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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 281 drug applications between 12 January 2024 and 18 January 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 93, covering 69 drug names.

2024/01/12 – 2024/01/18

Period
2024/01/12 to 2024/01/18, 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
281
Drugs with new generic filings (by drug name, de-duplicated)
69
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

281filings, 93 of them generic

By application type

Application typeFilings
Supplement125
Generic93
New drug42
Import9
Import re-registration7
Unspecified5

By drug type

Drug typeFilings
Chemical drug188
TCM47
Therapeutic biologic39
Biologic4
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

69 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
2Pregabalin Extended release Tablets3113
3Morinidazole and Sodium Chloride Injection229
4Diquafosol Sodium Eye Drops225
5Procaterol Hydrochloride Oral Solution2212
6腺苷钴胺胶囊 · No verified English name228
7Tadalafil Tablets2123
8Crizotinib Capsules217
9Piracetam Injection219
10Olmesartan Medoxomil and Amlodipine Besylate Tablets212

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

175 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
4Guangdong Ke Lun Pharma Co., Ltd. romanized510
5Jiangxi Nanchang Ji Sheng Pharmaceutical Co., Ltd. romanized440
6Henan Sheng Bai Quan Pharmaceutical Co., Ltd. romanized440
7Gansu Yong He Tang Pharma Co., Ltd. romanized440
8Novo Nordisk A/S420
9CSPC OUYI PHARMACEUTICAL CO., LTD.423
10Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized414

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

90 this week

AcceptedDrugApplicants
2024/01/18Generic · Class 3 Mometasone Furoate CreamCYHS2400262 Chongqing Huapont Pharmaceutical Co., Ltd.
2024/01/18Generic · Class 3 Piracetam InjectionCYHS2400261 Hunan Sai Long Pharma (Changsha) Co., Ltd. romanized
2024/01/18Generic · Class 3 Piracetam InjectionCYHS2400260 Hunan Sai Long Pharma (Changsha) Co., Ltd. romanized
2024/01/18Generic · Class 3 Procaterol Hydrochloride Oral SolutionCYHS2400259 Jiangsu Guang Cheng Pharma Co., Ltd. romanized
2024/01/18Generic · Class 3 Compound Paracetamol and Vitamin C Effervescent TabletsCYHS2400256 Jiangxi Ren Qi Pharmaceutical Co., Ltd. romanized
2024/01/18Generic · Class 3 Nimodipine Oral SolutionCYHS2400255 Changzhou Si Yao Pharmaceutical Co., Ltd. romanized
2024/01/18Generic · Class 3 腺苷钴胺胶囊 · No verified English nameCYHS2400254 Zhejiang Mei Di Shen Biopharmaceuticals Co., Ltd. romanized; Yi Ling Wan Zhou International Pharmaceutical Co., Ltd. romanized
2024/01/18Generic · Class 3 Bromhexine Hydrochloride Oral SolutionCYHS2400253 Fu Yuan Pharma Co., Ltd. romanized
2024/01/18Generic · Class 3 Bromhexine Hydrochloride Oral SolutionCYHS2400252 Fu Yuan Pharma Co., Ltd. romanized
2024/01/18Generic · Class 3 复方聚乙二醇(3350)电解质散 · No verified English nameCYHS2400249 Ling Yao Bio Technology (Shanghai) Co., Ltd. romanized; Nanjing Hou Sheng Pharma Co., Ltd. romanized
2024/01/18Generic · Class 3 米诺地尔泡沫剂 · No verified English nameCYHL2400021 Guangdong Hong Shan Hu Pharma Co., Ltd. romanized
2024/01/18New drug · Class 2.1; 2.2 注射用维迪西妥单抗 · No verified English nameCXSL2400037 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2024/01/18New drug · Class 1 HS-20117注射液 · No verified English nameCXSL2400036 Changzhou Heng Bang Pharma Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2024/01/18New drug · Class 1 DM919注射液 · No verified English nameCXSL2400035 Dan Ma (Suzhou) Biopharmaceuticals Technology Co., Ltd. romanized
2024/01/18New drug · Class 2.2 帕拉米韦吸入溶液 · No verified English nameCXHL2400082 Lang Tian Pharmaceuticals Technology (Wuhan) Co., Ltd. romanized
2024/01/18New drug · Class 2.2 帕拉米韦吸入溶液 · No verified English nameCXHL2400081 Lang Tian Pharmaceuticals Technology (Wuhan) Co., Ltd. romanized
2024/01/18New drug · Class 1 锝[99mTc]肼基烟酰胺双链Ark肽注射液 · No verified English nameCXHL2400080 Guangdong Rui Di Ao Technology Co., Ltd. romanized
2024/01/18New drug · Class 2.2 左乙拉西坦缓释颗粒 · No verified English nameCXHL2400079 Hangzhou Bai Cheng Pharmaceuticals Technology Co., Ltd. romanized
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

60 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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