YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 370 drug applications between 23 August 2023 and 29 August 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 62, covering 47 drug names.
2023/08/23 – 2023/08/29
- New acceptances this week
- 370
- Drugs with new generic filings (by drug name, de-duplicated)
- 47
- Accepted this week, now under review
- 1
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
370filings, 62 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 228 |
| Generic | 62 |
| New drug | 48 |
| Unspecified | 11 |
| Import | 11 |
| Import re-registration | 10 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 240 |
| TCM | 90 |
| Therapeutic biologic | 34 |
| Biologic | 3 |
| Prophylactic biologic | 3 |
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
47 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Potassium Chloride Injection | 3 | 2 | 10 |
| 2 | Tadalafil Tablets | 3 | 1 | 23 |
| 3 | Rivaroxaban Tablets | 3 | 1 | 3 |
| 4 | Oseltamivir Phosphate For Oral Suspension | 2 | 2 | 2 |
| 5 | Montelukast Sodium Chewable Tablets | 2 | 1 | 4 |
| 6 | 注射用头孢唑肟钠 · No verified English name | 2 | 1 | 4 |
| 7 | Nicorandil for Injection | 2 | 1 | 1 |
| 8 | Magnesium Sulfate Injection | 2 | 1 | 7 |
| 9 | Oseltamivir Phosphate Capsules | 2 | 1 | 39 |
| 10 | Minoxidil Topical Solution | 2 | 1 | 0 |
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
190 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Xiu Zheng Pharma Group Tian Han Pharma Co., Ltd. romanized | 59 | 54 | 0 |
| 2 | Guizhou Rui He Pharmaceutical Co., Ltd. romanized | 15 | 15 | 0 |
| 3 | AstraZeneca AB | 7 | 3 | 0 |
| 4 | Celgene Corporation | 6 | 1 | 0 |
| 5 | GE Healthcare AS | 6 | 1 | 0 |
| 6 | Sanofi Winthrop Industrie | 6 | 1 | 0 |
| 7 | Sanofi-Aventis Deutschland GmbH | 5 | 5 | 0 |
| 8 | Novartis Europharm Limited | 5 | 2 | 0 |
| 9 | Qilu Pharmaceutical Co., Ltd. | 5 | 2 | 0 |
| 10 | Hainan Si Da Pharmaceutical Co., Ltd. romanized | 5 | 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
85 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/08/29Import · Class 3.1 | 四价人乳头瘤病毒疫苗(酿酒酵母) · No verified English nameJXSS2300072 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd. |
| 2023/08/29Import · Class 3.1 | 四价人乳头瘤病毒疫苗(酿酒酵母) · No verified English nameJXSS2300071 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd. |
| 2023/08/29Generic · Class 3 | Norepinephrine Bitartrate InjectionCYHS2302293 | Jiangsu Jiang Feng Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Wu Zhong Pharmaceuticals Group Co., Ltd. Suzhou Pharmaceutical Factory romanized |
| 2023/08/29Generic · Class 3 | Fludeoxyglucose[18F] InjectionCYHS2302290 | Guangdong Xian Tong Fen Zi Ying Xiang Technology Co., Ltd. romanized |
| 2023/08/29Generic · Class 3 | Polymyxin B sulfate for InjectionCYHS2302289 | Hainan Brilliant Pharmaceutical Co., Ltd. |
| 2023/08/29New drug · Class 2.3 | 桑枝总生物碱片 · No verified English nameCXZL2300054 | Beijing Wu He Bo Ao Pharma Co., Ltd. romanized |
| 2023/08/29New drug · Class 1 | ALMB-0166注射液 · No verified English nameCXSL2300580 | Shanghai En Le Mai Bio Technology Co., Ltd. romanized |
| 2023/08/29New drug · Class 3.3 | 重组抗PD-1人源化单克隆抗体注射液 · No verified English nameCXSL2300579 | Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized |
