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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 457 drug applications between 20 December 2024 and 26 December 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 148, covering 104 drug names.

2024/12/20 – 2024/12/26

Period
2024/12/20 to 2024/12/26, 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
457
Drugs with new generic filings (by drug name, de-duplicated)
104
Accepted this week, now under review
6

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

457filings, 148 of them generic

By application type

Application typeFilings
Supplement186
Generic148
New drug81
Import26
Unspecified12
Import re-registration4

By drug type

Drug typeFilings
Chemical drug332
TCM62
Therapeutic biologic58
Biologic4
Prophylactic biologic1

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

104 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Safinamide Methansulfonate Tablets7420
2Lactulose Oral Solution4234
3Roxadustat Capsules4217
4Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution3323
5Tadalafil Tablets3123
6Lidocaine and Prilocaine Cream3124
7Sildenafil Citrate Tablets3112
8Alfacalcidol Soft Capsules319
9Diquafosol Sodium Eye Drops225
10维生素B6注射液 · No verified English name2210

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

277 companies with new acceptances; top 10 listed

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

165 this week

AcceptedDrugApplicants
2024/12/26Import · Class 1 AZD2936 · No verified English nameJXSL2400252 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2024/12/26Import · Class 1 AZD8205 · No verified English nameJXSL2400251 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2024/12/26Import · Class 1 AZD5305 · No verified English nameJXHL2400303 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2024/12/26Import · Class 1 AZD5305 · No verified English nameJXHL2400302 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2024/12/26Import · Class 1 AZD5305 · No verified English nameJXHL2400301 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2024/12/26Import · Class 1 AZD5305 · No verified English nameJXHL2400300 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2024/12/26Generic · Class 3 Betamethasone Sodium Phosphate InjectionCYHS2404555 Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized
2024/12/26Generic · Class 3 Diprophylline InjectionCYHS2404553 Jiangxi Ke Wei Pharmaceutical Co., Ltd. romanized; Ya Bang Pharmaceuticals Co., Ltd. romanized
2024/12/26Generic · Class 3 甲氧氯普胺片 · No verified English nameCYHS2404552 Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/12/26Generic · Class 3 甲氧氯普胺片 · No verified English nameCYHS2404551 Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/12/26Generic · Class 3 Fexofenadine Hydrochloride Oral SuspensionCYHS2404550 Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2024/12/26Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2404549 Zhejiang Hua Run San Jiu Zhong Yi Pharmaceutical Co., Ltd. romanized; Tian Da Pharma (Zhuhai) Co., Ltd. romanized
2024/12/26Generic · Class 3 富马酸酮替芬滴眼液 · No verified English nameCYHS2404546 Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/12/26Generic · Class 3 Amisulpride Oral SolutionCYHS2404541 Zhejiang Zhe Bei Pharma Co., Ltd. romanized
2024/12/26Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2404538 Nanchang Li Jian Pharma Co., Ltd. romanized
2024/12/26Generic · Class 3 Sulfamethoxazole and Trimethoprim InjectionCYHS2404534 Suzhou Fu Sheng Pharmaceuticals Technology Co., Ltd. romanized; Shou Guang Fu Kang Pharmaceutical Co., Ltd. romanized
2024/12/26Generic · Class 3 Ibrutinib TabletsCYHS2404530 Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2024/12/26Generic · Class 3 Bromhexine Hydrochloride TabletsCYHS2404529 Bai Yun Shandong Tai Shang Qiu Pharma Co., Ltd. romanized
2024/12/26Generic · Class 3 Eltrombopag Lamine For Oral SuspensionCYHS2404528 Guangzhou Shi Lian Rui Pharmaceutical Co., Ltd. romanized
2024/12/26Generic · Class 3 聚乙二醇4000散(儿童型) · No verified English nameCYHS2404521 Chongqing Sai Nuo Bio Pharma Co., Ltd. romanized
2024/12/26Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2404519 Hunan Jiudian Pharmaceutical Co., Ltd
2024/12/26Generic · Class 3 Esflurbiprofen PatchesCYHL2400275 Shenzhen Fa Ma Yi Medicines Technology Co., Ltd. romanized
2024/12/26Generic · Class 3 贝美前列素涂剂 · No verified English nameCYHL2400274 Shandong Ze Zheng Pharmaceuticals Technology Co., Ltd. romanized
2024/12/26Generic · Class 3 贝美前列素涂剂 · No verified English nameCYHL2400273 Shenzhen Fa Ma Yi Medicines Technology Co., Ltd. romanized
2024/12/26Generic · Class 3 Landiolol Hydrochloride for InjectionCYHL2400272 Zhongshan Wanhan Pharmaceuticals Co., Ltd.
2024/12/26New drug · Class 3.1 开心散 · No verified English nameCXZS2400039 Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanized
2024/12/26New drug · Class 1.1 丹香颗粒 · No verified English nameCXZL2400099 Shenyang Jun Yuan Pharma Co., Ltd. romanized
2024/12/26New drug · Class 1.1 养巢颗粒 · No verified English nameCXZL2400098 Zhang Zhou Pian Zai Huang Pharma Co., Ltd. romanized
2024/12/26New drug · Class 1 HH-003注射液 · No verified English nameCXSS2400142 Hua Hui An Jian (Beijing) Bio Technology Co., Ltd. romanized; Zhi Xiang Bio (Suzhou) Co., Ltd. romanized
2024/12/26New drug · Class 1 依苏帕格鲁肽α注射液 · No verified English nameCXSL2400908 Shanghai Yin Nuo Biopharmaceuticals Gong Cheng Co., Ltd. romanized

135 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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