YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 85 drug applications between 1 May 2024 and 7 May 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 18, covering 13 drug names.
2024/05/01 – 2024/05/07
- New acceptances this week
- 85
- Drugs with new generic filings (by drug name, de-duplicated)
- 13
- Accepted this week, now under review
- 0
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
85filings, 18 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 47 |
| Generic | 18 |
| New drug | 9 |
| Import | 6 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 56 |
| TCM | 15 |
| Therapeutic biologic | 13 |
| 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
13 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Lactulose Oral Solution | 2 | 1 | 34 |
| 2 | Procaterol Hydrochloride Solution for Inhalation | 2 | 1 | 2 |
| 3 | Perindopril arginine and amlodipine besylate tablets | 2 | 1 | 3 |
| 4 | Dabigatran Etexilate Capsules | 2 | 1 | 2 |
| 5 | Avanafil Tablets | 2 | 1 | 2 |
| 6 | Sodium Picosulfate Oral Solution | 1 | 1 | 0 |
| 7 | Perindopril arginine and amlodipine besylate tablets | 1 | 1 | 0 |
| 8 | Perindopril Arginine and Amlodipine Besylate Tablets(III) | 1 | 1 | 3 |
| 9 | 氯化钙注射液 · No verified English name | 1 | 1 | 6 |
| 10 | Urapidil Hydrochloride Injection | 1 | 1 | 6 |
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
57 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Chongqing Sai Wei Pharma Co., Ltd. romanized | 5 | 1 | 0 |
| 2 | Hubei Yan Huang Ben Cao Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 3 | Heilongjiang Song Ci Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 4 | Jiangxi Shimei Pharmaceutical Co., Ltd | 4 | 3 | 4 |
| 5 | Takeda Pharmaceuticals International AG Ireland Branch | 3 | 1 | 0 |
| 6 | Anhui Jin Ma Pharma Co., Ltd. romanized | 2 | 2 | 0 |
| 7 | Jiangxi Xing Lin Bai Ma Pharma Co., Ltd. romanized | 2 | 2 | 0 |
| 8 | AbbVie Inc. | 2 | 1 | 0 |
| 9 | Genzyme Corporation | 2 | 1 | 0 |
| 10 | GlaxoSmithKline Trading Services Limited | 2 | 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
24 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/05/07Import · Class 1 | Fitusiran注射液 · No verified English nameJXHS2400034 | Genzyme Corporation; Vetter Pharma-Fertigung GmbH & Co. KG; Sanofi (China) Investment Co. Ltd. |
| 2024/05/07Import · Class 1 | Fitusiran注射液 · No verified English nameJXHS2400033 | Genzyme Corporation; Vetter Pharma-Fertigung GmbH & Co. KG; Sanofi (China) Investment Co. Ltd. |
| 2024/05/07Import · Class 1 | RO7434656注射液 · No verified English nameJXHL2400098 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2024/05/07Import · Class 2.2 | Upadacitinib口服溶液 · No verified English nameJXHL2400097 | AbbVie Inc.; AbbVie Pharmaceutical Trading(Shanghai) Co. Ltd. |
| 2024/05/07Import · Class 2.2 | Upadacitinib口服溶液 · No verified English nameJXHL2400096 | AbbVie Inc.; AbbVie Pharmaceutical Trading(Shanghai) Co. Ltd. |
| 2024/05/07Generic · Class 3 | Minoxidil LinimentCYHS2401338 | Xian De Li Bio Chemical Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2024/05/07Generic · Class 3 | Procaterol Hydrochloride Solution for InhalationCYHS2401337 | Hainan Jin Rui Bao Pharmaceuticals Technology Co., Ltd. romanized; Yang Zhou Zhong Bao Pharma Co., Ltd. romanized |
| 2024/05/07Generic · Class 3 | Procaterol Hydrochloride Solution for InhalationCYHS2401336 | Hainan Jin Rui Bao Pharmaceuticals Technology Co., Ltd. romanized; Yang Zhou Zhong Bao Pharma Co., Ltd. romanized |
| 2024/05/07Generic · Class 3 | Alendronate Sodium Oral SolutionCYHS2401335 | Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized |
| 2024/05/07Generic · Class 3 | 氯化钙注射液 · No verified English nameCYHS2401334 | Guangxi Ming Lei Wei Sheng Pharmaceutical Co., Ltd. romanized |
| 2024/05/07Generic · Class 3 | 铜[64Cu]氧奥曲肽注射液 · No verified English nameCYHL2400082 | Beijing Xian Tong International Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/05/07Generic · Class 3 | Sodium Picosulfate Oral SolutionCYHL2400081 | Beijing Bai Ya Joint Drug Research Institute Co., Ltd. romanized |
| 2024/05/07New drug · Class 1.1 | 清血败毒丸 · No verified English nameCXZL2400023 | Jiangsu Zhong Yong Hong Rui Pharmaceutical Co., Ltd. romanized |
| 2024/05/07New drug · Class 1.2 | 带状疱疹IN001 mRNA疫苗 · No verified English nameCXSL2400287 | Shenzhen Shen Xin Bio Technology Co., Ltd. romanized |
| 2024/05/07New drug · Class 1 | 注射用QLS4131 · No verified English nameCXSL2400286 | Qilu Pharmaceutical Co., Ltd. |
| 2024/05/06Generic · Class 3 | Avanafil TabletsCYHS2401333 | Kunming Ji Da Pharmaceutical Co., Ltd. romanized |
| 2024/05/06Generic · Class 3 | Avanafil TabletsCYHS2401332 | Kunming Ji Da Pharmaceutical Co., Ltd. romanized |
| 2024/05/06New drug · Class 1 | TAL-T细胞注射液 · No verified English nameCXSL2400285 | Guangzhou Fan En Bio Technology Co., Ltd. romanized |
| 2024/05/01Import · Class 2.2 | 帕博利珠单抗注射液 · No verified English nameJXSL2400084 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd |
| 2024/05/01New drug · Class 1 | CNK-UT002细胞注射液 · No verified English nameCXSL2400284 | Yi Zun Biopharmaceuticals (Zhejiang) Co., Ltd. romanized |
| 2024/05/01New drug · Class 1 | 注射用sacituzumab tirumotecan · No verified English nameCXSL2400283 | Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized |
| 2024/05/01New drug · Class 1 | 酒石酸泰贝西利胶囊 · No verified English nameCXHS2400039 | Bei Da Pharma Co., Ltd. romanized |
| 2024/05/01New drug · Class 1 | SGB-3908注射液 · No verified English nameCXHL2400426 | Suzhou Sheng Yin Biopharmaceuticals Co., Ltd. romanized |
| 2024/05/01New drug · Class 2.2 | HZ031口溶膜 · No verified English nameCXHL2400425 | Zhejiang He Ze Pharmaceuticals Technology Co., Ltd. romanized |
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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