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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 359 drug applications between 23 December 2023 and 29 December 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 109, covering 78 drug names.

2023/12/23 – 2023/12/29

Period
2023/12/23 to 2023/12/29, 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
359
Drugs with new generic filings (by drug name, de-duplicated)
78
Accepted this week, now under review
1

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

359filings, 109 of them generic

By application type

Application typeFilings
Supplement154
Generic109
New drug63
Import15
Import re-registration12
Unspecified6

By drug type

Drug typeFilings
Chemical drug269
TCM47
Therapeutic biologic37
Prophylactic biologic6

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

78 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1注射用头孢唑肟钠 · No verified English name424
2Azilsartan Medoxomil Potassium Tablets4235
3Penicillin G Sodium For Injection412
4Potassium Chloride Injection3210
5Sitagliptin and Metformin Hydrochloride Extended-release Tablets3212
6Sodium Valproate Sustained-release Tablets(I)224
7Lidocaine and Prilocaine Cream2224
8Telmisartan And Amlodipine Tablets2210
9氧 · No verified English name2215
10Nicorandil for Injection221

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

212 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Bo Rui Xin Chuang Biopharmaceuticals Technology (Wuxi) Co., Ltd. romanized1410
2Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized767
3Shenyang Hong Yao Group Co., Ltd. romanized760
4Guangzhou Bai Yun Shan Tian Xin Pharmaceutical Co., Ltd. romanized740
5Boehringer Ingelheim International GmbH720
6Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized520
7Chengdu Bei Te Biopharmaceutical Co., Ltd. romanized510
8Ha Yao Group San Jing Qian He Pharmaceutical Co., Ltd. romanized440
9Chongqing Di Kang Zhong Yao Pharmaceutical Co., Ltd. romanized440
10Beijing Bu Lin Bio Technology Co., Ltd. romanized434

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

129 this week

AcceptedDrugApplicants
2023/12/29Generic · Class 3 Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric Acid Oral SolutionCYHS2303677 Beijing Min Kang Bai Cao Pharmaceuticals Technology Co., Ltd. romanized; Tian Da Pharma (Zhuhai) Co., Ltd. romanized
2023/12/29Generic · Class 3 Metaraminol Tartrate InjectionCYHS2303676 Wuhan Jiu An Pharma Co., Ltd. romanized; Lang Tian Pharma (Hubei) Co., Ltd. romanized
2023/12/29Generic · Class 3 Sodium Bicarbonate InjectionCYHS2303675 Beijing Min Kang Bai Cao Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized
2023/12/29Generic · Class 3 Nicorandil for InjectionCYHS2303672 Hebei Long Hai Pharma Co., Ltd. romanized; Hebei Yi Pin Pharmaceutical Co., Ltd. romanized
2023/12/29Generic · Class 3 Azithromycin Eye DropsCYHL2300168 Nanjing Heng Dao Pharmaceuticals Technology Co., Ltd. romanized
2023/12/29Generic · Class 3 利多卡因丙胺卡因气雾剂 · No verified English nameCYHL2300167 Jiangsu Ke Fei Ping Pharmaceuticals Co., Ltd. romanized
2023/12/29New drug · Class 1 BD001细胞注射液 · No verified English nameCXSL2300908 Shenzhen Bin De Bio Technology Co., Ltd. romanized
2023/12/29New drug · Class 1 注射用BAT8008 · No verified English nameCXSL2300907 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2023/12/29New drug · Class 1 BAT1308注射液 · No verified English nameCXSL2300906 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2023/12/29New drug · Class 1 NGGT002注射液 · No verified English nameCXSL2300905 Suzhou Nuo Jie Bei Bio Technology Co., Ltd. romanized
2023/12/29New drug · Class 1 格舒瑞昔片 · No verified English nameCXHS2300122 Yi Fang Bio Technology (Shanghai) Co., Ltd. romanized; Wuxi He Quan Pharma Co., Ltd. romanized
2023/12/29New drug · Class 1 富马酸泰吉利定注射液 · No verified English nameCXHS2300121 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2023/12/29New drug · Class 1 富马酸泰吉利定注射液 · No verified English nameCXHS2300120 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2023/12/29New drug · Class 1 BR005-036C片 · No verified English nameCXHL2301469 Xi Yuan An Jian Pharmaceuticals (Beijing) Co., Ltd. romanized
2023/12/29New drug · Class 1 BR005-036C片 · No verified English nameCXHL2301468 Xi Yuan An Jian Pharmaceuticals (Beijing) Co., Ltd. romanized
2023/12/29New drug · Class 1 GW201口崩片 · No verified English nameCXHL2301467 Beijing Guang Wei Pharmaceuticals Technology Co., Ltd. romanized
2023/12/29New drug · Class 1 GW201口崩片 · No verified English nameCXHL2301466 Beijing Guang Wei Pharmaceuticals Technology Co., Ltd. romanized
2023/12/29New drug · Class 1 注射用NC527-X · No verified English nameCXHL2301465 Zhejiang Hai Bai Bio Technology Co., Ltd. romanized
2023/12/28Import · Class 2.2 Cemiplimab · No verified English nameJXSL2300237 Regeneron Ireland Designated Activity Company (DAC); Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd
2023/12/28Import · Class 3.4 注射用CU-20101 · No verified English nameJXSL2300236 CKD BiO Corporation
2023/12/28Import · Class 1 M1774胶囊 · No verified English nameJXHL2300330 Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd
2023/12/28Import · Class 1 M1774胶囊 · No verified English nameJXHL2300329 Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd
2023/12/28Generic · Class 3 吲哚美辛凝胶贴膏 · No verified English nameCYHS2303665 Hunan Jiudian Pharmaceutical Co., Ltd
2023/12/28Generic · Class 3 Methocarbamol InjectionCYHS2303661 Beijing Wo Bang Pharmaceuticals Technology Co., Ltd. romanized; Yin Gu Pharmaceutical Co., Ltd. romanized
2023/12/28Generic · Class 3 Loxoprofen Sodium Oral SolutionCYHS2303660 Chongqing Huapont Pharmaceutical Co., Ltd.
2023/12/28Generic · Class 3 Penicillin G Sodium For InjectionCYHS2303653 Kunming Nan Jiang Pharmaceutical Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2023/12/28Generic · Class 3 Penicillin G Sodium For InjectionCYHS2303652 Kunming Nan Jiang Pharmaceutical Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2023/12/28Generic · Class 3 Penicillin G Sodium For InjectionCYHS2303651 Kunming Nan Jiang Pharmaceutical Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2023/12/28Generic · Class 3 Penicillin G Sodium For InjectionCYHS2303650 Kunming Nan Jiang Pharmaceutical Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2023/12/28Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2303649 Jiangsu Dong Ke Kang De Pharma Co., Ltd. romanized; Jiangsu Ou Ge Pharmaceutical Co., Ltd. romanized

99 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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