YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 258 drug applications between 28 October 2022 and 3 November 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 48, covering 38 drug names.
2022/10/28 – 2022/11/03
- New acceptances this week
- 258
- Drugs with new generic filings (by drug name, de-duplicated)
- 38
- 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
258filings, 48 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 114 |
| Generic | 48 |
| New drug | 44 |
| Import | 25 |
| Import re-registration | 17 |
| Unspecified | 10 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 189 |
| Therapeutic biologic | 40 |
| TCM | 26 |
| Prophylactic biologic | 2 |
| 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
38 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Ibuprofen Injection | 2 | 2 | 8 |
| 2 | Olaparib Tablets | 2 | 1 | 0 |
| 3 | Empagliflozin Tablets | 2 | 1 | 18 |
| 4 | Urapidil Hydrochloride Injection | 2 | 1 | 6 |
| 5 | Ambroxol Hydrochloride Drops | 2 | 1 | 8 |
| 6 | Magnesium Sulfate Injection | 2 | 1 | 7 |
| 7 | 羟乙基淀粉130/0.4氯化钠注射液 · No verified English name | 2 | 1 | 0 |
| 8 | Esomeprazole Magnesium Enteric-Coated Capsules | 2 | 1 | 4 |
| 9 | Dapagliflozin Tablets | 2 | 1 | 84 |
| 10 | Norepinephrine Bitartrate Injection | 2 | 1 | 9 |
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
143 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Novo Nordisk A/S | 10 | 2 | 0 |
| 2 | Hubei Mei Lin Pharma Co., Ltd. romanized | 9 | 6 | 0 |
| 3 | Guangdong Dong Yang Guang Pharma Co., Ltd. romanized | 9 | 1 | 0 |
| 4 | Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized | 6 | 6 | 0 |
| 5 | Annora Pharma Private Limited | 6 | 2 | 0 |
| 6 | Shandong Han Fang Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 7 | Boehringer Ingelheim International GmbH | 5 | 3 | 0 |
| 8 | Anhui Mei Yu Pharmaceutical Co., Ltd. romanized | 5 | 3 | 0 |
| 9 | Qilu Pharmaceutical Co., Ltd. | 5 | 3 | 2 |
| 10 | Chengdu Shi Hai Tong Pharma Co., Ltd. romanized | 5 | 2 | 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
84 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/11/03Generic · Class 3 | Nimodipine Oral SolutionCYHS2201882 | Shanghai Ao Quan Biopharmaceuticals Technology Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2022/11/03New drug · Class 2.3 | 阿利沙坦酯氨氯地平片 · No verified English nameCXHS2200061 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized |
| 2022/11/03New drug · Class 1 | BPI-452080 片 · No verified English nameCXHL2200865 | Bei Da Pharma Co., Ltd. romanized |
| 2022/11/03New drug · Class 1 | BPI-452080 片 · No verified English nameCXHL2200864 | Bei Da Pharma Co., Ltd. romanized |
| 2022/11/02Import · Class 2.4 | 亮丙瑞林注射乳剂 · No verified English nameJXHL2200328 | Foresee Pharmaceuticals Co. Ltd; Changchun GeneScience Pharmaceuticals Co. Ltd. |
| 2022/11/02Import · Class 2.2; 2.4 | CBT-001眼用乳液 · No verified English nameJXHL2200327 | Cloudbreak Therapeutics LLC; Cloudbreak Bio-Pharmaceutical Science and Technology(Guangzhou)Co. Ltd |
| 2022/11/02Import · Class 2.2; 2.4 | CBT-001眼用乳液 · No verified English nameJXHL2200326 | Cloudbreak Therapeutics LLC; Cloudbreak Bio-Pharmaceutical Science and Technology(Guangzhou)Co. Ltd |
| 2022/11/02Import · Class 1 | SAR443122 硬胶囊 · No verified English nameJXHL2200325 | Sanofi-Aventis Recherche & Développement |
| 2022/11/02Import · Class 1 | SAR443122 硬胶囊 · No verified English nameJXHL2200324 | Sanofi-Aventis Recherche & Développement |
| 2022/11/02Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2201876 | Jin Zhou Ao Hong Pharma Co., Ltd. romanized |
| 2022/11/02New drug · Class 2.2 | 重组人血小板生成素注射液 · No verified English nameCXSS2200089 | Shenyang San Sheng Pharmaceutical Co., Ltd. romanized |
| 2022/11/02New drug · Class 2.2 | 重组人血小板生成素注射液 · No verified English nameCXSS2200088 | Shenyang San Sheng Pharmaceutical Co., Ltd. romanized |
| 2022/11/02New drug · Class 1 | 注射用SHR-A1921 · No verified English nameCXSL2200556 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2022/11/02New drug · Class 1 | 阿得贝利单抗注射液 · No verified English nameCXSL2200555 | Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2022/11/02New drug · Class 1 | 注射用SHR-A1811 · No verified English nameCXSL2200554 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2022/11/02New drug · Class 1 | 注射用间充质干细胞(脐带) · No verified English nameCXSL2200553 | Tianjin Ang Sai Xi Bao Ji Yin Gong Cheng Co., Ltd. romanized |
| 2022/11/02New drug · Class 1 | ZLT-001注射液 · No verified English nameCXSL2200552 | Guangzhou Zhi Ling Biopharmaceuticals Co., Ltd. romanized |
| 2022/11/02New drug · Class 2.2 | 利培酮口溶膜 · No verified English nameCXHS2200060 | Qilu Pharmaceutical Co., Ltd. |
| 2022/11/02New drug · Class 2.2 | 利培酮口溶膜 · No verified English nameCXHS2200059 | Qilu Pharmaceutical Co., Ltd. |
| 2022/11/02New drug · Class 1 | BGT-002片 · No verified English nameCXHL2200863 | Bo Ji Yuan (Shanghai) Biopharmaceuticals Co., Ltd. romanized |
| 2022/11/02New drug · Class 1 | BGT-002片 · No verified English nameCXHL2200862 | Bo Ji Yuan (Shanghai) Biopharmaceuticals Co., Ltd. romanized |
| 2022/11/02New drug · Class 1 | TDI01混悬液 · No verified English nameCXHL2200861 | Beijing Tai De Pharmaceutical Co., Ltd. romanized |
| 2022/11/02New drug · Class 2.4 | 奥布替尼片 · No verified English nameCXHL2200860 | Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/11/02New drug · Class 2.2 | 枸橼酸西地那非分散片 · No verified English nameCXHL2200858 | Shanghai Ao Quan Biopharmaceuticals Technology Co., Ltd. romanized |
| 2022/11/01Import · Class 1 | BION-1301注射液 · No verified English nameJXSL2200190 | Chinook Therapeutics Inc.; SanReno Therapeutics (Shanghai) Limited |
| 2022/11/01Import · Class 1 | KarXT胶囊 · No verified English nameJXHL2200323 | Karuna Therapeutics Inc.; Zai Lab (Shanghai) Co. Ltd. |
| 2022/11/01Import · Class 1 | KarXT胶囊 · No verified English nameJXHL2200322 | Karuna Therapeutics Inc.; Zai Lab (Shanghai) Co. Ltd. |
| 2022/11/01Import · Class 1 | KarXT胶囊 · No verified English nameJXHL2200321 | Karuna Therapeutics Inc.; Zai Lab (Shanghai) Co. Ltd. |
| 2022/11/01Import · Class 1 | AZD2693注射液 · No verified English nameJXHL2200320 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2022/11/01Import · Class 1 | AZD2693注射液 · No verified English nameJXHL2200319 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
54 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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