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
- 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 type | Filings |
|---|---|
| Supplement | 186 |
| Generic | 148 |
| New drug | 81 |
| Import | 26 |
| Unspecified | 12 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 332 |
| TCM | 62 |
| Therapeutic biologic | 58 |
| Biologic | 4 |
| Prophylactic biologic | 1 |
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
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Safinamide Methansulfonate Tablets | 7 | 4 | 20 |
| 2 | Lactulose Oral Solution | 4 | 2 | 34 |
| 3 | Roxadustat Capsules | 4 | 2 | 17 |
| 4 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution | 3 | 3 | 23 |
| 5 | Tadalafil Tablets | 3 | 1 | 23 |
| 6 | Lidocaine and Prilocaine Cream | 3 | 1 | 24 |
| 7 | Sildenafil Citrate Tablets | 3 | 1 | 12 |
| 8 | Alfacalcidol Soft Capsules | 3 | 1 | 9 |
| 9 | Diquafosol Sodium Eye Drops | 2 | 2 | 5 |
| 10 | 维生素B6注射液 · No verified English name | 2 | 2 | 10 |
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
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shandong Qidu Pharmaceutical Co., Ltd. | 10 | 4 | 0 |
| 2 | AstraZeneca AB | 9 | 4 | 0 |
| 3 | Shandong Er Ye Pharmaceutical Co., Ltd. romanized | 6 | 3 | 0 |
| 4 | Bracco Imaging S.P.A. | 6 | 1 | 0 |
| 5 | Kunming Nan Jiang Pharmaceutical Co., Ltd. romanized | 5 | 3 | 1 |
| 6 | ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD. | 5 | 2 | 1 |
| 7 | Heng Chang (Guangzhou) Xin Yao Research Co., Ltd. romanized | 4 | 4 | 0 |
| 8 | Qingdao Guo Xin Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | 4 | 3 | 0 |
| 10 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 4 | 3 | 3 |
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
| Accepted | Drug | Applicants |
|---|---|---|
| 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.
Subscribe to the weekly
No account needed.
The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.