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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 319 drug applications between 11 January 2024 and 17 January 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 105, covering 78 drug names.

2024/01/11 – 2024/01/17

Period
2024/01/11 to 2024/01/17, 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
319
Drugs with new generic filings (by drug name, de-duplicated)
78
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

319filings, 105 of them generic

By application type

Application typeFilings
Supplement136
Generic105
New drug53
Import14
Import re-registration7
Unspecified4

By drug type

Drug typeFilings
Chemical drug224
TCM48
Therapeutic biologic42
Prophylactic biologic3
Biologic2

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 name624
2Diquafosol Sodium Eye Drops335
3Potassium Chloride Oral Solution3311
4Levofloxacin Injection321
5Pregabalin Extended release Tablets3113
6Acetylcysteine Injection2253
7Diprophylline Injection227
8Morinidazole and Sodium Chloride Injection229
9Glucosamine Sulfate Capsules2251
10Tadalafil Tablets2123

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

198 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Zhengzhou Rui Long Pharmaceutical Co., Ltd. romanized650
2ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.632
3Sanofi-Aventis Recherche & Developpement610
4Xiamen Te Bao Bio Gong Cheng Co., Ltd. romanized510
5Guangdong Ke Lun Pharma Co., Ltd. romanized510
6Jiangxi Nanchang Ji Sheng Pharmaceutical Co., Ltd. romanized440
7Beng Bu Feng Yuan Tu Shan Pharmaceutical Co., Ltd. romanized440
8Pfizer Inc.420
9CSPC OUYI PHARMACEUTICAL CO., LTD.423
10YaoPharma Co., Ltd.424

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

105 this week

AcceptedDrugApplicants
2024/01/17Import · Class 2.2 索米妥昔单抗注射液 · No verified English nameJXSL2400019 ImmunoGen Inc.; HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO. LTD.
2024/01/17Generic · Class 3 Acetylcysteine InjectionCYHS2400245 Sichuan Shang Shan Liu Jing Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized
2024/01/17Generic · Class 3 山梨醇甘露醇冲洗剂 · No verified English nameCYHS2400243 Shandong Wei Gao Pharma Co., Ltd. romanized
2024/01/17Generic · Class 3 Famotidine InjectionCYHS2400237 Sichuan Qi Yu Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized
2024/01/17New drug · Class 2.2 贝伐珠单抗注射液 · No verified English nameCXSS2400010 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized
2024/01/17New drug · Class 1 菲诺利单抗注射液 · No verified English nameCXSS2400009 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized
2024/01/17New drug · Class 1 SHR-2173注射液 · No verified English nameCXSL2400034 Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/01/17New drug · Class 1 BM230冻干制剂 · No verified English nameCXSL2400033 Suzhou Bo Ao Ming Sai Biopharmaceutical Co., Ltd. romanized; Shanghai Bo Ao Ming Sai Bio Technology Co., Ltd. romanized
2024/01/17New drug · Class 1 重组人神经生长因子滴眼液 · No verified English nameCXSL2400032 Jiangsu Zhong Xin Pharmaceuticals Co., Ltd. romanized
2024/01/17New drug · Class 2.2 BCM858口溶膜 · No verified English nameCXHL2400078 Shanghai Yun Cheng Yan Xin Bio Technology Co., Ltd. romanized
2024/01/17New drug · Class 2.2 BCM858口溶膜 · No verified English nameCXHL2400077 Shanghai Yun Cheng Yan Xin Bio Technology Co., Ltd. romanized
2024/01/17New drug · Class 2.2 BCM858口溶膜 · No verified English nameCXHL2400076 Shanghai Yun Cheng Yan Xin Bio Technology Co., Ltd. romanized
2024/01/17New drug · Class 1 HSK31858片 · No verified English nameCXHL2400075 Xizang Hai Si Ke Pharmaceutical Co., Ltd. romanized
2024/01/16Generic · Class 3 Nicorandil for InjectionCYHS2400232 Lang Tian Pharma (Hubei) Co., Ltd. romanized
2024/01/16Generic · Class 3 Drotaverine Hydrochloride TabletsCYHS2400228 Jiangxi Yi You Pharma Co., Ltd. romanized
2024/01/16Generic · Class 3 Furosemide Oral SolutionCYHS2400219 Jian Min Pharma Group Co., Ltd. romanized
2024/01/16New drug · Class 1.1 痔瘘熏洗颗粒 · No verified English nameCXZL2400004 Su Zhong Pharma Group Co., Ltd. romanized; Jiangsu Su Zhong Pharma Research Institute Co., Ltd. romanized
2024/01/16New drug · Class 1 注射用YL201 · No verified English nameCXSL2400031 Suzhou Yi Lian Biopharmaceuticals Co., Ltd. romanized
2024/01/16New drug · Class 1 注射用SHR-7631 · No verified English nameCXSL2400030 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2024/01/16New drug · Class 1 HP501缓释片 · No verified English nameCXHL2400074 Hai Chuang Pharma Co., Ltd. romanized
2024/01/16New drug · Class 1 HP501缓释片 · No verified English nameCXHL2400073 Hai Chuang Pharma Co., Ltd. romanized
2024/01/16New drug · Class 2.1; 2.2 注射用QP-6211 · No verified English nameCXHL2400072 Nanjing Qing Pu Bio Technology Co., Ltd. romanized
2024/01/15Generic · Class 3 Oxycodone Hydrochloride TabletsCYHS2400213 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2024/01/15Generic · Class 3 Oxycodone Hydrochloride TabletsCYHS2400212 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2024/01/15Generic · Class 3 Oxacillin Sodium for InjectionCYHS2400211 Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Shandong Er Ye Pharmaceutical Co., Ltd. romanized
2024/01/15Generic · Class 3 Oxacillin Sodium for InjectionCYHS2400210 Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Shandong Er Ye Pharmaceutical Co., Ltd. romanized
2024/01/15Generic · Class 3 硝苯地平缓释片(II) · No verified English nameCYHS2400208 ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.
2024/01/15New drug · Class 2.4 Abiraterone Acetate TabletsCXHL2400071 Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized
2024/01/13Generic · Class 3 腺苷钴胺胶囊 · No verified English nameCYHS2400206 Hainan Zi Cheng Zhong Tou Bio Technology Co., Ltd. romanized; Tianjin Shi Zhong Yang Pharma Co., Ltd. romanized
2024/01/13Generic · Class 3 苯磺酸氨氯地平口崩片 · No verified English nameCYHS2400205 Guangdong Wan Tai Ke Chuang Pharma Co., Ltd. romanized; Shenzhen Xin Li Tai Pharma Co., Ltd. romanized

75 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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