YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 310 drug applications between 17 March 2026 and 23 March 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 34, covering 29 drug names.
2026/03/17 – 2026/03/23
- New acceptances this week
- 310
- Drugs with new generic filings (by drug name, de-duplicated)
- 29
- Accepted this week, now under review
- 64
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
310filings, 34 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 203 |
| New drug | 45 |
| Generic | 34 |
| Import | 16 |
| Unspecified | 7 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 167 |
| TCM | 113 |
| Therapeutic biologic | 25 |
| 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
29 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Levofloxacin Eye Drops | 3 | 1 | 16 |
| 2 | Isosorbide Mononitrate Extended-Release Tablets | 2 | 1 | 5 |
| 3 | Selexipag Tablets | 2 | 1 | 24 |
| 4 | Lacidipine Tablets | 2 | 1 | 7 |
| 5 | 二硫化硒洗剂 · No verified English name | 1 | 1 | 14 |
| 6 | 伏硫西汀滴剂 · No verified English name | 1 | 1 | 1 |
| 7 | 依非米替片(I) · No verified English name | 1 | 1 | 2 |
| 8 | Lidocaine Cataplasms | 1 | 1 | 7 |
| 9 | 头孢克肟干混悬剂 · No verified English name | 1 | 1 | 3 |
| 10 | Ketotifen Fumarate Oral Solution | 1 | 1 | 8 |
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
178 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized | 9 | 1 | 0 |
| 2 | Jin Zhou Fu Shou Tang Pharmaceuticals Technology Co., Ltd. romanized | 8 | 8 | 0 |
| 3 | Shaanxi Pan Long Pharma Group Co., Ltd. romanized | 8 | 8 | 0 |
| 4 | HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. | 7 | 1 | 0 |
| 5 | Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized | 6 | 5 | 0 |
| 6 | Nei Menggu Ku Lun Meng Yao Co., Ltd. romanized | 5 | 5 | 0 |
| 7 | Qilu Pharmaceutical Co., Ltd. | 5 | 4 | 0 |
| 8 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized | 5 | 3 | 0 |
| 9 | Amgen Inc. | 5 | 2 | 0 |
| 10 | Nanjing Tong Ren Tang Pharma Co., Ltd. romanized | 4 | 4 | 0 |
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
70 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/03/23Import · Class 2.4 | 那米司特片 · No verified English nameJXHL2600090 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2026/03/23Import · Class 2.4 | 那米司特片 · No verified English nameJXHL2600089 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2026/03/23Import · Class 2.4 | 那米司特片 · No verified English nameJXHL2600088 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2026/03/23Generic · Class 3 | 头孢克肟干混悬剂 · No verified English nameCYHS2600697 | Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized; Jin Hong Pharma Co., Ltd. romanized |
| 2026/03/23Generic · Class 3 | 硫酸特布他林口服溶液 · No verified English nameCYHS2600696 | Suzhou Hong Sen Pharma Co., Ltd. romanized; Yang Zhou Shi San Yao Pharmaceutical Co., Ltd. romanized |
| 2026/03/23New drug · Class 2.2 | DMI019鼻喷雾剂 · No verified English nameCXHL2600361 | Jiangsu De Mai Pharma Co., Ltd. romanized |
| 2026/03/23New drug · Class 2.2 | DMI019鼻喷雾剂 · No verified English nameCXHL2600360 | Jiangsu De Mai Pharma Co., Ltd. romanized |
| 2026/03/23New drug · Class 2.2 | DMI019鼻喷雾剂 · No verified English nameCXHL2600359 | Jiangsu De Mai Pharma Co., Ltd. romanized |
| 2026/03/21Import · Class 2.1 | 注射用贝林妥欧单抗(皮下注射) · No verified English nameJXSL2600084 | Amgen Inc.; BeOne Medicines (Beijing) Co. Ltd. |
| 2026/03/21Import · Class 2.1 | 注射用贝林妥欧单抗(皮下注射) · No verified English nameJXSL2600083 | Amgen Inc.; BeOne Medicines (Beijing) Co. Ltd. |
| 2026/03/21Import · Class 1 | MK-1084片 · No verified English nameJXHL2600087 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd |
| 2026/03/21Import · Class 1 | MK-1084片 · No verified English nameJXHL2600086 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd |
| 2026/03/21New drug · Class 2.2 | 夫那奇珠单抗注射液 · No verified English nameCXSL2600342 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2026/03/21New drug · Class 2.2 | 夫那奇珠单抗注射液 · No verified English nameCXSL2600341 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2026/03/21New drug · Class 2.2 | 夫那奇珠单抗注射液 · No verified English nameCXSL2600340 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2026/03/21New drug · Class 1 | SHR-6914注射液 · No verified English nameCXSL2600339 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2026/03/21New drug · Class 1 | HP-002片 · No verified English nameCXHL2600356 | Shanghai Chao Yang Pharma Co., Ltd. romanized |
| 2026/03/21New drug · Class 1 | HP-002片 · No verified English nameCXHL2600355 | Shanghai Chao Yang Pharma Co., Ltd. romanized |
| 2026/03/21New drug · Class 1 | HP-002片 · No verified English nameCXHL2600354 | Shanghai Chao Yang Pharma Co., Ltd. romanized |
| 2026/03/21New drug · Class 1 | HRS9531注射液 · No verified English nameCXHL2600353 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2026/03/21New drug · Class 1 | HRS9531注射液 · No verified English nameCXHL2600352 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2026/03/21New drug · Class 1 | HRS9531注射液 · No verified English nameCXHL2600351 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2026/03/21New drug · Class 1 | HRS9531注射液 · No verified English nameCXHL2600350 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2026/03/21New drug · Class 1 | HRS9531注射液 · No verified English nameCXHL2600349 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2026/03/21New drug · Class 1 | HRS9531注射液 · No verified English nameCXHL2600348 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2026/03/20Import · Class 2.4 | Upadacitinib Sustained-release TabletsJXHS2600032 | AbbVie Deutschland GmbH & Co. KG; AbbVie Ireland NL B.V. |
| 2026/03/20Import · Class 2.4 | Upadacitinib Sustained-release TabletsJXHS2600031 | AbbVie Deutschland GmbH & Co. KG; AbbVie Ireland NL B.V. |
| 2026/03/20Generic · Class 3 | 二硫化硒洗剂 · No verified English nameCYHS2600687 | Shanxi Zhen Dong An Xin Biopharmaceutical Co., Ltd. romanized |
| 2026/03/20New drug · Class 2.1 | YK-2001注射液 · No verified English nameCXHS2600044 | Nanjing Li Bo Wei Pharmaceutical Co., Ltd. romanized; Nanjing You Ke Pharmaceutical Co., Ltd. romanized |
| 2026/03/20New drug · Class 2.1 | YK-2001注射液 · No verified English nameCXHS2600043 | Nanjing Li Bo Wei Pharmaceutical Co., Ltd. romanized; Nanjing You Ke Pharmaceutical Co., Ltd. romanized |
40 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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