| 2023/08/29New drug · Class 1 | QLR12018片 · No verified English nameCXHL2300924 | Qilu Pharmaceutical Co., Ltd. |
| 2023/08/29New drug · Class 1 | QLR12018片 · No verified English nameCXHL2300923 | Qilu Pharmaceutical Co., Ltd. |
| 2023/08/29New drug · Class 1 | QLR12018片 · No verified English nameCXHL2300922 | Qilu Pharmaceutical Co., Ltd. |
| 2023/08/29New drug · Class 1 | QLR12018片 · No verified English nameCXHL2300921 | Qilu Pharmaceutical Co., Ltd. |
| 2023/08/29New drug · Class 1 | YZJ-6097片 · No verified English nameCXHL2300920 | Shanghai Hai Yan Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/08/29New drug · Class 1 | YZJ-6097片 · No verified English nameCXHL2300919 | Shanghai Hai Yan Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/08/29New drug · Class 2.4 | 硫酸锌片 · No verified English nameCXHL2300918 | Beijing Hui Cheng Rui Xiang Pharmaceuticals Bio Technology Co., Ltd. romanized |
| 2023/08/28New drug · Class 1.1 | 骨性关节炎软膏 · No verified English nameCXZL2300053 | Yi Wu Shi Zhen Wei Zhong Cao Yao Technology Kai Fa Co., Ltd. romanized |
| 2023/08/28New drug · Class 1 | 注射用BC001 · No verified English nameCXSL2300578 | Sichuan Lu Zhou Bu Zhang Biopharmaceutical Co., Ltd. romanized |
| 2023/08/26Generic · Class 3 | Amlodipine Besylate and Benazepril Hydrochloride CapsulesCYHS2302279 | Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized |
| 2023/08/26Generic · Class 3 | Potassium Chloride InjectionCYHS2302276 | Guangdong Ke Hong Pharma Co., Ltd. romanized; Henan Ke Lun Pharma Co., Ltd. romanized |
| 2023/08/26Generic · Class 3 | Potassium Chloride InjectionCYHS2302275 | Guangdong Ke Hong Pharma Co., Ltd. romanized; Henan Ke Lun Pharma Co., Ltd. romanized |
| 2023/08/26Generic · Class 3 | Oseltamivir Phosphate For Oral SuspensionCYHS2302274 | Guangdong Hong Shan Hu Pharma Co., Ltd. romanized; Tianjin Han Rui Pharma Co., Ltd. romanized |
| 2023/08/26New drug · Class 1 | SCG101自体T细胞注射液 · No verified English nameCXSL2300577 | Xing Han De Biopharmaceuticals (Da Lian) Co., Ltd. romanized |
| 2023/08/26New drug · Class 3.3 | 重组抗CTLA-4全人单克隆抗体注射液 · No verified English nameCXSL2300576 | Shanghai Fu Hong Han Lin Biopharmaceutical Co., Ltd. romanized |
| 2023/08/26New drug · Class 1 | IMP4297胶囊 · No verified English nameCXHS2300074 | Shanghai Ying Pai Pharma Co., Ltd. romanized; Wuxi He Quan Pharma Co., Ltd. romanized |
| 2023/08/26New drug · Class 1 | IMP4297胶囊 · No verified English nameCXHS2300073 | Shanghai Ying Pai Pharma Co., Ltd. romanized; Wuxi He Quan Pharma Co., Ltd. romanized |
| 2023/08/26New drug · Class 1 | SZJK-0421片 · No verified English nameCXHL2300917 | Shenzhen Ji Kang Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/08/26New drug · Class 2.2 | 司美格鲁肽注射液 · No verified English nameCXHL2300916 | Hua Run Shuang He Pharma Co., Ltd. romanized |
| 2023/08/26New drug · Class 2.2 | 司美格鲁肽注射液 · No verified English nameCXHL2300915 | Hua Run Shuang He Pharma Co., Ltd. romanized |
| 2023/08/25Import · Class 1 | AZD5335 · No verified English nameJXSL2300158 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2023/08/25Import · Class 1 | AZD5305 · No verified English nameJXHL2300200 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
55 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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