YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 292 drug applications between 13 March 2026 and 19 March 2026 (data as of 14 November 2026 06:00). Of these, generic applications numbered 40, covering 31 drug names.
2026/03/13 – 2026/03/19
- New acceptances this week
- 292
- Drugs with new generic filings (by drug name, de-duplicated)
- 31
- Accepted this week, now under review
- 66
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
292filings, 40 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 162 |
| New drug | 61 |
| Generic | 40 |
| Import | 13 |
| Unspecified | 12 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 160 |
| TCM | 82 |
| Therapeutic biologic | 42 |
| Biologic | 7 |
| 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
31 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 | 达普司他片 · No verified English name | 3 | 1 | 0 |
| 3 | Crizotinib Capsules | 2 | 1 | 7 |
| 4 | Isosorbide Mononitrate Extended-Release Tablets | 2 | 1 | 5 |
| 5 | Lacidipine Tablets | 2 | 1 | 7 |
| 6 | 注射用阿立哌唑 · No verified English name | 2 | 1 | 4 |
| 7 | Mirogabalin Besilate Tablets | 2 | 1 | 61 |
| 8 | 伏硫西汀滴剂 · No verified English name | 1 | 1 | 1 |
| 9 | Lidocaine Cataplasms | 1 | 1 | 8 |
| 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
173 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jin Zhou Fu Shou Tang Pharmaceuticals Technology Co., Ltd. romanized | 8 | 8 | 0 |
| 2 | Qilu Pharmaceutical Co., Ltd. | 7 | 5 | 2 |
| 3 | Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized | 6 | 1 | 0 |
| 4 | Zhang Feng Su Yue Pharma (Guangzhou) Co., Ltd. romanized | 6 | 1 | 0 |
| 5 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 5 | 3 | 0 |
| 6 | Ke Xing Biopharmaceutical Co., Ltd. romanized | 5 | 1 | 0 |
| 7 | Henan Sheng Bai Quan Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 8 | Janssen Research & Development LLC | 4 | 3 | 0 |
| 9 | Shanghai He Huang Pharma Co., Ltd. romanized | 4 | 2 | 0 |
| 10 | Terumo Corporation Kofu Factory | 4 | 1 | 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
87 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/03/19Import · Class 3.1 | 帕博利珠单抗注射液 · No verified English nameJXSS2600023 | MSD International Business GmbH; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd |
| 2026/03/19Import · Class 1 | AZD2936 · No verified English nameJXSL2600080 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/03/19Generic · Class 3 | 伏硫西汀滴剂 · No verified English nameCYHS2600685 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2026/03/19Generic · Class 3 | 硫酸沙丁胺醇口服溶液 · No verified English nameCYHS2600674 | Jinan Jing Sheng Technology Co., Ltd. romanized; Hubei Wei Sen Pharmaceutical Co., Ltd. romanized |
| 2026/03/19Generic · Class 3 | Ketotifen Fumarate Oral SolutionCYHS2600673 | Zhejiang Hang Kang Pharma Co., Ltd. romanized |
| 2026/03/19Generic · Class 3 | 苯磺酸氨氯地平口服溶液 · No verified English nameCYHS2600672 | Jinan Jing Sheng Technology Co., Ltd. romanized; Hubei Wei Sen Pharmaceutical Co., Ltd. romanized |
| 2026/03/19Generic · Class 3 | Methylprednisolone Aceponate CreamCYHL2600037 | Chongqing Huapont Pharmaceutical Co., Ltd. |
| 2026/03/19New drug · Class 1.1 | 三皮强心颗粒 · No verified English nameCXZL2600031 | Wei Yin Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/03/19New drug · Class 1 | 注射用FG-M131 · No verified English nameCXSL2600338 | Ming Ji Biopharmaceutical (Beijing) Co., Ltd. romanized |
| 2026/03/19New drug · Class 1.3 | 流感病毒裂解疫苗(CpG佐剂) · No verified English nameCXSL2600337 | Hua Pu Shijiazhuang Pharmaceuticals Co., Ltd. romanized; Huan Ke (Hebei) Bio Technology Co., Ltd. romanized |
| 2026/03/19New drug · Class 2.2 | QL2107注射液 · No verified English nameCXSL2600336 | Qilu Pharmaceutical Co., Ltd. |
| 2026/03/19New drug · Class 1 | SCTB39G注射液 · No verified English nameCXSL2600334 | Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized |
| 2026/03/19New drug · Class 1 | SCTB41注射液 · No verified English nameCXSL2600333 | Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized |
| 2026/03/19New drug · Class 1 | 注射用YL211 · No verified English nameCXSL2600332 | Suzhou Yi Lian Biopharmaceuticals Co., Ltd. romanized |
| 2026/03/19New drug · Class 1 | 硫酸益母草碱片 · No verified English nameCXHL2600342 | Yi Nuo Pharmaceuticals (Guangdong) Co., Ltd. romanized |
| 2026/03/19New drug · Class 1 | HZ-A-018胶囊 · No verified English nameCXHL2600341 | Hangzhou He Zheng Pharmaceuticals Co., Ltd. romanized |
| 2026/03/19New drug · Class 1 | 硫酸益母草碱片 · No verified English nameCXHL2600340 | Yi Nuo Pharmaceuticals (Guangdong) Co., Ltd. romanized |
| 2026/03/19New drug · Class 1 | MN-08片 · No verified English nameCXHL2600339 | Guangzhou Xi Que Pharmaceuticals Co., Ltd. romanized |
| 2026/03/19New drug · Class 1 | 替恩戈替尼片 · No verified English nameCXHL2600338 | Yao Jie An Kang (Nanjing) Technology Co., Ltd. romanized |
| 2026/03/19New drug · Class 1 | 替恩戈替尼片 · No verified English nameCXHL2600337 | Yao Jie An Kang (Nanjing) Technology Co., Ltd. romanized |
| 2026/03/19New drug · Class 1 | 替恩戈替尼片 · No verified English nameCXHL2600336 | Yao Jie An Kang (Nanjing) Technology Co., Ltd. romanized |
| 2026/03/19New drug · Class 1 | HRS-4508片 · No verified English nameCXHL2600335 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/03/18Import · Class 1 | JNJ-79635322 · No verified English nameJXSL2600082 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2026/03/18Import · Class 1 | JNJ-79635322 · No verified English nameJXSL2600081 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2026/03/18Generic · Class 3 | Tranexamic Acid and Sodium Chloride InjectionCYHS2600670 | Anhui Feng Yuan Pharma Co., Ltd. Huai Hai Pharmaceutical Factory romanized |
| 2026/03/18New drug · Class 1 | 注射用QLS5133 · No verified English nameCXSL2600335 | Qilu Pharmaceutical Co., Ltd. |
| 2026/03/17Import · Class 1 | Brenipatide注射液 · No verified English nameJXHL2600085 | Eli Lillly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2026/03/17Import · Class 1 | Brenipatide注射液 · No verified English nameJXHL2600084 | Eli Lillly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2026/03/17Import · Class 1 | Brenipatide注射液 · No verified English nameJXHL2600083 | Eli Lillly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2026/03/17New drug · Class 2.4 | 注射用盐酸曲拉西利 · No verified English nameCXHL2600334 | Xian Sheng Zai Ming Pharmaceuticals Co., Ltd. romanized |
57 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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