09Generic · Class 3 丁酸氯维地平乳状注射液 · No verified English nameCYHS2201262 Nanjing You Ke Pharmaceutical Co., Ltd. romanized
2022/08/09Generic · Class 3 核黄素磷酸钠滴眼液 · No verified English nameCYHS2201261 Ningxia Kang Ya Pharma Co., Ltd. romanized
2022/08/09Generic · Class 3 Esmolol Hydrochloride InjectionCYHS2201260 Beijing Bai Mei Te Biopharmaceutical Co., Ltd. romanized

39 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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