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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 315 drug applications between 16 October 2023 and 22 October 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 69, covering 54 drug names.

2023/10/16 – 2023/10/22

Period
2023/10/16 to 2023/10/22, 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
315
Drugs with new generic filings (by drug name, de-duplicated)
54
Accepted this week, now under review
2

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

315filings, 69 of them generic

By application type

Application typeFilings
Supplement170
Generic69
New drug50
Import17
Unspecified5
Import re-registration4

By drug type

Drug typeFilings
Chemical drug212
TCM66
Therapeutic biologic33
Prophylactic biologic4

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

54 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ixazomib Citrate Capsules317
2Lidocaine and Prilocaine Cream2224
3Ambroxol Hydrochloride Solution For Inhalation2110
4Candesartan Cilexetil and Hydrochlorothiazide Tablets210
5复方电解质醋酸钠葡萄糖注射液 · No verified English name2122
6Olanzapine Tablets214
7Tandospirone Citrate Tablets212
8Teneligliptin Hydrobromide Hydrate Tablets2110
9Prucalopride Succinate Tablets211
10Urapidil Hydrochloride Injection216

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

194 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jiangsu Xiu Zheng Pharmaceutical Co., Ltd. romanized16150
2Hainan Pu Li Pharmaceutical Co., Ltd. romanized910
3Shang Qiu Shi Xin Ma Bio Technology Co., Ltd. romanized440
4Guangxi Hong Ji Pharma Group Co., Ltd. romanized440
5Pfizer Europe MA EEIG430
6Ji Li De (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized420
7Xi Nan Pharma Co., Ltd. romanized420
8JANSSEN-CILAG NV410
9TRUEMED LTD.410
10Changchun Jin Sai Pharma Co., Ltd. romanized410

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

94 this week

AcceptedDrugApplicants
2023/10/21Import · Class 2.2 Benralizumab注射液 · No verified English nameJXSL2300188 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2023/10/21Import · Class 1 BI 1015550 片 · No verified English nameJXHL2300264 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2023/10/21Import · Class 1 BI 1015550 片 · No verified English nameJXHL2300263 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2023/10/21Generic · Class 3 Hydrotalcite SuspensionCYHS2302845 Chongqing Zhong Chuang Ke Pharmaceuticals Co., Ltd. romanized; Ya Bao Pharma Guiyang Pharmaceutical Co., Ltd. romanized
2023/10/21Generic · Class 3 Pentoxifylline InjectionCYHS2302843 Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized
2023/10/21Generic · Class 3 Polymyxin B sulfate for InjectionCYHS2302839 Name not romanized; Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized
2023/10/21Generic · Class 3 对乙酰氨基酚颗粒 · No verified English nameCYHS2302836 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2023/10/21Generic · Class 3 Amlodipine Besylate and Benazepril Hydrochloride CapsulesCYHS2302835 Guangdong Yue He Ze Drug Research Co., Ltd. romanized; Jiangsu He Chen Pharma Co., Ltd. romanized
2023/10/21Generic · Class 3 Oseltamivir Phosphate For Oral SuspensionCYHS2302833 Kui Hua Pharma Group (Heng Shui) De Fei Er Co., Ltd. romanized
2023/10/21Generic · Class 3 Oseltamivir Phosphate For Oral SuspensionCYHS2302832 Kui Hua Pharma Group (Heng Shui) De Fei Er Co., Ltd. romanized
2023/10/21Generic · Class 3 聚乙二醇4000散(儿童型) · No verified English nameCYHS2302831 Hubei Lai Kang Medical Technology Co., Ltd. romanized; Guangdong Hua Nan Pharma Group Co., Ltd. romanized
2023/10/21Generic · Class 3 Carbocisteine Oral SolutionCYHS2302828 Guangzhou Shi Lian Rui Pharmaceutical Co., Ltd. romanized; Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized
2023/10/21Generic · Class 3 Dexamethasone Sodium Phosphate InjectionCYHS2302827 Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized
2023/10/21Generic · Class 3 Pregabalin Oral SolutionCYHS2302826 Zhejiang Zhe Bei Pharma Co., Ltd. romanized
2023/10/21New drug · Class 1.1 六金清瘟颗粒 · No verified English nameCXZL2300066 Shandong Hong Ji Tang Pharmaceutical Group Co., Ltd. romanized
2023/10/21New drug · Class 2.3 口服六价重配轮状病毒减毒活疫苗(Vero细胞) · No verified English nameCXSL2300722 Ke Xing (Da Lian) Yi Miao Technology Co., Ltd. romanized; Beijing Ke Xing Zhong Wei Bio Technology Co., Ltd. romanized
2023/10/21New drug · Class 1 BPAb002注射液 · No verified English nameCXSL2300721 Bo Pin Ze Rong (Shenzhen) Biopharmaceuticals Technology Co., Ltd. romanized
2023/10/21New drug · Class 1 重组抗PEAR1单克隆抗体雾化吸入溶液 · No verified English nameCXSL2300720 Shanghai Xun Yao Bio Technology Co., Ltd. romanized
2023/10/21New drug · Class 1 68Ga-NYM005注射液制备用药盒 · No verified English nameCXHL2301147 Wuxi Nuo Yu Pharmaceuticals Technology Co., Ltd. romanized
2023/10/21New drug · Class 1 RLA-23174片 · No verified English nameCXHL2301146 Shanghai Ying Li Pharma Co., Ltd. romanized
2023/10/21New drug · Class 1 RLA-23174片 · No verified English nameCXHL2301145 Shanghai Ying Li Pharma Co., Ltd. romanized
2023/10/21New drug · Class 2.2 CXG86吸入粉雾剂 · No verified English nameCXHL2301144 Hangzhou Xi Xi Pharmaceutical Co., Ltd. romanized
2023/10/21New drug · Class 1 QR056251胶囊 · No verified English nameCXHL2301143 Wuhan Lang Lai Technology Development Co., Ltd. romanized
2023/10/21New drug · Class 1 QR056251胶囊 · No verified English nameCXHL2301142 Wuhan Lang Lai Technology Development Co., Ltd. romanized
2023/10/21New drug · Class 1 ISM5411片 · No verified English nameCXHL2301141 Ying Xi Zhi Neng Technology (Shanghai) Co., Ltd. romanized
2023/10/21New drug · Class 1 ISM5411片 · No verified English nameCXHL2301140 Ying Xi Zhi Neng Technology (Shanghai) Co., Ltd. romanized
2023/10/21New drug · Class 1 BY101921片 · No verified English nameCXHL2301139 Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized
2023/10/21New drug · Class 1 BY101921片 · No verified English nameCXHL2301138 Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized
2023/10/21New drug · Class 1 HRS-3738片 · No verified English nameCXHL2301137 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2023/10/21New drug · Class 1 HRS-3738片 · No verified English nameCXHL2301136 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized

64 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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